German scientists have identified a serious and previously misunderstood contaminant that brings the safety and efficacy of intravenous treatments into question. In a report published in the September 2009 issue of the Journal of Leukocyte Biology, they show how a common intravenous treatment used to boost blood pressure in ailing patients also contains substances called "advanced glycation end products," which trigger inflammation. These substances result from reactions that occur among the various proteins (called "posttranslational modification") within the intravenous fluid after it has been formulated for use. This study directly challenges today's prevalent belief that advanced glycation end products are not contaminants.
"Improving the quality of infusion solutions by accounting for posttranslational modification of proteins could lead to better clinical outcomes for patients, such as those treated solutions containing albumin," said Angelika Bierhaus, senior scientist and co-study author from the University of Heidelberg in Germany.
To make their discovery, Bierhaus and colleagues detected advanced glycation end products in several currently available albumin infusion solutions and injected separate groups of mice with solutions containing both high and low amounts of this substance. The mice receiving the high levels of advanced glycation end products experienced significantly higher inflammation and death rates than the mice receiving solutions with low levels of advanced glycation end products. This suggests that screening infusion solutions for posttranslational protein modifications and then removing the compounds may improve patient outcomes, especially treatments requiring albumin infusions.
"It is always difficult to learn that what was once thought safe might have more risk than previously appreciated, especially when it relates to treatments meant to save lives," said John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology. "This discovery, however, should allow manufacturers to improve the quality, tolerability and safety of a number of clinical products."
Source:
Cody Mooneyhan
Federation of American Societies for Experimental Biology
воскресенье, 12 июня 2011 г.
суббота, 11 июня 2011 г.
Malaria Fight Proceeds With Blood-Thinning Copycat
New treatments for malaria are possible after Walter and Eliza Hall Institute scientists found that molecules similar to the blood-thinning drug heparin can stop malaria from infecting red blood cells.
Malaria is an infection of red blood cells that is transmitted by mosquitoes. The most common form of malaria is caused by the parasite Plasmodium falciparum which burrows into red blood cells where it rapidly multiplies, leading to massive numbers of parasites in the blood stream that can cause severe disease and death.
At the moment, all anti-malarials licensed for use in humans block the development of the parasite within the red blood cell.
But Dr James Beeson, Ms Michelle Boyle and Dr Jack Richards from the institute's Infection and Immunity division, along with colleagues at the Burnet Institute and Imperial College London, have identified a new approach that could stop the parasite infecting red blood cells in the first place.
Using real-time video microscopy of red blood cell infection, the team showed that heparin-like carbohydrates blocked the ability of the malaria parasite to infect cells, Dr Beeson said.
"The malaria parasite needs a protein called MSP1 if it is to infect red blood cells as MSP1 is involved in the initial attachment of the parasite to the cells," Dr Beeson said.
"We have shown that heparin-like carbohydrates bind to MSP1 which stops the parasite from properly attaching to the red blood cell and, therefore, from invading."
The findings are published in the international journal Blood and have raised the prospect of developing new anti-malarials that are based on the structure and activity of heparin-like molecules.
Although humans produce heparin-like molecules naturally, they do not occur at high enough levels in the blood to have anti-malarial activity, Dr Beeson said. "Heparin itself wouldn't be suitable as an anti-malarial as it prevents blood clotting. However, we have identified related compounds that are more potent against malaria than heparin but do not prevent blood clotting - these could form the basis of new antimalarial drugs."
Each year more than 400 million people contract malaria, and around one million people, mostly children, die from the disease.
This research was supported by the National Health and Medical Research Council and the Victorian and Commonwealth governments.
Source:
Penny Fannin
Walter and Eliza Hall Institute
Malaria is an infection of red blood cells that is transmitted by mosquitoes. The most common form of malaria is caused by the parasite Plasmodium falciparum which burrows into red blood cells where it rapidly multiplies, leading to massive numbers of parasites in the blood stream that can cause severe disease and death.
At the moment, all anti-malarials licensed for use in humans block the development of the parasite within the red blood cell.
But Dr James Beeson, Ms Michelle Boyle and Dr Jack Richards from the institute's Infection and Immunity division, along with colleagues at the Burnet Institute and Imperial College London, have identified a new approach that could stop the parasite infecting red blood cells in the first place.
Using real-time video microscopy of red blood cell infection, the team showed that heparin-like carbohydrates blocked the ability of the malaria parasite to infect cells, Dr Beeson said.
"The malaria parasite needs a protein called MSP1 if it is to infect red blood cells as MSP1 is involved in the initial attachment of the parasite to the cells," Dr Beeson said.
"We have shown that heparin-like carbohydrates bind to MSP1 which stops the parasite from properly attaching to the red blood cell and, therefore, from invading."
The findings are published in the international journal Blood and have raised the prospect of developing new anti-malarials that are based on the structure and activity of heparin-like molecules.
