Cord Blood Registry (CBR), the global leader in the collection and preservation of newborn stem cells from umbilical cord blood, announced its support of legislation introduced yesterday by U.S. Representatives Ron Kind (D-WI), Wally Herger (R-CA), Artur Davis (D-AL), Bill Pascrell Jr. (D-NJ) and Mike Thompson (D-CA) entitled the "Family Cord Blood Banking Act." This important legislation will amend the IRS Code to allow individuals and couples to use tax advantaged dollars to pay for umbilical cord blood banking services through flexible spending accounts (FSAs), health savings accounts (HSAs), health reimbursement arrangements (HRAs) or the medical expenses tax deduction.
Speaking about the bill's introduction, Rep. Ron Kind, the legislation's chief sponsor and a Member of the House Ways and Means Subcommittee on Health, said, "This legislation supports families that choose this potentially life-saving investment by providing tax incentives for these medical expenses."
Cord blood stem cells have been used in more than 14,000 transplants worldwide during the last 20 years to treat more than 70 diseases in both adults and children and are now showing great promise for regenerative medicine applications, including treatment for type 1 diabetes, brain injury, cerebral palsy and hearing loss. For many families, cord blood banking is the best option for treating and curing disease; however, the cost of family umbilical cord blood banking ($2,000 the first year; $125 per year thereafter) can present a challenge for families on fixed incomes.
Current tax laws arbitrarily restrict how families can use tax advantaged dollars in FSAs, HSAs, HRAs, or through the medical expenses tax deduction. "Families may pay for over-the-counter cough syrups or heartburn pills using these dollars, but not cord blood banking services," said David Zitlow, senior vice president of public affairs and communications at CBR. "These limitations are unfair and even unwise - families who opt to deposit into tax advantaged health accounts should have the discretion to spend those dollars as they see fit on qualified medical expenses."
The legislation is also likely to speed important research using cord blood stem cells. "Research and clinical trials involving cord blood will require more children to have a source of their own cord blood stem cells available for transplant. Consequently, legislation that makes it easier for families to bank cord blood will definitely speed up the time table for life-saving research and will allow scientists to unlock the vast potential of these amazing cells on a much quicker basis," said Dr. David Harris, Cord Blood Registry's Scientific Director and a stem cell researcher at the University of Arizona.
"The Family Cord Blood Banking Act" is supported by the Coalition for Regenerative Stem Cell Medicine, which includes groups like the Brain Injury Association of America (BIAA), Association of Nurse Practitioners in Women's Health, The Parents Guide to Cord Blood Foundation and a growing number of organizations, researchers, and disease advocacy groups dedicated to raising awareness and lowering financial barriers of access to cord blood stem cells.
About Cord Blood Registry
Cord Blood Registry(R) (CBR(R)) is the world's largest stem cell bank, focused on the collection, processing and storage of newborn stem cells from umbilical cord blood and ensuring their viability for medical use. CBR is the most recommended family cord blood bank by obstetricians and was the first family bank accredited by AABB (formerly the American Association of Blood Banks). The company has been profitable and cash flow positive from operations on a cumulative basis since 1999. To date, CBR has processed and stored cord blood units for more than 260,000 newborns from around the world and has released more client cord blood units for specific therapeutic use than any other family cord blood bank. The company's research and development efforts are focused on helping the world's leading clinical researchers advance regenerative medical therapies using cord blood stem cells as well as enhancing its industry-leading technical innovations for stem cell collection, processing and storage that optimize quality and cell yield. For more information, visit CordBlood.
Cord Blood Registry
cordblood
понедельник, 6 июня 2011 г.
воскресенье, 5 июня 2011 г.
Kosan Opens Registration Program For Lead Hsp90 Inhibitor, Tanespimycin, In Multiple Myeloma
Kosan Biosciences
Incorporated (Nasdaq: KOSN) today announced that the TIME-2 trial is open
and enrolling patients. This marks the opening of Kosan's Tanespimycin in
Myeloma Evaluation or "TIME" registration program for its lead Hsp90
inhibitor, tanespimycin (KOS-953). The TIME program includes two clinical
trials: TIME-1 and TIME-2. TIME-1 is a pivotal Phase 3 trial to be
conducted in a first-relapse patient population. TIME-2, which is designed
to be supportive of the TIME-1 trial, is a Phase 2/3 trial in patients with
relapsed-refractory disease. TIME-2 also has the potential to support
registration in a relapsed-refractory setting. The TIME program will use
Kosan's new, proprietary injectable suspension formulation of tanespimycin.
Tanespimycin is the first Hsp90 inhibitor to enter a registration program.
"The opening of our TIME registration program is a major achievement
for our company and a milestone in the advancement of Hsp90 inhibition, a
promising new approach to cancer therapy," said Robert G. Johnson, Jr.,
M.D., Ph.D., Kosan's President and Chief Executive Officer. "We continue to
be encouraged by the high level of durable responses we observe when
tanespimycin combined with bortezomib (Velcade(R)) is administered to
patients with relapsed-refractory multiple myeloma, as well as by
tanespimycin's manageable safety profile. We believe that a successful
outcome in the TIME-2 trial, together with data from our TIME-1 trial,
could potentially support an accelerated registration strategy for
tanespimycin in this life-threatening disease."
The TIME clinical program will utilize Kosan's improved, proprietary
injectable suspension formulation of tanespimycin injectable suspension.
The formulation is designed to provide important benefits, including
improved patient safety, due to the elimination of Cremophor(R) and the
associated need for steroid premedication to prevent hypersensitivity
reactions. Tanespimycin injectable suspension also has a potentially
enhanced intellectual property position and permits easier drug preparation
and administration compared to the prior formulation.
The TIME-2 clinical trial is being conducted at clinical sites
primarily in the US and in Europe and is anticipated to enroll
approximately 130 patients. Key aspects of the TIME-2 trial are as follows.
