NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Immunomedics, Inc. (Nasdaq:
IMMU) announced today that two potential products showed promising activity in
the treatment of aggressive non-Hodgkin's lymphoma (NHL), and that a new
product candidate is showing high activity in a human multiple myeloma animal
model.
A pilot clinical study of epratuzumab, Immunomedics' humanized anti-CD22
monoclonal antibody, in combination with rituximab and CHOP chemotherapy
(ER-CHOP), was studied in previously untreated patients with diffuse large
B-cell lymphoma (DLBCL) to assess safety and activity (Poster 6580).
Conducted by the Eastern Oncology Cooperative Group (ECOG) of the National
Cancer Institute at the Mayo Clinic in Rochester, MN, and the University of
Wisconsin in Madison, WI, fifteen patients with untreated DLBCL were evaluated
after administration of 6-8 cycles of ER-CHOP, given every 21 days. Twelve
patients received 6 cycles of therapy, 2 received 8, and one patient went off
study after 4 cycles, due to toxicity. The major toxicity was grade-4
neutropenia (decrease in white blood cells), which occurred in 93% of the
patients and which appears to be higher than in studies using rituximab with
CHOP chemotherapy, but the authors cautioned that this may be due to more
intensive monitoring of blood cell counts compared to prior studies. Despite
the high incidence of grade-4 neutropenia, there were only 3 patients who
developed infection or fever, and the incidence of neutropenia could be
managed by the use of growth factors. The most encouraging aspect of the
study was an objective response rate of 87%, with 67% of the patients having a
complete response, suggesting to the authors that further studies of this
regimen are needed.
Poster 6579 reported results on a European multicenter, Phase-II, trial of
epratuzumab combined with rituximab administered weekly for 4 weeks in
relapsed/refractory indolent (45 patients) and aggressive (20) NHL patients.
Presented by Dr. Sandra Strauss of St. Bartholomew's Hospital, London, United
Kingdom, it was found that the combination of these two antibodies is feasible
and well tolerated. Promising objective response rates (complete and partial
responses) were achieved in both follicular lymphoma (57%) and diffuse large
B-cell lymphoma (46%), including high rates of complete response (23% and 31%,
respectively). The investigators reported that the response rates depended
strongly on the baseline international prognostic index (IPI) status of the
patients, where patients having the best disease prognosis showed an objective
response rate of 73% and a complete response rate of 36%, whereas those with
the worst prognosis had a 25% objective response rate with no complete
responses.
"This may explain differences in response rates and durations of response
observed in previous studies involving the combination of epratuzumab with
rituximab," explained Dr. Ivan D. Horak, a coauthor of the study and Executive
Vice President of Research and Development, and Chief Scientific Officer, at
Immunomedics. "This promising activity warrants further study in a
prospective, well-controlled, randomized clinical trial, where rituximab alone
vs. the combination can be compared in an identical population of NHL
patients," Dr. Horak added.
The radio labeled form of epratuzumab (90Y-DOTA-epratuzumab) is being
studied in a Phase I/II dose-escalation trial in Europe, involving
fractionated doses of 90Y-DOTA-epratuzumab given over 2 or 3 weeks, and
presented as an interim report in Poster 2545 with Professor J. F. Chatal of
Nantes, France, as senior author. In all of the current 28 patients with
indolent and aggressive NHL of diverse disease status, an objective response
rate of 50% (38% complete responses) was observed, whereby in the group
receiving the higher dose fractionated schedule, a 53% objective response rate
(47% compete responses) was found. In the follicular NHL group, a 69%
objective response rate, with 54% complete responses, also was reported. The
complete responses, according to the authors, appeared to be durable, still
continuing up to more than 23 months. No significant toxicity other than
hematological were observed, and 4 of the patients could be retreated without
additional toxicity. The authors also observed initial promising responses in
patients refractory to other therapies, especially in patients with mantle
cell lymphoma (29% complete response rate). Although the maximum tolerated
dose of the fractionated therapy has not been reached yet, Professor Chatal
and his collaborators concluded that this treatment appears to be well
tolerated and efficacious, with manageable hematological toxicity.
Poster 6535, with Dr. Rhona Stein of the Garden State Cancer Center,
Belleville, NJ, as the senior author, showed that Immunomedics' drug
conjugate, IMMU-110, which comprises doxorubicin conjugated to a humanized
anti-CD74 monoclonal antibody, had significant antitumor effects in a multiple
myeloma animal model. The mice treated with this drug conjugate showed more
than a 500% life-extension as compared to control, untreated mice. The
studies also revealed that the anti-CD74 antibody by itself has antitumor
effects in this model.
"Although still involving preclinical models of lymphoma and myeloma, our
studies with IMMU-110 encourage us to consider this agent as a potential new
product for the treatment of these hematological diseases," commented Dr.
Horak. "Our humanized CD74 monoclonal antibody is very attractive due to its
rapid internalization into tumor cells expressing CD74, and the fact that we
are observing antitumor activity with the naked antibody by itself," he
explained further.
Immunomedics is a biopharmaceutical company focused on the development,
manufacture and commercialization of diagnostic imaging and therapeutic
products for the detection and treatment of cancer and other serious diseases.
Integral to these products are highly specific monoclonal antibodies and
antibody fragments designed to deliver radioisotopes and chemotherapeutic
agents to tumors and other sites of disease. Immunomedics has nine
therapeutic product candidates in clinical development and has two marketed
diagnostic imaging products. The most advanced therapeutic product candidates
are LymphoCide(R) (epratuzumab), for which certain Phase II clinical trials
for the treatment of non-Hodgkin's lymphoma have already been completed, and
CEA-Cide(R) (labetuzumab), which is in Phase I/II clinical trials for the
treatment of certain solid tumors.
This release, in addition to historical information, contains
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials, 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 financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the year June 30, 2003. 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.
Company Contact: Trish Merwin, Finance & Investor Relations Coordinator,
(973) 605-8200, extension 263. Visit the Company's web site at
http://www.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:
Trish Merwin, Finance & Investor Relations
Coordinator of Immunomedics, Inc., +1-973-605-8200, ext. 263
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