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Memgen's ISF35 Clinical Trial Featured at ASCO Annual 2009 Meeting
Published: May 26, 2009
Memgen announced today that results from a recent clinical trial of its novel active immunotherapy product, ISF35, will be presented at the annual meeting of the American Society of Clinical Oncology on June 1 in Orlando, FL.
Januario Castro, M.D., principal investigator of the phase I trial conducted at the University of California, San Diego (UCSD) will review the study's findings in an oral presentation. A single direct injection of ISF35 into a lymph node induced systemic biologic and clinical activity in patients with high-risk, progressive chronic lymphocytic leukemia (CLL).
According to Dr. Castro, one injection with no chemotherapy resulted in durable reductions in lymph nodes and spleen size in most patients. Moreover, three of fifteen patients with rapidly progressing disease did not require any further treatment for more than one year. Side effects consisted primarily of flu-like symptoms and minor injection site pain, with no long-term adverse effects observed.
These results suggest that ISF35 may be a viable option for patients who wish to avoid or are too fragile to receive chemotherapy. The direct injection of the product also positions ISF35 for use in lymphomas and solid tumor cancers.
Based on the results from this single injection study, a phase II trial evaluating multiple intranodal injections of ISF35 in CLL has begun. The Food and Drug Administration is funding the trial, which is also being conducted at UCSD under the direction of Dr. Castro.
A second Memgen study by Dr. Castro assessing the ability of ISF35 to re-sensitize refractory CLL to chemotherapy was selected by ASCO for a poster presentation. In this ongoing study, the first patient achieved a complete remission after receiving ISF35-transduced cells, followed by fludarabine, cyclophosphamide, and rituximab (FCR). The study is partially funded by the Leukemia and Lymphoma Society and is actively recruiting patients.
For more information about these clinical trials, contact Vineeta Prasad, 858-822-0337, or vprasad@ucsd.edu.
About Memgen
Memgen is a biotechnology company with its headquarters in Dallas, TX and an office in Solana Beach, CA. Memgen was founded five years ago to develop targeted active immunotherapies for the treatment of cancers. Its lead product, ISF35, has been well-tolerated while demonstrating potent anti-leukemic activity as a single agent. ISF35 causes none of the immunosuppression associated with standard cancer treatments.
For more information about Memgen, please visit www.memgenbio.com.