-- The trial is designed to test three different doses of tanespimycin in
combination with the approved dose and schedule of bortezomib
(1.3 mg/m2). The tanespimycin dose groups are 50 mg/m2, 175 mg/m2 and
340 mg/m2. Tanespimycin will be administered twice weekly as a one-hour
intravenous infusion on a cycle of two weeks of treatment every three
weeks (the same schedule as bortezomib).
-- Patients eligible to participate in the TIME-2 trial must have been
treated with and progressed following at least three prior treatments
for multiple myeloma. Prior regimens must include bortezomib and
lenalidomide (Revlimid(R)).
-- The primary endpoint of the trial is the dose response based on
objective response rate after 4 cycles of treatment. Secondary
endpoints include a comparison of response rate between the dose
groups, progression-free survival, time to treatment failure and
overall survival. Objective response rate in multiple myeloma is
measured primarily by the patient's level of M protein.
Kosan anticipates that the pivotal TIME-1 trial will begin later in
2007 or in early 2008. TIME-1 will be an open-label, randomized,
multi-center trial that is designed to enroll over 450 patients with
disease relapse following a single prior course of treatment
(first-relapse). The trial is designed to compare two groups: patients
treated with bortezomib plus tanespimycin and patients treated with
bortezomib alone. Tanespimycin will be administered at a dose of 340 mg/m2
and all patients will receive standard doses of bortezomib (1.3 mg/m2).
TIME-1 is designed with a primary endpoint of progression-free survival.
Kosan anticipates providing more background on the TIME-1 trial design upon
initiation.
About Tanespimycin
Tanespimycin has been shown to induce apoptosis of drug-sensitive and
drug-resistant multiple myeloma cell lines. Tanespimycin also inhibits
expression of various cell surface cytokines, such as IGF-1R and IL-6R,
that are involved in growth, survival and drug resistance of multiple
myeloma cells. Destabilizing client proteins with tanespimycin while
blocking their degradation with bortezomib promotes the accumulation of
cytotoxic proteins, leading to cell death.
Kosan reported data from a Phase 1b trial of tanespimycin in
combination with bortezomib at the 2007 annual meeting of the American
Society for Clinical Oncology (ASCO) on 56 patients enrolled in 7 dose
cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib;
tanespimycin administered via 1-hour infusion following the bortezomib dose
2 times per week every 2 weeks out of 3 weeks). Of these 56 patients, all
had received multiple prior chemotherapy regimens (median of 4) and 67% had
received bone marrow transplants.
In those patients who received tanespimycin across the range of doses
tested and a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response
rate including complete, partial and minimal responses was, as previously
reported, 44% (18 out of 41 patients evaluable for response). Of the 44%, 8
out of 14 patients were bortezomib-naive (57%); 7 out of 16 patients were
bortezomib-pretreated patients (44%); and 3 out of 11 patients were
bortezomib-refractory (27%). Responses in the bortezomib-refractory
patients continue to show prolonged duration (at least 10 months at the
time of data presentation at ASCO in June 2007) and meaningful reduction of
serum/urinary M-protein (greater than 89%). The combination of tanespimycin
and bortezomib was well-tolerated.
Kosan has been granted orphan drug designation for tanespimycin in
multiple myeloma in both the US and European Union.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes
of anticancer agents through clinical development -- Hsp90 (heat shock
protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary
discovery platform to generate a pipeline of potentially significant
product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple
pathways involved in cancer cell growth and survival. Tanespimycin
(KOS-953) is being tested in combination with bortezomib in patients with
multiple myeloma in a registration program called TIME. Tanespimycin is
also being studied in multiple myeloma as monotherapy, in HER2-positive
metastatic breast cancer in combination with Herceptin, and as monotherapy
in metastatic melanoma. Intravenous and oral formulations of Kosan's
second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being
evaluated in Phase 1 clinical trials in hematological cancers and in
HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to
taxanes, one of the most successful classes of anti-tumor agents. KOS-1584
is in Phase 1 clinical trials in patients with solid tumors. Kosan's
epothilone program is partnered with Roche through a global development and
commercialization agreement.
For additional information on Kosan Biosciences, please visit the
Company's website at kosan.
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995 (the "Act"). Such forward-looking statements
include but are not limited to statements related to the further
development and potential safety, efficacy, commercialization and other
characteristics of tanespimycin or tanespimycin injectable suspension,
Kosan's development plans with respect to tanespimycin, including but not
limited to Kosan's plans and timing for the initiation of TIME-2, TIME-2 as
a potential registration trial, and potential accelerated registration
strategy for tanespimycin. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. There are a number of important factors that
could cause the results of Kosan to differ materially from those indicated
by these forward-looking statements, including, among others, risks related
to the development of tanespimycin, including the risk that studies may not
demonstrate safety and efficacy sufficient to initiate additional clinical
trials, continue clinical development on the timing currently anticipated
or at all, obtain the requisite regulatory approvals or result in a
marketable product; and other risks detailed from time to time in the
Kosan's SEC reports, including its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2007 and other periodic filings with the SEC. Kosan
does not undertake any obligation to update forward-looking statements.
Velcade(R) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
Revlimid(R) (lenalidomide) is a registered trademark of Celgene Corporation
Cremophor(R) is a registered trademark of BASF Aktiengesellschaft
Kosan Biosciences Incorporated
kosan
View drug information on Herceptin.
Incorporated (Nasdaq: KOSN) today announced that the TIME-2 trial is open
and enrolling patients. This marks the opening of Kosan's Tanespimycin in
Myeloma Evaluation or "TIME" registration program for its lead Hsp90
inhibitor, tanespimycin (KOS-953). The TIME program includes two clinical
trials: TIME-1 and TIME-2. TIME-1 is a pivotal Phase 3 trial to be
conducted in a first-relapse patient population. TIME-2, which is designed
to be supportive of the TIME-1 trial, is a Phase 2/3 trial in patients with
relapsed-refractory disease. TIME-2 also has the potential to support
registration in a relapsed-refractory setting. The TIME program will use
Kosan's new, proprietary injectable suspension formulation of tanespimycin.