Although humans produce heparin-like molecules naturally, they do not occur at high enough levels in the blood to have anti-malarial activity, Dr Beeson said. "Heparin itself wouldn't be suitable as an anti-malarial as it prevents blood clotting. However, we have identified related compounds that are more potent against malaria than heparin but do not prevent blood clotting - these could form the basis of new antimalarial drugs."
Each year more than 400 million people contract malaria, and around one million people, mostly children, die from the disease.
This research was supported by the National Health and Medical Research Council and the Victorian and Commonwealth governments.
Source:
Penny Fannin
Walter and Eliza Hall Institute
пятница, 10 июня 2011 г.
Phase III Data Published On The Effect Of 'Tredaptive' (nicotinic Acid /laropiprant) Combined With Simvastatin On LDL-C, HDL-C And Triglyceride Levels
Results from a phase III clinical study published in the latest issue of British Journal of Cardiology showed that patients with primary hypercholesterolaemia or mixed dyslipidaemia) when treated with 2 g 'Tredaptive' (nicotinic acid/ laropiprant) co-administered with simvastatin (pooled across 20 mg or 40 mg doses) (n= 609), experienced reduced LDL-C by nearly 48%, increased HDL-C by nearly 28%, and reduced triglyceride levels by approximately 33% following 12 weeks of treatment.1
The primary study endpoint was change in LDL-C levels in patients treated with 2 g 'Tredaptive' co-administered with simvastatin compared to those treated with 2 g of the drug alone. Secondary endpoints included change in LDL-C, HDL-C, and triglyceride levels in patients treated with 2 g of the drug and simvastatin (pooled) compared to those treated with simvastatin alone.1
In the other treatment arms, 2 g 'Tredaptive' alone (n = 192) reduced LDL-C by 17%, increased HDL-C by approximately 23%, and reduced triglycerides by nearly 22%; and simvastatin alone (pooled) (n = 585) reduced LDL-C by 37%, increased HDL-C by 6%, and reduced triglycerides by nearly 15%.1 Comparative lipid efficacy results were measured as mean percent change from baseline for LDL-C and HDL-C, and median percent change for triglycerides.1
"The results in this study suggest that nicotinic acid / laropiprant, used with a statin, could offer another approach to treat patients with dyslipidaemia," said Christie M. Ballantyne, M.D., associate chief and professor of medicine, Baylor College of Medicine, and co-author of the study.
High LDL-C, low HDL-C and elevated triglycerides are all risk factors associated with heart attacks and strokes.2,3,4
-
Prescribing information
For full prescribing information of 'Tredaptive', please refer to the Summary of Product Characteristics (SPC) included in this email. If the SPC is missing, please contact any of the individuals listed at the start of this release for a copy.
About the study
The double-blind, parallel, 12-week study with seven treatment arms in almost
1,400 patients evaluated treatment with an initial 1g of 'Tredaptive' (1g modified-release nicotinic acid/20mg laropiprant) co-administered with simvastatin 10mg to 40mg in weeks one through four which was increased to a 2 g dose (two tablets each containing 1 g modified-release nicotinic acid/20 mg of laropiprant) co-administered with simvastatin 20mg to 40 mg and maintained for weeks 5 through 12 (n = 590). Tolerability and the safety profile of the combination were also evaluated.
Cardiovascular disease
Cardiovascular disease (CVD) is a general term referring to diseases that affect the heart or blood vessels. Coronary heart disease (CHD), also known as coronary artery disease (CAD), is one of the most common forms of CVD and is the leading cause of death globally.5 Major risk factors for CVD include abnormal blood lipids, meaning not only high LDL-C but also high levels of triglycerides and low levels of HDL-C.6,7
CVD is one of the main causes of death in Europe, accounting for over 4.3 million deaths (48% of all mortality).8 It is also the UK's number one killer with more than one in three people dying from cardiovascular disease.9 Coronary Heart Disease by itself is the most common cause of death in the U.K. accounting for 101,000 deaths per year.9
About Merck Sharp & Dohme
Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.
