January 27, 2010 (FinancialWire) — Immunomedics, Inc. (NASDAQ: IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, presented a new method of treating advanced pancreatic cancer at the seventh annual Gastrointestinal Cancers Symposium in Orlando, Florida.

The findings of an ongoing Phase I/II study in previously untreated pancreatic cancer patients with advanced, mostly metastatic, disease involved a combination therapy consisting of a new antibody developed by the company for targeting radiation, clivatuzumab tetraxetan, and low doses of an approved anticancer drug, gemcitabine (Gemzar, Eli Lilly & Co., NYSE: LLY), given as an outpatient treatment.

At the Orlando conference, Dr. Kenneth Pennington of the Goshen Center for Cancer Care in Goshen, Indiana, reported for the research team that among the 27 patients enrolled, 22 patients were evaluable and 68% of these evaluable patients showed evidence of tumor shrinkage or stable disease, with one-third of these being assessed by computed tomography as partial responses (i.e., responses showing decreases in tumor size of more than 30% and in the absence of new lesions). Commenting on these results, Dr. Pennington stated: “Actual shrinkage of tumors by 30% or more is rarely seen when treating advanced pancreatic cancer patients, so we are of course encouraged by these initial results.”

“Furthermore, this is the first therapy that shows actual shrinkage of tumors in pancreatic cancer without patients suffering the side-effects of toxic drugs, and where the patients also have considerable quality-of-life improvements and regain more normal activities,” Dr. Pennington added. Eleven patients were able to receive more than one cycle of therapy, with one patient each having received 3 and 4 treatment cycles. Because many patients are still under therapy or observation, it is too early to assess survival results, but extended survival of up to 14.8 months from onset of therapy has been observed to date, with 8 patients achieving a survival exceeding 6 months, including 3 patients beyond one year. This outpatient treatment appears well tolerated; the only noteworthy side-effects included a drop in certain blood cells (platelets and neutrophils) for several weeks.

In addition, he said, after the first cycle, 8 of 17 patients showed improvement by positron emission tomography nuclear imaging studies (based on having more than a 25% decrease in the tumor’s metabolic uptake measured by PET), and 6 of 16 patients had >50% decreases of a biomarker (CA19-9) conventionally used to monitor pancreatic cancer disease activity.

Another cancer specialist participating in the study, Dr. Allyson J. Ocean of New York Presbyterian Hospital, Weill Medical College of Cornell University, New York City, observed that some of her patients with metastatic disease and considerable pain, “not only had CT evidence of tumor shrinkage, but reported almost complete abatement of the severe pain they had.”

The study also showed that higher doses of the radioactive antibody could increase the overall response rate (SD + PR), since patients given 12 mCi/m2 weekly for 3 weeks showed better results than those given lower doses (73% vs. 57% overall response rate). Dose escalation is continuing in this trial, which will also include the study of higher doses of gemcitabine combined with this new treatment method called radioimmunotherapy.

Cynthia L. Sullivan, president and CEO of Immunomedics, Inc., remarked: “We are developing a multi-pronged approach to the management of pancreatic cancer, involving 3 pathways: (i) early detection and diagnosis with a blood test for the PAM4 antigen; a highly sensitive and specific molecular imaging method to locate sites of pancreatic cancer in the body, both prior to treatment and following therapy; and using the radiolabeled clivatuzumab antibody in combination with gemcitabine for more specific and individualized therapy of advanced disease, with hopefully better efficacy and fewer side effects. We are pleased that promising results in two of these pathways were presented at this conference, indicating progress in these areas and the prospects of improved early diagnosis and therapy of this catastrophic disease.”

“We hope to move the current therapy program along very quickly, and then discuss our results and the next steps with the FDA, so that if these initial results continue in more patients and an actual survival benefit can be observed, we can implement the trials necessary to bring this product to pancreatic cancer patients as soon as possible,” Sullivan commented further. “This potential pancreas cancer therapeutic is an unencumbered asset that we plan to develop and commercialize by ourselves,” she added.

The clinical research team conducting this study included physicians and staff from Indiana (Goshen Center for Cancer Care), Delaware (Helen F. Graham Cancer Center at Christiana Care, Newark), North Carolina (University of North Carolina at Chapel Hill), New York (New York Presbyterian Hospital, Weill Medical College of Cornell University), Florida (University of Miami Miller School of Medicine), and New Jersey (Garden State Cancer Center, Belleville; Immunomedics, Inc., Morris Plains, NJ).

The GI Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society of Clinical Oncology, the American Society for Radiation Oncology and the Society of Surgical Oncology.

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