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
Комментариев нет:
Отправить комментарий