Forward-Looking Statement
This press release contains "forward-looking statements" about product development, product potential or about financial performance based on current expectations of the management of Merck & Co., Inc. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
References
1. Gleim G, Ballantyne C, Liu N et al. Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia. Br J Cardiol 2009;16:90-7
2. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) - 5 - Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:2486-2497
3. Nordestgaard BG, Benn M, Schnohr P et al. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007;298:299-308
4. Kannel WB. Status of risk factors and their consideration in antihypertensive therapy. Am J Cardiol. 1987;59:80ВЄ-90A
5. World Health Organization. The Top 10 causes of death factsheet. November 2008 who.int/mediacentre/factsheets/fs310_2008.pdf [Access on 24.03.09]
6. Heart UK, 'Risk factors for CHD' factsheet, heartuk.uk/images/uploads/healthylivingpdfs/HUKcfs_I_Risk_Factors.pdf [Access on 24.03.09]
7. Department of Health, Health Survey for England 2003, Volume 2, 'Risk factors for cardiovascular disease
8. European Heart Network. European Cardiovascular disease statistics 2008 edition
9. Allender S, Peto V, Scarborough P, et al. Coronary heart disease statistics 2007, Chapter 1. British Heart Foundation, London
Source
Merck Sharp & Dohme
The primary study endpoint was change in LDL-C levels in patients treated with 2 g 'Tredaptive' co-administered with simvastatin compared to those treated with 2 g of the drug alone. Secondary endpoints included change in LDL-C, HDL-C, and triglyceride levels in patients treated with 2 g of the drug and simvastatin (pooled) compared to those treated with simvastatin alone.1
In the other treatment arms, 2 g 'Tredaptive' alone (n = 192) reduced LDL-C by 17%, increased HDL-C by approximately 23%, and reduced triglycerides by nearly 22%; and simvastatin alone (pooled) (n = 585) reduced LDL-C by 37%, increased HDL-C by 6%, and reduced triglycerides by nearly 15%.1 Comparative lipid efficacy results were measured as mean percent change from baseline for LDL-C and HDL-C, and median percent change for triglycerides.1
"The results in this study suggest that nicotinic acid / laropiprant, used with a statin, could offer another approach to treat patients with dyslipidaemia," said Christie M. Ballantyne, M.D., associate chief and professor of medicine, Baylor College of Medicine, and co-author of the study.
High LDL-C, low HDL-C and elevated triglycerides are all risk factors associated with heart attacks and strokes.2,3,4
-
Prescribing information
For full prescribing information of 'Tredaptive', please refer to the Summary of Product Characteristics (SPC) included in this email. If the SPC is missing, please contact any of the individuals listed at the start of this release for a copy.
About the study
The double-blind, parallel, 12-week study with seven treatment arms in almost
1,400 patients evaluated treatment with an initial 1g of 'Tredaptive' (1g modified-release nicotinic acid/20mg laropiprant) co-administered with simvastatin 10mg to 40mg in weeks one through four which was increased to a 2 g dose (two tablets each containing 1 g modified-release nicotinic acid/20 mg of laropiprant) co-administered with simvastatin 20mg to 40 mg and maintained for weeks 5 through 12 (n = 590). Tolerability and the safety profile of the combination were also evaluated.
Cardiovascular disease
Cardiovascular disease (CVD) is a general term referring to diseases that affect the heart or blood vessels. Coronary heart disease (CHD), also known as coronary artery disease (CAD), is one of the most common forms of CVD and is the leading cause of death globally.5 Major risk factors for CVD include abnormal blood lipids, meaning not only high LDL-C but also high levels of triglycerides and low levels of HDL-C.6,7
CVD is one of the main causes of death in Europe, accounting for over 4.3 million deaths (48% of all mortality).8 It is also the UK's number one killer with more than one in three people dying from cardiovascular disease.9 Coronary Heart Disease by itself is the most common cause of death in the U.K. accounting for 101,000 deaths per year.9
About Merck Sharp & Dohme
Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.
Forward-Looking Statement
This press release contains "forward-looking statements" about product development, product potential or about financial performance based on current expectations of the management of Merck & Co., Inc. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
References
1. Gleim G, Ballantyne C, Liu N et al. Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia. Br J Cardiol 2009;16:90-7
2. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) - 5 - Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:2486-2497
3. Nordestgaard BG, Benn M, Schnohr P et al. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007;298:299-308
4. Kannel WB. Status of risk factors and their consideration in antihypertensive therapy. Am J Cardiol. 1987;59:80ВЄ-90A
5. World Health Organization. The Top 10 causes of death factsheet. November 2008 who.int/mediacentre/factsheets/fs310_2008.pdf [Access on 24.03.09]
6. Heart UK, 'Risk factors for CHD' factsheet, heartuk.uk/images/uploads/healthylivingpdfs/HUKcfs_I_Risk_Factors.pdf [Access on 24.03.09]
7. Department of Health, Health Survey for England 2003, Volume 2, 'Risk factors for cardiovascular disease
8. European Heart Network. European Cardiovascular disease statistics 2008 edition
9. Allender S, Peto V, Scarborough P, et al. Coronary heart disease statistics 2007, Chapter 1. British Heart Foundation, London
Source
Merck Sharp & Dohme
четверг, 9 июня 2011 г.
Blood Clotting Drug, ATryn, From Genetically Engineered Goats Approved By FDA
The FDA (Food and Drug Administration) has approved the first ever biological product produced by a genetically engineered animal - a goat. ATryn is an anticoagulant, used for the prevention of blood clots. It is for patients who have a rare disease known as AT (hereditary antithrombin) deficiency. Patients are at high risk of blood clots when they undergo medical intervention such as surgery, and during/before and after childbirth.
