Fwd: [NHLlow] PP: Low Doses of humanized anti-CD20

[Guest guest]

From our good friends at NHLLOW -

Greetings,

This one we have kept a close eye on, I like low doses, metronomic

approach etc.

http://www.jci.org/cgi/content/full/105/8/1045?

view=full & pmid=10772648

(Kerbel and Folkman)

Regards,

-Ben(KIA)

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Low Doses of Humanized Anti-Cd20 Antibody Reported Active in Non-

Hodgkin's Lymphoma

- Follow-up Clinical Data Presented at the 48th Annual Meeting of

American Society of Hematology -

ORLANDO, Fla., December 11, 2006 /PRNewswire-FirstCall/ --

Immunomedics, Inc. , a biopharmaceutical company focused on

developing monoclonal antibodies to treat cancer and other serious

diseases, presented on Sunday, December 10th, follow-up clinical

data that showed the Company's humanized anti-CD20 (hA20) monoclonal

antibody was active in patients with non-Hodgkin's lymphoma (NHL) at

a dose as low as 120 mg/m(2). Results of this open-label, multi-

center Phase I/II study were reported at the 48th Annual Meeting of

American Society of Hematology (ASH) in Orlando, FL, by Franck

Morschhauser, MD, Centre Hospitalier Regional Universitaire de

Lille, Lille, France, the study's lead investigator.

In the United States, NHL is the most common form of blood cancer,

affecting over 360,000 people. Each year, there are approximately

50,000 new cases and almost 25,000 deaths from this disease in the

United States.

According to Dr. Morschhauser, " These results with hA20 compare

favorably to a published report of a similar patient population

retreated with rituximab after at least one prior course of this

antibody, where overall and complete response rates of 40% and 11%,

respectively, were observed for the usual dose of 375 mg/m(2) weekly

for four weeks (TA et al., J Clin Oncol 2000; 18:3135-43).

Throughout the doses studied with hA20, an encouragingly high

complete response rate, averaging 22%, and durable responses at each

dose level were observed in these low-grade or follicular lymphoma

patients. "

Sullivan, President and CEO of Immunomedics, commenting on

the low-dose responses seen with hA20, said, " The difference between

the two antibodies is that rituximab has been approved at a dose of

375 mg/m(2). With hA20, we can go down to 120 mg/m(2) and achieve

similar response rates and B-cell depletion. The advantages of a

lower dose include faster infusion rates and fewer side effects. "

She further commented, " Because hA20 is a humanized antibody, thus

far we have not seen any immune reaction to it. " Ms. Sullivan also

pointed out that during the study, no serious infusion related

events were reported.

A total of 57 adult patients with recurrent NHL were enrolled and

were infused once weekly for four consecutive weeks with 120, 200,

375, or 750 mg/m(2) of hA20. Fifty patients had received at least

one prior rituximab- containing regimen. Treatment responses from 48

assessable patients (32 with follicular lymphoma and 16 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 44% (21/48), with 17% (8/48) of

patients having a complete response (CR/CRu).

In the 32 patients with follicular lymphoma, the overall response

rate was 47% (15/32), with a complete response rate of 22% (7/32).

Responders were across all dose groups, even at the lowest dose of

120 mg/m(2) (approximately one-third the conventional dose of

rituximab) where 36% (5/14) were responders and 21% (3/14) had a

complete response. In non-follicular lymphomas, the overall

responses rate was 38% (6/16), including one complete response in

marginal zone lymphoma. Higher overall response rates with up to 50%

complete responses were observed at higher doses. In a median follow-

up of 11 months post therapy, 9/21(43%) had continuing responses,

including 4 with long-lived responses (15-20 months).

" We expect to complete this study soon and to advance the

development of this humanized CD20 antibody in NHL as well as

autoimmune diseases, " Ms. Sullivan said. " While we continue to

discuss out-licensing this product with potential partners, we are

simultaneously developing a subcutaneous formulation. hA20's

efficacy at low doses given the relatively small amount of protein

involved, affords us the opportunity to develop a subcutaneous

formulation, potentially providing the benefits of ease of use and

patient acceptance. "

This study was extended to focus on accruing patients at the 120

mg/m2 dose and continuing the de-escalation of doses below 120mg/m

(2). The results confirmed that hA20 was well tolerated with no

serious infusion related adverse events or immune reactions to date.

The humanized anti-CD20 antibody was infused usually within 2 hours

and depleted circulating B-cells at all doses, even after the first

week's infusion.

(http://www.immunomedics.com/news_pdf/2006_PDF/PR06052006a.pdf).

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 120 mg/m(2), hA20

depleted circulatory B-cells, and produced high complete responses

in recurrent NHL patients with prior rituximab treatments when given

once weekly over 4 concurrent weeks. Doses between 120 and 750 mg/m

(2) 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 recently 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. 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

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. 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 (including the

timing and amount of contingent payments), 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

cchengimmunomedics