Tanespimycin is the first Hsp90 inhibitor to enter a registration program.
"The opening of our TIME registration program is a major achievement
for our company and a milestone in the advancement of Hsp90 inhibition, a
promising new approach to cancer therapy," said Robert G. Johnson, Jr.,
M.D., Ph.D., Kosan's President and Chief Executive Officer. "We continue to
be encouraged by the high level of durable responses we observe when
tanespimycin combined with bortezomib (Velcade(R)) is administered to
patients with relapsed-refractory multiple myeloma, as well as by
tanespimycin's manageable safety profile. We believe that a successful
outcome in the TIME-2 trial, together with data from our TIME-1 trial,
could potentially support an accelerated registration strategy for
tanespimycin in this life-threatening disease."
The TIME clinical program will utilize Kosan's improved, proprietary
injectable suspension formulation of tanespimycin injectable suspension.
The formulation is designed to provide important benefits, including
improved patient safety, due to the elimination of Cremophor(R) and the
associated need for steroid premedication to prevent hypersensitivity
reactions. Tanespimycin injectable suspension also has a potentially
enhanced intellectual property position and permits easier drug preparation
and administration compared to the prior formulation.
The TIME-2 clinical trial is being conducted at clinical sites
primarily in the US and in Europe and is anticipated to enroll
approximately 130 patients. Key aspects of the TIME-2 trial are as follows.
-- The trial is designed to test three different doses of tanespimycin in
combination with the approved dose and schedule of bortezomib
(1.3 mg/m2). The tanespimycin dose groups are 50 mg/m2, 175 mg/m2 and
340 mg/m2. Tanespimycin will be administered twice weekly as a one-hour
intravenous infusion on a cycle of two weeks of treatment every three
weeks (the same schedule as bortezomib).
-- Patients eligible to participate in the TIME-2 trial must have been
treated with and progressed following at least three prior treatments
for multiple myeloma. Prior regimens must include bortezomib and
lenalidomide (Revlimid(R)).
-- The primary endpoint of the trial is the dose response based on
objective response rate after 4 cycles of treatment. Secondary
endpoints include a comparison of response rate between the dose
groups, progression-free survival, time to treatment failure and
overall survival. Objective response rate in multiple myeloma is
measured primarily by the patient's level of M protein.
Kosan anticipates that the pivotal TIME-1 trial will begin later in
2007 or in early 2008. TIME-1 will be an open-label, randomized,
multi-center trial that is designed to enroll over 450 patients with
disease relapse following a single prior course of treatment
(first-relapse). The trial is designed to compare two groups: patients
treated with bortezomib plus tanespimycin and patients treated with
bortezomib alone. Tanespimycin will be administered at a dose of 340 mg/m2
and all patients will receive standard doses of bortezomib (1.3 mg/m2).
TIME-1 is designed with a primary endpoint of progression-free survival.
Kosan anticipates providing more background on the TIME-1 trial design upon
initiation.
About Tanespimycin
Tanespimycin has been shown to induce apoptosis of drug-sensitive and
drug-resistant multiple myeloma cell lines. Tanespimycin also inhibits
expression of various cell surface cytokines, such as IGF-1R and IL-6R,
that are involved in growth, survival and drug resistance of multiple
myeloma cells. Destabilizing client proteins with tanespimycin while
blocking their degradation with bortezomib promotes the accumulation of
cytotoxic proteins, leading to cell death.
Kosan reported data from a Phase 1b trial of tanespimycin in
combination with bortezomib at the 2007 annual meeting of the American
Society for Clinical Oncology (ASCO) on 56 patients enrolled in 7 dose
cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib;
tanespimycin administered via 1-hour infusion following the bortezomib dose
2 times per week every 2 weeks out of 3 weeks). Of these 56 patients, all
had received multiple prior chemotherapy regimens (median of 4) and 67% had
received bone marrow transplants.
In those patients who received tanespimycin across the range of doses
tested and a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response
rate including complete, partial and minimal responses was, as previously
reported, 44% (18 out of 41 patients evaluable for response). Of the 44%, 8
out of 14 patients were bortezomib-naive (57%); 7 out of 16 patients were
bortezomib-pretreated patients (44%); and 3 out of 11 patients were
bortezomib-refractory (27%). Responses in the bortezomib-refractory
patients continue to show prolonged duration (at least 10 months at the
time of data presentation at ASCO in June 2007) and meaningful reduction of
serum/urinary M-protein (greater than 89%). The combination of tanespimycin
and bortezomib was well-tolerated.
Kosan has been granted orphan drug designation for tanespimycin in
multiple myeloma in both the US and European Union.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes
of anticancer agents through clinical development -- Hsp90 (heat shock
protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary
discovery platform to generate a pipeline of potentially significant
product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple
pathways involved in cancer cell growth and survival. Tanespimycin
(KOS-953) is being tested in combination with bortezomib in patients with
multiple myeloma in a registration program called TIME. Tanespimycin is
also being studied in multiple myeloma as monotherapy, in HER2-positive
metastatic breast cancer in combination with Herceptin, and as monotherapy
in metastatic melanoma. Intravenous and oral formulations of Kosan's
second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being
evaluated in Phase 1 clinical trials in hematological cancers and in
HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to
taxanes, one of the most successful classes of anti-tumor agents. KOS-1584
is in Phase 1 clinical trials in patients with solid tumors. Kosan's
epothilone program is partnered with Roche through a global development and
commercialization agreement.
For additional information on Kosan Biosciences, please visit the
Company's website at kosan.