Derived from the milk of goats, ATryn is a therapeutic protein. The goats have been genetically engineered (GE) by introducing a segment of DNA into their genes (DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin occurs naturally in healthy humans - it helps keep blood from clotting in blood vessels.
GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.
Jesse Goodman, M.D., M.P.H., CBER director, said "This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations,"
As AT deficiency only occurs in 1 in every 5,000 people in the USA, the FDA granted ATryn an orphan drug destination - a system which encourages the development and delivery of drugs for very rare diseases and conditions. The FDA held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.
Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.
CBER looked at two studies involving 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which is likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.
As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor's plan to continue to monitor the construct and its expression for the lifetime of the approved product.
CVM determined that introduction of the rDNA construct did not cause any undesirable side effects to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products. CVM also determined that the GE goats do not cause any significant impact on the environment.
Bernadette Dunham, D.V.M., Ph.D., CVM director "We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven't seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication."
A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM's guidance on the regulation of GE animals containing heritable rDNA constructs are available here.
ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.
ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.
Source - FDA.
Written by -
View drug information on Atryn.
Derived from the milk of goats, ATryn is a therapeutic protein. The goats have been genetically engineered (GE) by introducing a segment of DNA into their genes (DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin occurs naturally in healthy humans - it helps keep blood from clotting in blood vessels.
GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.
Jesse Goodman, M.D., M.P.H., CBER director, said "This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations,"
As AT deficiency only occurs in 1 in every 5,000 people in the USA, the FDA granted ATryn an orphan drug destination - a system which encourages the development and delivery of drugs for very rare diseases and conditions. The FDA held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.
Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.
CBER looked at two studies involving 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which is likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.
As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor's plan to continue to monitor the construct and its expression for the lifetime of the approved product.
CVM determined that introduction of the rDNA construct did not cause any undesirable side effects to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products. CVM also determined that the GE goats do not cause any significant impact on the environment.
Bernadette Dunham, D.V.M., Ph.D., CVM director "We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven't seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication."
A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM's guidance on the regulation of GE animals containing heritable rDNA constructs are available here.
ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.
ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.
Source - FDA.
Written by -
View drug information on Atryn.
среда, 8 июня 2011 г.
ImmunoGen, Inc. Announces Encouraging Clinical Data With Its IMGN901 Compound In The Treatment Of Multiple Myeloma
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, reported encouraging clinical data with its IMGN901 product candidate in the treatment of relapsed and relapsed/refractory multiple myeloma (MM), including prolonged benefit in patients whose disease had progressed on multiple prior treatment regimens. These findings were reported at the American Society of Hematology (ASH) 51th Annual Meeting and Exposition being held in New Orleans, MA.
IMGN901 is an investigational agent designed to kill cancer cells that express CD56, a protein. It consists of a CD56-binding antibody with a potent cancer-cell killing agent, DM1, attached to it using an engineered linker. IMGN901 is in Phase I testing for the treatment of CD56-expressing solid tumors and multiple myeloma. It is wholly-owned by ImmunoGen.
In the trial reported today, new cohorts of patients received increasingly greater amounts of IMGN901 - used as a single agent - until the maximum tolerated dose was established. All of the patients had CD56-expressing MM that had progressed on multiple therapies, and most had previously been treated with at least six chemotherapy regimens.
"What was particularly impressive was the duration of benefit seen with IMGN901 in a number of these heavily pre-treated patients," commented Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute. "IMGN901 demonstrated encouraging activity as a single agent in a disease often treated with combination therapy, and the tolerability findings to date support evaluating it used together with other active agents."
Among the twenty-six patients treated with IMGN901 at any dose level:
- One patient had a partial response (PR) while receiving IMGN901. This patient has continued on treatment for more than a year.
- Three patients had a minimal response (MR) while receiving IMGN901, and two of these patients remained on treatment for at least 45 weeks. The third patient withdrew from the study due to a broken leg while continuing to show disease improvement.
- Eleven patients had stable disease (SD), with eight of these patients remaining on treatment for at least 12 weeks at the time of data cut-off for presentation. These include four patients who have received IMGN901 for at least 24 weeks and two other patients still undergoing treatment.
- The overall clinical benefit rate (objective responses plus sustained stable disease) was 46%.
Ten patients remained on IMGN901 longer than on regimens received earlier in the course of their disease, and eight of these patients were on IMGN901 longer than on their last regimen with approved therapies. Typically in the treatment of cancer, patients have their best treatment responses early in the course of their disease and respond less well to later therapies.
IMGN901 was found to be generally well tolerated and was not associated with significant myelosuppression or other side effects that would limit its ability to be administered in combination with other active agents. The most common side effects were mild-to-moderate headache, fatigue and neuropathy. Grade 3 fatigue was reported in two patients and was the only grade 3 side effect reported in more than one patient; no more severe (grade 4 or 5) side effects were associated with use of the agent. The maximum tolerated dose was established to be 112 mg/m2/week.
