Memgen's Clinical Results on Leukemia Selected for Presentation at 2008 ASH Annual Meeting

DALLAS--(BUSINESS WIRE)--Memgen today announced that two of its clinical trials were selected for poster presentations at the annual meeting of the American Society of Hematology (ASH) on December 6-9.

Both presentations highlight clinical results for Memgen’s ISF35 active immunotherapy for the treatment of chronic lymphocytic leukemia (CLL).

In the first presentation, William Wierda, M.D., Ph.D. of M.D. Anderson Cancer Center summarizes the key results from the first ever clinical trial of ISF35.  Dr. Wierda discovered that ISF35 pretreatment sensitizes the CLL patients’ cancer cells to chemotherapy even in patients with chemotherapy refractory or resistant disease.

According to Dr. Wierda, this is a “particularly important finding, especially for patients with leukemia cells that are 17p deleted or have lost functional p53.”  These patients typically fail to respond to standard treatments.  However, ISF35 followed by fludarabine, cyclophosphamide and rituximab (FCR) produced complete and partial remissions in these patients’ p53- cancers.

Dr. Wierda also found that ISF35 has the potential to act as a single agent to stabilize CLL by activating innate immune responses against the cancer.  “There were notable and marked changes in progression of disease and stabilization was observed in many of the ISF35 treated patients,” he said.

These results suggest that patients, who may not be able to tolerate chemotherapy, may now have an alternative to standard treatment regimens that lead to long-term disease control, according to Dr. Wierda.  Side effects of ISF35 consisted mostly of mild “flu-like symptoms” and this treatment did not suppress the immune system.

The second presentation features the results from a clinical study of ISF35 conducted at the University of California, San Diego.  Januario Castro, M.D. discovered that it is possible to directly inject the ISF35 product directly into a tumor bed and generate systemic activities against the cancer.  The direct injection of the product makes it possible to use ISF35 not only in CLL, but also in a variety of lymphomas and in other cancers including malignant melanoma, lung cancer and breast cancer.

According to Dr. Castro, a single injection of ISF35 in CLL patients reduced severely swollen lymph nodes by 26% to 73% with a median reduction of 56%.  These reductions lasted from 3 to 12 months in a majority of patients.  The ISF35 injection also reduced the elevated white blood cell counts and may have slowed disease progression in these patients, most of which had rapid lymphocyte doubling times (median 3.3 months).

Memgen, with the support of the Leukemia and Lymphoma Society, has now opened a new clinical trial at the University of California, San Diego to extend the research findings of Dr. Wierda and Dr. Castro.  This trial is currently enrolling patients with refractory and/or 17p deleted CLL. This particular patient population is known to be difficult to treat, has limited therapeutic options and a poor clinical prognosis.

For more information about this clinical trial, contact Denise Darrah, 858-822-5354, or ddarrah@ucsd.edu.

About Memgen, LLC

Memgen is a biotechnology company with offices in Dallas, TX and San Diego, CA.  Memgen was founded four years ago to develop non-toxic and targeted active immunotherapies for the treatment of cancers.  Its lead product, ISF35, has demonstrated potent anti-leukemic activity as a single agent while being well tolerated.  ISF35 generates none of the immunosuppression associated with standard cancer treatments.

ISF35's results are achieved through its ability to bind to a protein found on leukemic B lymphocytes.  This activates a natural immune process that causes malignant cells to become more sensitive to subsequent chemotherapy treatments.  This targeted and active approach by ISF35 first makes the leukemias and lymphomas more "visible" to the human immune system.  Then, ISF35 activates the immune system so that it can seek out and destroy the cancerous cells.

For more information about Memgen, please visit www.memgenbio.com.