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995 (the "Act"). Such forward-looking statements
include but are not limited to statements related to the further
development and potential safety, efficacy, commercialization and other
characteristics of tanespimycin or tanespimycin injectable suspension,
Kosan's development plans with respect to tanespimycin, including but not
limited to Kosan's plans and timing for the initiation of TIME-2, TIME-2 as
a potential registration trial, and potential accelerated registration
strategy for tanespimycin. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. There are a number of important factors that
could cause the results of Kosan to differ materially from those indicated
by these forward-looking statements, including, among others, risks related
to the development of tanespimycin, including the risk that studies may not
demonstrate safety and efficacy sufficient to initiate additional clinical
trials, continue clinical development on the timing currently anticipated
or at all, obtain the requisite regulatory approvals or result in a
marketable product; and other risks detailed from time to time in the
Kosan's SEC reports, including its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2007 and other periodic filings with the SEC. Kosan
does not undertake any obligation to update forward-looking statements.
Velcade(R) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
Revlimid(R) (lenalidomide) is a registered trademark of Celgene Corporation
Cremophor(R) is a registered trademark of BASF Aktiengesellschaft
Kosan Biosciences Incorporated
kosan
View drug information on Herceptin.
суббота, 4 июня 2011 г.
Anti-Coagulants Better Than Anti-Platelet Therapy For Stroke Prevention
People with atrial fibrillation (AF) have irregular heart beats and have a tendency to form blood clots in the upper chambers (atria) of their hearts. These clots can then travel to the brain, block vessels and cause a stroke. One way of reducing the risk of this occurring is to give drugs that limit the blood's ability to create clots. Two commonly used options are anticoagulants that inhibit the clotting process (e.g. warfarin), and drugs such as aspirin that make blood platelets less likely to bind together and trigger a clot.
In standard medical practice, anticoagulants are often given to people with AF who are at high risk of strokes, while anti-platelet treatments are offered to people at lower risk.
A team of Cochrane Researchers set out to compare the relative benefits of these two treatments. After searching the medical literature, they drew on data found in eight trials that together involved a total of 9598 people who had AF but had not suffered stokes so far.
The results showed that anticoagulants were more successful than anti-platelet therapies at reducing stroke. They reduced the risk of a stroke in people with AF by about 33% compared with anti-platelet therapies. The anti-platelet therapies did, however, still have an effect, reducing the risk by 20% when compared to people who were given no treatment (controls).
"Adjusted-dose warfarin offers larger, more predictable reductions in stroke for AF patients who can receive it," says lead researcher Maria Aguilar, who works in the department of Neurology at the Mayo Clinic Scottsdale, Arizona, USA.
While it is clear that both drugs can bring benefit, it is unclear at what point a person should start to take them.
"The threshold of benefit that would warrant anticoagulation remains controversial and depends on patient preferences and availability of optimal anticoagulation monitoring," says Aguilar.
Jadad AR, Cook DJ, Jones A, Klassen TP, Tugwell P, Moher M, et al. Methodology and reports of systematic Reviews and meta-analysies: a comparison of Cochrane Reviews with articles published in paper-based journal.
Source: Jennifer Beal
John Wiley & Sons, Inc.
View drug information on Warfarin Sodium tablets.
In standard medical practice, anticoagulants are often given to people with AF who are at high risk of strokes, while anti-platelet treatments are offered to people at lower risk.
A team of Cochrane Researchers set out to compare the relative benefits of these two treatments. After searching the medical literature, they drew on data found in eight trials that together involved a total of 9598 people who had AF but had not suffered stokes so far.
The results showed that anticoagulants were more successful than anti-platelet therapies at reducing stroke. They reduced the risk of a stroke in people with AF by about 33% compared with anti-platelet therapies. The anti-platelet therapies did, however, still have an effect, reducing the risk by 20% when compared to people who were given no treatment (controls).
"Adjusted-dose warfarin offers larger, more predictable reductions in stroke for AF patients who can receive it," says lead researcher Maria Aguilar, who works in the department of Neurology at the Mayo Clinic Scottsdale, Arizona, USA.
While it is clear that both drugs can bring benefit, it is unclear at what point a person should start to take them.
"The threshold of benefit that would warrant anticoagulation remains controversial and depends on patient preferences and availability of optimal anticoagulation monitoring," says Aguilar.
Jadad AR, Cook DJ, Jones A, Klassen TP, Tugwell P, Moher M, et al. Methodology and reports of systematic Reviews and meta-analysies: a comparison of Cochrane Reviews with articles published in paper-based journal.
Source: Jennifer Beal
John Wiley & Sons, Inc.
View drug information on Warfarin Sodium tablets.
пятница, 3 июня 2011 г.
Painless, Non-Invasive And Inexpensive Test For Colon Cancer
People are often reluctant to undergo a routine but painful colonoscopy - but the consequences can be fatal. According to the American Cancer Society, colon cancer is the third most common cancer found in American men and women and kills about 50,000 Americans every year.
"85% of those who develop colon cancer have no symptoms or family history," says Prof. Nadir Arber, a professor of medicine and gastroenterology, at Tel Aviv University's Sackler Faculty of Medicine. "Generally speaking, it's much harder to get these people to comply with taking the test."
To convince more people to undergo the potentially life-saving colonoscopy, Prof. Arber has developed a simple early-warning test that can detect colon cancer in the blood. Using biomarkers, it is the first test on the market that can detect cells of colon polyps - the precursors to colon cancer - in the blood, with a very high degree of sensitivity and accuracy.
This painless, non-invasive and inexpensive test could very well be a breakthrough of the decade.
An Attractive Diagnostic Step
"If we can identify those who are prone to cancer through a less invasive test, we can convince them to do the colonoscopy," leading to earlier detection and treatment, says Prof. Arber, who heads the Integrated Cancer Prevention Center at the Tel Aviv Souraski Medical Center.