"This trial - Study 003 - has provided us with important information on the safety of IMGN901 when used alone to treat multiple myeloma that has progressed on numerous prior therapies," noted James O'Leary, MD, Vice President and Chief Medical Officer of ImmunoGen. "The expansion phase of this trial, which is now underway, provides for patients with less heavily pretreated multiple myeloma to receive IMGN901 at the maximum tolerated dose, enabling us to better assess its activity when used as a single agent."
Dr. O'Leary continued, "Multiple myeloma is often treated with a combination of therapies with different mechanisms of action. Thus, we feel it's important to also assess IMGN901 as part of a multi-agent regimen. The profile of IMGN901 suggests that it's particularly well suited to use in combination, as it works by a novel mechanism and has not been associated with side effects that would limit its ability to be used with other agents. We expect patient dosing in our Study 005 combination trial to begin shortly."
About the Presentation
The poster, "Phase I Study of IMGN901, Used as Monotherapy, in Patients with Heavily Pre-Treated CD56-Positive Multiple Myeloma - A Preliminary Safety and Efficacy Analysis" is being presented at ASH between 6:00 - 8:00 pm (CT). Dr. Chanan-Khan is the lead investigator in the study.
About Study 003
This Phase I trial evaluates IMGN901 in patients with CD56+ multiple myeloma that has progressed on prior treatments (relapsed disease) and may no longer respond to these agents (refractory disease). In Study 003, IMGN901 is administered weekly for two consecutive weeks every three weeks (one treatment cycle). During the dose-escalation portion of the trial, no limit was placed on the number of prior therapies a patient may have received. In the expansion phase now underway, patients must have received at least one but no more than three prior treatment regimens to be eligible for enrollment. In this leg of the trial, progression-free survival and overall survival data will be captured as well as objective response information.
Other IMGN901 Studies
Study 005 is a Phase I trial designed to evaluate IMGN901 in CD56+ multiple myeloma when used in combination with lenalidomide (Revlimid®) and dexamethasone. It is expected to start in late 2009. Study 002 evaluates IMGN901 in the treatment of CD56+ solid tumors, which include small-cell lung cancer, Merkel cell carcinoma and ovarian cancers. Patient enrollment is underway in the expansion portion of this trial.
Source
ImmunoGen, Inc.
View drug information on Revlimid.
IMGN901 is an investigational agent designed to kill cancer cells that express CD56, a protein. It consists of a CD56-binding antibody with a potent cancer-cell killing agent, DM1, attached to it using an engineered linker. IMGN901 is in Phase I testing for the treatment of CD56-expressing solid tumors and multiple myeloma. It is wholly-owned by ImmunoGen.
In the trial reported today, new cohorts of patients received increasingly greater amounts of IMGN901 - used as a single agent - until the maximum tolerated dose was established. All of the patients had CD56-expressing MM that had progressed on multiple therapies, and most had previously been treated with at least six chemotherapy regimens.
"What was particularly impressive was the duration of benefit seen with IMGN901 in a number of these heavily pre-treated patients," commented Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute. "IMGN901 demonstrated encouraging activity as a single agent in a disease often treated with combination therapy, and the tolerability findings to date support evaluating it used together with other active agents."
Among the twenty-six patients treated with IMGN901 at any dose level:
- One patient had a partial response (PR) while receiving IMGN901. This patient has continued on treatment for more than a year.
- Three patients had a minimal response (MR) while receiving IMGN901, and two of these patients remained on treatment for at least 45 weeks. The third patient withdrew from the study due to a broken leg while continuing to show disease improvement.
- Eleven patients had stable disease (SD), with eight of these patients remaining on treatment for at least 12 weeks at the time of data cut-off for presentation. These include four patients who have received IMGN901 for at least 24 weeks and two other patients still undergoing treatment.
- The overall clinical benefit rate (objective responses plus sustained stable disease) was 46%.
Ten patients remained on IMGN901 longer than on regimens received earlier in the course of their disease, and eight of these patients were on IMGN901 longer than on their last regimen with approved therapies. Typically in the treatment of cancer, patients have their best treatment responses early in the course of their disease and respond less well to later therapies.
IMGN901 was found to be generally well tolerated and was not associated with significant myelosuppression or other side effects that would limit its ability to be administered in combination with other active agents. The most common side effects were mild-to-moderate headache, fatigue and neuropathy. Grade 3 fatigue was reported in two patients and was the only grade 3 side effect reported in more than one patient; no more severe (grade 4 or 5) side effects were associated with use of the agent. The maximum tolerated dose was established to be 112 mg/m2/week.
