- Initial Clinical Results Presented at the 47th Annual Meeting of American
Society of Hematology (ASH) -
ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, today reported initial response and safety results with
the Company's humanized anti-CD20 (hA20) monoclonal antibody in patients with
non-Hodgkin's lymphoma (NHL) at the 47th Annual Meeting of ASH. The results
were presented by Franck Morschhauser, MD, Centre Hospitalier Regional
Universitaire de Lille, Lille, France, lead investigator of the open-label,
multi-center, Phase I/II, dose-escalation study.
Thirty-four adult patients with documented CD20-positive B-cell NHL were
enrolled and were infused once weekly for four weeks consecutively with 120,
200, 375, or 750 mg/m(2) of hA20. Treatment responses from twenty-three
assessable patients with at least one post-treatment evaluation were reported
at the meeting. The overall objective response rate was 61% (14/23) with 26%
(6/23) of patients having a complete response (CR/CRu). Moreover, complete
responses were observed at all dose levels, including 43% (3/7) patients
receiving 120 mg/m(2) of hA20, with 28% (2/7) having a partial response.
Median infusion times for 375 mg/m(2) of hA20 were 3.3 hours for the first
infusion, 2.0 hours for subsequent infusions. At lower initial doses of 120
and 200 mg/m(2) of hA20, infusion times of 2 hours for the first and 1 hour
for subsequent infusions were reported.
"We are very encouraged by these preliminary results and are particularly
enthused by the high proportion of complete responses in patients who received
120 mg/m2 of hA20, the lowest dose used in the trial. More importantly, a
complete response rate of 43% (3/7) was observed in a small group of patients
who had 2-4 prior treatments with rituximab," remarked Cynthia L. Sullivan,
President and Chief Executive Officer. "We are in the process of formulating
the optimal dose to bring the study to the next phase," Ms. Sullivan added.
Thirty-three patients received all four infusions with one rituximab-
sensitive patient discontinuing treatment after developing allergic reactions
at first infusion. Other than mild to moderate transient infusion reactions,
predominantly with the first infusion, no significant toxicity was reported.
No immunogenicity was seen in twenty-four patients tested at least once. As
expected, peripheral blood B-cell depletion occurred after the first infusion
and persisted for samples obtained up to 12 weeks following fourth infusion,
with analysis ongoing. Pharmacokinetic results after first and fourth
infusions demonstrate a mean antibody serum half-life of 5.3 plus or minus 5.3
and 12.0 plus or minus 8.7 days, respectively.
About hA20
hA20 is a humanized monoclonal antibody that binds to the CD20 antigen on
B-cells. It contains over 90% of human amino acid sequences and the human
framework regions are identical to epratuzumab, the Company's CD22 humanized
antibody that has been studied in over 300 NHL patients. hA20 displays
similar binding avidity, specificity, and mechanisms of action, including
antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity,
and apoptosis, as rituximab. It has comparable in vitro and in vivo CD20
binding and efficacy against lymphoma as rituximab.
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. Our lead product candidate, epratuzumab, is
currently in two pivotal Phase III trials for the treatment of patients with
moderate and severe lupus (ALLEVIATE A and B). 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. We believe that our portfolio of intellectual property, which includes
approximately 90 patents issued in the United States, and more than 250 other
issued patents worldwide, protects our product candidates and technologies.
Visit our web site at http://www.immunomedics.com.
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, 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), 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.
For More Information:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis of Immunomedics, Inc.,
+1-973-605-8200, extension 123, ccheng@immunomedics.com
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