Now being prepared for the market by Bio Mark Ltd., a subsidiary of Micromedic Technologies Ltd., Prof. Arber's "CD24" test could begin to save thousands of Americans' lives by as early as 2010. With the test, doctors can catch polyp growth in the colon in 80% of patients.
The American Cancer Society suggests that all Americans over the age of 50 receive periodic colonoscopies. With Prof. Arber's test, doctors will be able to screen patients for colon cancer quickly and easily as part of a routine blood test. While not 100% accurate, it will provide a convincing argument for patients to undergo the colonoscopy, and then polyp removal, if necessary.
The novel invention is based on testing CD24, the oncogene for colorectal cancer. It utilizes the fact that polyps in the colon emit biomarkers, which can be detected in the blood at very low levels. Recent studies show that the test can correctly identify adenomas, the polyps that convert to colon cancer, at a success rate of more than 80%.
Some patients forego colonoscopy not just out of fear or distaste, but due to its high cost. Here, too, the breakthrough is significant. While traditional colonoscopies cost about about $1,500 per test, Prof. Arber's procedure is expected to cost much less - $50 to $100 per test.
Prevention Is Still the Best Medicine
Prof. Arber recommends a number of preventative steps against colon cancer, especially by those at risk. "There are some lifestyle choices people can make to prevent malignancies," he says. "Eating well, exercise, and avoiding smoking and drinking are very important."
Prof. Arber is also working on a drug that prevents the growth of polyps in the colon.
American Friends of Tel Aviv University (aftau/) supports Israel's largest and most comprehensive center of higher learning. It is ranked among the world's top 100 universities in science, biomedical studies, and social science, and rated one of the world's top 200 universities overall. Internationally recognized for the scope and groundbreaking nature of its research programs, Tel Aviv University consistently produces work with profound implications for the future.
Source: George Hunka
American Friends of Tel Aviv University
"85% of those who develop colon cancer have no symptoms or family history," says Prof. Nadir Arber, a professor of medicine and gastroenterology, at Tel Aviv University's Sackler Faculty of Medicine. "Generally speaking, it's much harder to get these people to comply with taking the test."
To convince more people to undergo the potentially life-saving colonoscopy, Prof. Arber has developed a simple early-warning test that can detect colon cancer in the blood. Using biomarkers, it is the first test on the market that can detect cells of colon polyps - the precursors to colon cancer - in the blood, with a very high degree of sensitivity and accuracy.
This painless, non-invasive and inexpensive test could very well be a breakthrough of the decade.
An Attractive Diagnostic Step
"If we can identify those who are prone to cancer through a less invasive test, we can convince them to do the colonoscopy," leading to earlier detection and treatment, says Prof. Arber, who heads the Integrated Cancer Prevention Center at the Tel Aviv Souraski Medical Center.
Now being prepared for the market by Bio Mark Ltd., a subsidiary of Micromedic Technologies Ltd., Prof. Arber's "CD24" test could begin to save thousands of Americans' lives by as early as 2010. With the test, doctors can catch polyp growth in the colon in 80% of patients.
The American Cancer Society suggests that all Americans over the age of 50 receive periodic colonoscopies. With Prof. Arber's test, doctors will be able to screen patients for colon cancer quickly and easily as part of a routine blood test. While not 100% accurate, it will provide a convincing argument for patients to undergo the colonoscopy, and then polyp removal, if necessary.
The novel invention is based on testing CD24, the oncogene for colorectal cancer. It utilizes the fact that polyps in the colon emit biomarkers, which can be detected in the blood at very low levels. Recent studies show that the test can correctly identify adenomas, the polyps that convert to colon cancer, at a success rate of more than 80%.
Some patients forego colonoscopy not just out of fear or distaste, but due to its high cost. Here, too, the breakthrough is significant. While traditional colonoscopies cost about about $1,500 per test, Prof. Arber's procedure is expected to cost much less - $50 to $100 per test.
Prevention Is Still the Best Medicine
Prof. Arber recommends a number of preventative steps against colon cancer, especially by those at risk. "There are some lifestyle choices people can make to prevent malignancies," he says. "Eating well, exercise, and avoiding smoking and drinking are very important."
Prof. Arber is also working on a drug that prevents the growth of polyps in the colon.
American Friends of Tel Aviv University (aftau/) supports Israel's largest and most comprehensive center of higher learning. It is ranked among the world's top 100 universities in science, biomedical studies, and social science, and rated one of the world's top 200 universities overall. Internationally recognized for the scope and groundbreaking nature of its research programs, Tel Aviv University consistently produces work with profound implications for the future.
Source: George Hunka
American Friends of Tel Aviv University
четверг, 2 июня 2011 г.
Positive Clinical Data For PBI-1402 Presented At The Annual Congress Of The European Hematology Association
ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") presented results on its orally-active PBI-1402 compound in clinical trial in patients with chemotherapy-induced anemia ("CIA") at the 13th Congress of the European Hematology Association held in Copenhagen, Denmark this week.
Dr. Lyne Gagnon, ProMetic's Director R&D, Biology, presented data on PBI-1402 in a poster entitled "PBI-1402 increases hemoglobin level and red blood cell count in chemotherapy-induced anemia". Results demonstrated that a once daily oral treatment of PBI-1402 induces a significant increase in hemoglobin ("Hb") level, red blood cell ("RBC") count and hematocrit ("Ht") in CIA patients. Furthermore, results suggest that PBI-1402 can reduce the need for RBC transfusion, since only 6% of patients in the clinical trial required transfusion.
"Subsequent positive data compiled from the 28 patients having completed the PBI-1402 CIA clinical trial include the fact that 26 of these patients did not require RBC transfusions while maintaining their full chemotherapy regimen. This data further supports that PBI-1402's current performance is in line with the Food and Drug Administration's ("FDA") recommendation of reducing patient need for RBC transfusions," states Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. "Additionally, PBI-1402 offers the added advantage of oral dosing which allows for a convenient management of anemia without interference with other treatments received by the CIA patients."