"This trial - Study 003 - has provided us with important information on the safety of IMGN901 when used alone to treat multiple myeloma that has progressed on numerous prior therapies," noted James O'Leary, MD, Vice President and Chief Medical Officer of ImmunoGen. "The expansion phase of this trial, which is now underway, provides for patients with less heavily pretreated multiple myeloma to receive IMGN901 at the maximum tolerated dose, enabling us to better assess its activity when used as a single agent."
Dr. O'Leary continued, "Multiple myeloma is often treated with a combination of therapies with different mechanisms of action. Thus, we feel it's important to also assess IMGN901 as part of a multi-agent regimen. The profile of IMGN901 suggests that it's particularly well suited to use in combination, as it works by a novel mechanism and has not been associated with side effects that would limit its ability to be used with other agents. We expect patient dosing in our Study 005 combination trial to begin shortly."
About the Presentation
The poster, "Phase I Study of IMGN901, Used as Monotherapy, in Patients with Heavily Pre-Treated CD56-Positive Multiple Myeloma - A Preliminary Safety and Efficacy Analysis" is being presented at ASH between 6:00 - 8:00 pm (CT). Dr. Chanan-Khan is the lead investigator in the study.
About Study 003
This Phase I trial evaluates IMGN901 in patients with CD56+ multiple myeloma that has progressed on prior treatments (relapsed disease) and may no longer respond to these agents (refractory disease). In Study 003, IMGN901 is administered weekly for two consecutive weeks every three weeks (one treatment cycle). During the dose-escalation portion of the trial, no limit was placed on the number of prior therapies a patient may have received. In the expansion phase now underway, patients must have received at least one but no more than three prior treatment regimens to be eligible for enrollment. In this leg of the trial, progression-free survival and overall survival data will be captured as well as objective response information.
Other IMGN901 Studies
Study 005 is a Phase I trial designed to evaluate IMGN901 in CD56+ multiple myeloma when used in combination with lenalidomide (Revlimid®) and dexamethasone. It is expected to start in late 2009. Study 002 evaluates IMGN901 in the treatment of CD56+ solid tumors, which include small-cell lung cancer, Merkel cell carcinoma and ovarian cancers. Patient enrollment is underway in the expansion portion of this trial.
Source
ImmunoGen, Inc.
View drug information on Revlimid.
вторник, 7 июня 2011 г.
Immunomedics Reports New And Updated Clinical Results From Dose De-Escalation Study With HA20 In Lymphoma Patients
Immunomedics, Inc. (Nasdaq:
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies to treat cancer and other serious diseases, today announced that
Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de
Lille, Lille, France, presented data at the 43rd Annual Meeting of the
American Society of Clinical Oncology in Chicago, IL, showing the Company's
humanized anti-CD20 monoclonal antibody (hA20) was active in patients with
non-Hodgkin's lymphoma (NHL) at a low dose of 80 mg/m2.
Current biological therapy with monoclonal antibodies for NHL includes
rituximab, which has been approved at a dose of 375 mg/m2. Immunomedics'
hA20 displays similar binding characteristics and mechanisms of action as
rituximab. Constructed using the same human donor frameworks as the
Company's anti-CD22 antibody, epratuzumab, hA20 shows an excellent safety
and tolerability profile with shorter infusion times (less than 2 hours for
the first infusion and under 1 hour for subsequent infusions) compared to
rituximab. To-date, no patients have shown an elevated immune response to
repeated injections of hA20.
Seventy-eight adult patients with CD20-positive B-cell NHL have now
been enrolled in this open-label, multi-center Phase I/II study. hA20 was
administered once weekly for four consecutive weeks at 5 dose levels: 80,
120, 200, 375, or 750 mg/m2. Treatment responses from 56 assessable
patients (38 with follicular lymphoma and 18 with non-follicular lymphoma)
with at least one post-treatment evaluation were reported at the meeting.
The overall objective response rate (partial and complete responses) was
45% (25/56), with 20% (11/56) of patients having a complete response
(CR/CRu).
In the 38 patients with follicular lymphoma, the overall response rate
was 47% (18/38), with a complete response rate of 24% (9/38). In
non-follicular lymphomas, the overall responses rate was 39% (7/18), with a
complete response rate of 11% (2/18). In a median follow-up of 8 months
post therapy, 12/25 (48%) had continuing responses, including 5 with
long-lived responses (15-24 months). At the lowest dose of 80 mg/m2, B-cell
depletion occurred after the first infusion, and 2 patients had complete
response. One in the follicular lymphoma group and the other patient had
marginal zone lymphoma. Other data are being evaluated at this low dose
with more patients accruing.
This study was extended to focus on confirming the efficacy of lower
doses at 80 and 120 mg/m2. The results confirmed that complete responses
and B-cell depletion occurred at all five doses.