In the March 13, 2008 briefing document, the FDA's Oncologic Drugs Advisory Committee emphasized that the primary objective of treating CIA patients with erythropoiesis-stimulating agents ("ESAs") as being the ability to reduce the need for RBC transfusions. Approximately 50% of anemic patients receiving chemotherapy require RBC transfusions, and 20%-25% of patients treated with ESAs still require RBC transfusions.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the US, Europe, Asia and in the Middle-East.
prometic
Forward Looking Statements
This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 21 of ProMetic's Annual Information Form for the year ended December 31, 2007, under the heading "Risk Factors". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
ProMetic Life Sciences Inc.
Dr. Lyne Gagnon, ProMetic's Director R&D, Biology, presented data on PBI-1402 in a poster entitled "PBI-1402 increases hemoglobin level and red blood cell count in chemotherapy-induced anemia". Results demonstrated that a once daily oral treatment of PBI-1402 induces a significant increase in hemoglobin ("Hb") level, red blood cell ("RBC") count and hematocrit ("Ht") in CIA patients. Furthermore, results suggest that PBI-1402 can reduce the need for RBC transfusion, since only 6% of patients in the clinical trial required transfusion.
"Subsequent positive data compiled from the 28 patients having completed the PBI-1402 CIA clinical trial include the fact that 26 of these patients did not require RBC transfusions while maintaining their full chemotherapy regimen. This data further supports that PBI-1402's current performance is in line with the Food and Drug Administration's ("FDA") recommendation of reducing patient need for RBC transfusions," states Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. "Additionally, PBI-1402 offers the added advantage of oral dosing which allows for a convenient management of anemia without interference with other treatments received by the CIA patients."
In the March 13, 2008 briefing document, the FDA's Oncologic Drugs Advisory Committee emphasized that the primary objective of treating CIA patients with erythropoiesis-stimulating agents ("ESAs") as being the ability to reduce the need for RBC transfusions. Approximately 50% of anemic patients receiving chemotherapy require RBC transfusions, and 20%-25% of patients treated with ESAs still require RBC transfusions.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the US, Europe, Asia and in the Middle-East.
prometic
Forward Looking Statements
This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 21 of ProMetic's Annual Information Form for the year ended December 31, 2007, under the heading "Risk Factors". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
ProMetic Life Sciences Inc.
среда, 1 июня 2011 г.
Patient Organisations Welcome Revised NICE Recommendation To Approve Velcade For Myeloma, UK
Patient organisations Myeloma UK, Cancerbackup and Leukaemia CARE have welcomed the news that the National Institute for Health and Clinical Excellence (NICE) has issued revised preliminary positive guidance recommending that Velcade is made available on the NHS to patients living with the bone marrow cancer myeloma.
The patient organisations, who last year appealed against NICE's initial negative decision, today welcomed this draft recommendation as a positive step in the right direction for patients but wish to consider the details of the proposal carefully to ensure that the guidance represents the best deal for all patients.
"We very much welcome the fact that NICE has agreed that this important drug should be made available to myeloma patients, as it is without question clinically effective" says Eric Low, Chief Executive of Myeloma UK. "We understand that this draft recommendation has been reached after talks between NICE, the Department of Health and the manufacturer in which a 'response scheme' has been proposed, where the manufacturer rebates PCTs for patients that don't respond to Velcade. We welcome the fact that these conversations have resulted in a creative way to ensure that this important cancer drug can be made available to patients.
"However, we now need to carefully consider the details of the draft recommendation as we have concerns that it may exclude some patients who could benefit. We will be seeking clarification on the proposed guidance throughout the open consultation process and hope it will ensure that all patients who could benefit from the treatment can get access to it. We strongly believe that no patient should die without having had appropriate access to Velcade."
Judy Dewinter, Chairman of Myeloma UK and a myeloma patient reinforced this view, saying:
"Patients around the country, including myself, are incredibly relieved that the ruling is a move in the right direction. It has been a long time coming, with many families suffering anguish because they have not been able to access the treatment. This represents a major development and gives patients hope that they are one step closer to being able to access an important treatment to help them fight this complex and challenging disease."
This recommendation is now open to public consultation for the next two weeks before a final decision is issued by NICE in July.
Myeloma
-- Myeloma is a debilitating form of bone marrow cancer, which is currently incurable, but treatable
-- It is a cancer of the plasma cells, which are found in the bone marrow. Most symptoms are caused by build up of defective plasma cells in the marrow, these include: bone pain, bone fractures, fatigue, anaemia and an increased burden of infections
-- The incidence of myeloma is increasing faster than any other cancer in the Western world. It has increased by 30% over the past 30 years
-- It is more common than all but one form of leukaemia
-- Nearly 4,000 people in the UK are diagnosed with myeloma each year and there are 20,000 myeloma patients in the UK at any one time.
-- Until recently, the average life expectancy of a newly-diagnosed myeloma patient is 3-5 years, but new treatment advances means that people are living longer and it is hoped that myeloma will one day become a chronic, rather than incurable disease
-- Treatment in myeloma is aimed at halting the progress of disease and treating the symptoms of the disease to maintain and improve the patient's quality of life
-- The most common forms of treatment include chemotherapy, radiotherapy, steroids, stem cell transplants, thalidomide and new treatments such as Velcade
-- Originally considered an older person's disease, the incidence of myeloma is now increasing in the young, with 10-15% of patients now under the age of 55
myeloma.uk
cancerbackup
leukaemiacare.uk
View drug information on Velcade.
The patient organisations, who last year appealed against NICE's initial negative decision, today welcomed this draft recommendation as a positive step in the right direction for patients but wish to consider the details of the proposal carefully to ensure that the guidance represents the best deal for all patients.
"We very much welcome the fact that NICE has agreed that this important drug should be made available to myeloma patients, as it is without question clinically effective" says Eric Low, Chief Executive of Myeloma UK. "We understand that this draft recommendation has been reached after talks between NICE, the Department of Health and the manufacturer in which a 'response scheme' has been proposed, where the manufacturer rebates PCTs for patients that don't respond to Velcade. We welcome the fact that these conversations have resulted in a creative way to ensure that this important cancer drug can be made available to patients.
"However, we now need to carefully consider the details of the draft recommendation as we have concerns that it may exclude some patients who could benefit. We will be seeking clarification on the proposed guidance throughout the open consultation process and hope it will ensure that all patients who could benefit from the treatment can get access to it. We strongly believe that no patient should die without having had appropriate access to Velcade."
Judy Dewinter, Chairman of Myeloma UK and a myeloma patient reinforced this view, saying:
"Patients around the country, including myself, are incredibly relieved that the ruling is a move in the right direction. It has been a long time coming, with many families suffering anguish because they have not been able to access the treatment. This represents a major development and gives patients hope that they are one step closer to being able to access an important treatment to help them fight this complex and challenging disease."
This recommendation is now open to public consultation for the next two weeks before a final decision is issued by NICE in July.
Myeloma
-- Myeloma is a debilitating form of bone marrow cancer, which is currently incurable, but treatable
-- It is a cancer of the plasma cells, which are found in the bone marrow. Most symptoms are caused by build up of defective plasma cells in the marrow, these include: bone pain, bone fractures, fatigue, anaemia and an increased burden of infections
-- The incidence of myeloma is increasing faster than any other cancer in the Western world. It has increased by 30% over the past 30 years
-- It is more common than all but one form of leukaemia
-- Nearly 4,000 people in the UK are diagnosed with myeloma each year and there are 20,000 myeloma patients in the UK at any one time.
-- Until recently, the average life expectancy of a newly-diagnosed myeloma patient is 3-5 years, but new treatment advances means that people are living longer and it is hoped that myeloma will one day become a chronic, rather than incurable disease
-- Treatment in myeloma is aimed at halting the progress of disease and treating the symptoms of the disease to maintain and improve the patient's quality of life
-- The most common forms of treatment include chemotherapy, radiotherapy, steroids, stem cell transplants, thalidomide and new treatments such as Velcade
-- Originally considered an older person's disease, the incidence of myeloma is now increasing in the young, with 10-15% of patients now under the age of 55
myeloma.uk
cancerbackup
leukaemiacare.uk
View drug information on Velcade.
вторник, 31 мая 2011 г.
Most States Unclear About Storage, Use Of Babies' Blood Samples
State laws and policies governing the storage and use of surplus blood samples taken from newborns as part of the routine health screening process range from explicit to non-existent, leaving many parents ill-informed about how their babies' left over blood might be used, according to a team led by a member of the Johns Hopkins Berman Institute of Bioethics, in collaboration with researchers from the University of Utah. A report on their analysis of the subject is published March 28 in the journal Pediatrics.
The study is believed to be one of the first to provide in-depth analysis of the nation's fragmented newborn screening blood use policies. The authors say that their findings underscore the need for a comprehensive and transparent approach. At a minimum, all states should require that parents be fully informed about how babies' blood samples left over after the screening procedure will be stored and how they might be used, according to Michelle H. Lewis, M.D., J.D., a research scholar at the Berman Institute's Genetics and Public Policy Center.
The residual samples, typically dried blood spots, have been the center of public debate in recent years. In 2009, families in Minnesota and Texas sued their respective state health departments for storing surplus newborn blood samples without their knowledge or consent. News stories about the outrage expressed by parents-who claimed the practice violated their right to genetic privacy and full disclosure-spawned headlines such as CNN's: "The government has your baby's DNA."
"States have developed a wide range of policies regarding the retention and use of residual dried blood samples," says Lewis, "ranging from prohibiting their use for research under any circumstances, to allowing research with anonymous samples without parental consent, to requiring parental consent for any research using the samples."
Newborns in all 50 states, plus the District of Columbia, are routinely screened for a variety of genetic disorders, including phenylketonuria (pku) and sickle cell disease. State newborn screening programs began in the 1960s, and today, nearly all of the 4 million babies born each year in the United States undergo the procedure.
Once the screening has been completed, a small amount of dried blood often remains. This residual blood is often used for quality-assurance purposes to improve the operation of state newborn screening programs. Sometimes, the samples are also used for other types of biomedical research, including research unrelated to newborn screening.
Yet, state law in only 13 states specifies how residual samples of infant blood might be used. But these purposes often are often stated in broad language, according to Lewis and her co-authors. Among the detailed findings the researchers reported:
- Laws in 20 states address the retention and/or use of babies' blood samples.
- In 18 states, newborn screening laws fail to address the retention or use of the samples or their related information.
- Information related to newborn screening is deemed confidential in 26 states although limitations on that protection vary.
- Ten states specify the purposes for which information from the newborn blood samples may be used, such as public-health purposes, scientific research and research concerning medical, psychological or sociological issues.
- In four states, the samples become state property; in two of these states, parents can object in writing.
- Only eight states require that parents be provided information regarding the retention of newborn blood samples.
Overall, most states lack any requirement that parents be informed that their child's blood samples may be retained for future use, the researchers found. This was the problem in Texas, which settled out of court with the suing families last year. As part of the settlement agreement, the state Department of Health agreed to destroy more than 5 million samples that dated back to 2002, and a valuable research resource was lost.
"The destruction of those residual samples demonstrates the damage that can be done to the research enterprise if there is a public perception that states are using the samples for purposes other than that for which they were collected," Lewis says.
"I think some of the parents involved would have consented to the use of their baby's dried blood samples for research if they had been asked. These parents felt that their rights had been violated by not having been asked," Lewis added. "Even if the state did not intend to deceive the parents, there was a perception that the state was being deceptive, and this perception was damaging to the research enterprise."