"We believe the low dose allows us to develop a subcutaneous
formulation for hA20 with the goal of offering patients the benefits of
ease of use with less side effects," commented Cynthia L. Sullivan,
President and CEO of Immunomedics. "While we continue to discuss
out-licensing this product with potential partners, we plan to initiate a
study in NHL patients with the new subcutaneous formulation and to advance
the development of this humanized CD20 antibody in an autoimmune disease
using the existing intravenous formulation before the end of this calendar
year," She further remarked.
In the United States, NHL is the most common form of blood cancer,
affecting over 380,000 people. In 2007, there are approximately 63,190 new
cases and almost 18,660 deaths from this disease in the United States.
About hA20
hA20 was constructed using the same human donor frameworks and methods
employed to make the Company's anti-CD22 antibody, epratuzumab. Epratuzumab
has been studied in over 300 non-Hodgkin's lymphoma (NHL) patients and can
be infused within an hour. hA20 displays similar binding avidity,
specificity, and mechanisms of action as rituximab, but has structural
differences, and to- date shows an excellent safety and tolerability
profile, even when infused within 2 hours. At a single low dose of 80
mg/m2, hA20 depleted circulatory B-cells, and when given once weekly for 4
consecutive weeks, produced complete responses in NHL patients. Doses
between 80 and 750 mg/m2 were evaluated in this multi-center clinical
trial. To-date, no patients have shown an elevated immune response to
repeated injections of hA20.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have
developed a number of advanced proprietary technologies that allow us to
create humanized antibodies that can be used either alone in unlabeled or
"naked" form, or conjugated with radioactive isotopes, chemotherapeutics or
toxins, in each case to create highly targeted agents. Using these
technologies, we have built a pipeline of therapeutic product candidates
that utilize several different mechanisms of action. We have licensed our
lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all
autoimmune disease indications worldwide. We have retained the rights for
epratuzumab in oncology indications for which UCB has been granted a buy-in
option. UCB has development, manufacture and commercialization rights, and
is responsible for all clinical trials evaluating epratuzumab for the
treatment of patients with moderate and severe lupus. At present, there is
no cure for lupus and no new lupus drug has been approved in the U.S. in
the last 40 years. The Company is conducting clinical trials with hA20 in
patients with non-Hodgkin's lymphoma, epratuzumab as a potential
therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for
the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer
therapy and hCD74 as a therapy for patients with multiple myeloma. We
believe that our portfolio of intellectual property, which includes
approximately 108 patents issued in the United States, and more than 250
other issued patents worldwide, protects our product candidates and
technologies. We also have a majority ownership in IBC Pharmaceuticals,
Inc., which is developing a novel Dock and Lock (DNL) methodology, and a
new method of delivering imaging and therapeutic agents selectively to
disease, especially different solid cancers (colorectal, lung, pancreas,
etc.), by proprietary, antibody-based, pretargeting methods. For additional
information on us, please visit our web site at
immunomedics. The information on our website does not,
however, form a part of this press release.
This release, in addition to historical information, may contain
forward- looking statements made pursuant to the Private Securities
Litigation Reform Act of 1995. Such statements, including statements
regarding clinical trials, out-licensing arrangements (including the timing
and amount of contingent payments), forecasts of future operating results,
and capital raising activities, involve significant risks and uncertainties
and actual results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are not
limited to, risks associated with new product development (including
clinical trials outcome and regulatory requirements/actions), our
dependence on our licensing partner for the further development of
epratuzumab for autoimmune indications, competitive risks to marketed
products and availability of required financing and other sources of funds
on acceptable terms, if at all, as well as the risks discussed in the
Company's filings with the Securities and Exchange Commission. The Company
is not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements, whether as a
result of new information, future events or otherwise.
Immunomedics, Inc.
immunomedics
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies to treat cancer and other serious diseases, today announced that
Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de
Lille, Lille, France, presented data at the 43rd Annual Meeting of the
American Society of Clinical Oncology in Chicago, IL, showing the Company's
humanized anti-CD20 monoclonal antibody (hA20) was active in patients with
non-Hodgkin's lymphoma (NHL) at a low dose of 80 mg/m2.
Current biological therapy with monoclonal antibodies for NHL includes
rituximab, which has been approved at a dose of 375 mg/m2. Immunomedics'
hA20 displays similar binding characteristics and mechanisms of action as
rituximab. Constructed using the same human donor frameworks as the
Company's anti-CD22 antibody, epratuzumab, hA20 shows an excellent safety
and tolerability profile with shorter infusion times (less than 2 hours for
the first infusion and under 1 hour for subsequent infusions) compared to
rituximab. To-date, no patients have shown an elevated immune response to
repeated injections of hA20.
Seventy-eight adult patients with CD20-positive B-cell NHL have now
been enrolled in this open-label, multi-center Phase I/II study. hA20 was
administered once weekly for four consecutive weeks at 5 dose levels: 80,
120, 200, 375, or 750 mg/m2. Treatment responses from 56 assessable
patients (38 with follicular lymphoma and 18 with non-follicular lymphoma)
with at least one post-treatment evaluation were reported at the meeting.
The overall objective response rate (partial and complete responses) was
45% (25/56), with 20% (11/56) of patients having a complete response
(CR/CRu).
In the 38 patients with follicular lymphoma, the overall response rate
was 47% (18/38), with a complete response rate of 24% (9/38). In
non-follicular lymphomas, the overall responses rate was 39% (7/18), with a
complete response rate of 11% (2/18). In a median follow-up of 8 months
post therapy, 12/25 (48%) had continuing responses, including 5 with
long-lived responses (15-24 months). At the lowest dose of 80 mg/m2, B-cell
depletion occurred after the first infusion, and 2 patients had complete
response. One in the follicular lymphoma group and the other patient had
marginal zone lymphoma. Other data are being evaluated at this low dose
with more patients accruing.
This study was extended to focus on confirming the efficacy of lower
doses at 80 and 120 mg/m2. The results confirmed that complete responses
and B-cell depletion occurred at all five doses.
"We believe the low dose allows us to develop a subcutaneous
formulation for hA20 with the goal of offering patients the benefits of
ease of use with less side effects," commented Cynthia L. Sullivan,
President and CEO of Immunomedics. "While we continue to discuss
out-licensing this product with potential partners, we plan to initiate a
study in NHL patients with the new subcutaneous formulation and to advance
the development of this humanized CD20 antibody in an autoimmune disease
using the existing intravenous formulation before the end of this calendar
year," She further remarked.
In the United States, NHL is the most common form of blood cancer,
affecting over 380,000 people. In 2007, there are approximately 63,190 new
cases and almost 18,660 deaths from this disease in the United States.
About hA20
hA20 was constructed using the same human donor frameworks and methods
employed to make the Company's anti-CD22 antibody, epratuzumab. Epratuzumab
has been studied in over 300 non-Hodgkin's lymphoma (NHL) patients and can
be infused within an hour. hA20 displays similar binding avidity,
specificity, and mechanisms of action as rituximab, but has structural
differences, and to- date shows an excellent safety and tolerability
profile, even when infused within 2 hours. At a single low dose of 80
mg/m2, hA20 depleted circulatory B-cells, and when given once weekly for 4
consecutive weeks, produced complete responses in NHL patients. Doses
between 80 and 750 mg/m2 were evaluated in this multi-center clinical
trial. To-date, no patients have shown an elevated immune response to
repeated injections of hA20.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have
developed a number of advanced proprietary technologies that allow us to
create humanized antibodies that can be used either alone in unlabeled or
"naked" form, or conjugated with radioactive isotopes, chemotherapeutics or
toxins, in each case to create highly targeted agents. Using these
technologies, we have built a pipeline of therapeutic product candidates
that utilize several different mechanisms of action. We have licensed our
lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all
autoimmune disease indications worldwide. We have retained the rights for
epratuzumab in oncology indications for which UCB has been granted a buy-in
option. UCB has development, manufacture and commercialization rights, and
is responsible for all clinical trials evaluating epratuzumab for the
treatment of patients with moderate and severe lupus. At present, there is
no cure for lupus and no new lupus drug has been approved in the U.S. in
the last 40 years. The Company is conducting clinical trials with hA20 in
patients with non-Hodgkin's lymphoma, epratuzumab as a potential
therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for
the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer
therapy and hCD74 as a therapy for patients with multiple myeloma. We
believe that our portfolio of intellectual property, which includes
approximately 108 patents issued in the United States, and more than 250
other issued patents worldwide, protects our product candidates and
technologies. We also have a majority ownership in IBC Pharmaceuticals,
Inc., which is developing a novel Dock and Lock (DNL) methodology, and a
new method of delivering imaging and therapeutic agents selectively to
disease, especially different solid cancers (colorectal, lung, pancreas,
etc.), by proprietary, antibody-based, pretargeting methods. For additional
information on us, please visit our web site at
immunomedics. The information on our website does not,
however, form a part of this press release.
This release, in addition to historical information, may contain
forward- looking statements made pursuant to the Private Securities
Litigation Reform Act of 1995. Such statements, including statements
regarding clinical trials, out-licensing arrangements (including the timing
and amount of contingent payments), forecasts of future operating results,
and capital raising activities, involve significant risks and uncertainties
and actual results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are not
limited to, risks associated with new product development (including
clinical trials outcome and regulatory requirements/actions), our
dependence on our licensing partner for the further development of
epratuzumab for autoimmune indications, competitive risks to marketed
products and availability of required financing and other sources of funds
on acceptable terms, if at all, as well as the risks discussed in the
Company's filings with the Securities and Exchange Commission. The Company
is not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements, whether as a
result of new information, future events or otherwise.
Immunomedics, Inc.
immunomedics
понедельник, 6 июня 2011 г.
Cord Blood Registry Supports Family Cord Blood Banking Act
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
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
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