The researchers agree that public discussion about the storage and use of newborn blood samples is vital, because people are becoming ever more aware that such specimens contain precise, identifying information about their children. People also realize that research is increasingly able to yield valuable information from biological specimens.
"Part of the issue is that some parents are concerned that the state or private companies could profit from the use of their children's blood sample," Lewis says.
Although no state addresses all of these issues in a comprehensive manner, Lewis pointed to South Carolina as one that had more robust policies in place with respect to the information that must be provided to parents. There, state law requires that parents be told that they can ask that their babies' blood samples not be used for research purposes.
"As states move forward in consideration of these issues," Lewis concluded, "it is vital that state policies regarding the retention and use of residual samples not undermine the public's trust in state newborn screening programs-so that these programs can continue to protect the health of our nation's children."
In addition to Lewis, the paper was co-authored by Jeffrey Botkin, a professor of pediatrics at the University of Utah; Aaron Goldenberg, an assistant professor of bioethics at Case Western Reserve University; Rebecca Anderson, a medical ethics researcher at the University of Utah's Department of Pediatrics; and Erin Rothwell, an assistant professor at the University of Utah's School of Nursing and a fellow in the Bioethics Program at the Medical College of Wisconsin.
Their study was funded by a grant from the National Institutes of Health to the University of Utah, titled "Methods for Promoting Public Dialogue on the Use of Residual Newborn Screening Samples for Research."
Source:
Johns Hopkins Medicine
The study is believed to be one of the first to provide in-depth analysis of the nation's fragmented newborn screening blood use policies. The authors say that their findings underscore the need for a comprehensive and transparent approach. At a minimum, all states should require that parents be fully informed about how babies' blood samples left over after the screening procedure will be stored and how they might be used, according to Michelle H. Lewis, M.D., J.D., a research scholar at the Berman Institute's Genetics and Public Policy Center.
The residual samples, typically dried blood spots, have been the center of public debate in recent years. In 2009, families in Minnesota and Texas sued their respective state health departments for storing surplus newborn blood samples without their knowledge or consent. News stories about the outrage expressed by parents-who claimed the practice violated their right to genetic privacy and full disclosure-spawned headlines such as CNN's: "The government has your baby's DNA."
"States have developed a wide range of policies regarding the retention and use of residual dried blood samples," says Lewis, "ranging from prohibiting their use for research under any circumstances, to allowing research with anonymous samples without parental consent, to requiring parental consent for any research using the samples."
Newborns in all 50 states, plus the District of Columbia, are routinely screened for a variety of genetic disorders, including phenylketonuria (pku) and sickle cell disease. State newborn screening programs began in the 1960s, and today, nearly all of the 4 million babies born each year in the United States undergo the procedure.
Once the screening has been completed, a small amount of dried blood often remains. This residual blood is often used for quality-assurance purposes to improve the operation of state newborn screening programs. Sometimes, the samples are also used for other types of biomedical research, including research unrelated to newborn screening.
Yet, state law in only 13 states specifies how residual samples of infant blood might be used. But these purposes often are often stated in broad language, according to Lewis and her co-authors. Among the detailed findings the researchers reported:
- Laws in 20 states address the retention and/or use of babies' blood samples.
- In 18 states, newborn screening laws fail to address the retention or use of the samples or their related information.
- Information related to newborn screening is deemed confidential in 26 states although limitations on that protection vary.
- Ten states specify the purposes for which information from the newborn blood samples may be used, such as public-health purposes, scientific research and research concerning medical, psychological or sociological issues.
- In four states, the samples become state property; in two of these states, parents can object in writing.
- Only eight states require that parents be provided information regarding the retention of newborn blood samples.
Overall, most states lack any requirement that parents be informed that their child's blood samples may be retained for future use, the researchers found. This was the problem in Texas, which settled out of court with the suing families last year. As part of the settlement agreement, the state Department of Health agreed to destroy more than 5 million samples that dated back to 2002, and a valuable research resource was lost.
"The destruction of those residual samples demonstrates the damage that can be done to the research enterprise if there is a public perception that states are using the samples for purposes other than that for which they were collected," Lewis says.
"I think some of the parents involved would have consented to the use of their baby's dried blood samples for research if they had been asked. These parents felt that their rights had been violated by not having been asked," Lewis added. "Even if the state did not intend to deceive the parents, there was a perception that the state was being deceptive, and this perception was damaging to the research enterprise."
The researchers agree that public discussion about the storage and use of newborn blood samples is vital, because people are becoming ever more aware that such specimens contain precise, identifying information about their children. People also realize that research is increasingly able to yield valuable information from biological specimens.
"Part of the issue is that some parents are concerned that the state or private companies could profit from the use of their children's blood sample," Lewis says.
Although no state addresses all of these issues in a comprehensive manner, Lewis pointed to South Carolina as one that had more robust policies in place with respect to the information that must be provided to parents. There, state law requires that parents be told that they can ask that their babies' blood samples not be used for research purposes.
"As states move forward in consideration of these issues," Lewis concluded, "it is vital that state policies regarding the retention and use of residual samples not undermine the public's trust in state newborn screening programs-so that these programs can continue to protect the health of our nation's children."
In addition to Lewis, the paper was co-authored by Jeffrey Botkin, a professor of pediatrics at the University of Utah; Aaron Goldenberg, an assistant professor of bioethics at Case Western Reserve University; Rebecca Anderson, a medical ethics researcher at the University of Utah's Department of Pediatrics; and Erin Rothwell, an assistant professor at the University of Utah's School of Nursing and a fellow in the Bioethics Program at the Medical College of Wisconsin.
Their study was funded by a grant from the National Institutes of Health to the University of Utah, titled "Methods for Promoting Public Dialogue on the Use of Residual Newborn Screening Samples for Research."
Source:
Johns Hopkins Medicine
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