News
ASCO Presentation Highlights Memgen's ISF35 Anti-Cancer Activity in Chronic Lymphocytic Leukemia
Published: June 04, 2009
DALLAS - Results from the latest clinical trials completed with Memgen’s cancer immune therapy, ISF35, were presented at the American Society of Clinical Oncology annual meeting in Orlando June 1.
Januario Castro, M.D., delivered an oral presentation announcing that a clinical trial evaluating the safety and efficacy of a single injection of ISF35 directly into a lymph node resulted in significant anti-leukemic activity in patients with chronic lymphocytic leukemia (CLL).
According to Dr. Castro, direct injection of ISF35 was shown to consistently reduce leukemia cell counts, lymph nodes, and spleen in patients with CLL. Correlative studies, including analyses of pro-apoptotic factors and T cell counts, corroborated the anti-cancer activity exhibited in the 15-patient study.
The trial focused on high-risk, progressive CLL, characterized by a high degree of circulating CLL cells, enlarged lymph nodes, and median lymphocyte doubling time of 3.7 months. Following a single injection of ISF35, at least a 50% decrease in circulating lymphocytes was observed in nearly half of participating patients. Almost two-thirds of patients experienced at least a 50% decrease in swollen lymph nodes during the trial, and the spleen returned to normal size in 40% of patients, according to the presentation.
The study builds upon findings from prior clinical trials at UCSD and M. D. Anderson Cancer Center and on preclinical studies that demonstrated the activity of single agent ISF35 as a potent treatment for B cell malignancies.
In addition to direct injection, ISF35 can be administered by using CLL cells modified outside the body and re-introduced to the patients by intravenous infusion. Past and ongoing clinical trials have established these two modes of administration and demonstrate the potential versatility of ISF35, which may be applicable to a number of hematological and solid tumor cancers, including lymphoma, malignant melanoma, and cancers of the breast, pancreas, prostate, and lung.
Memgen’s clinical development plan includes an ongoing Phase I trial of ISF35-transduced cells combined with chemotherapy in refractory and/or 17p deleted CLL that is co-sponsored by the Leukemia & Lymphoma Society. Also, the FDA Office of Orphan Drug Development is funding a Phase II multiple direct injection trial of ISF35 in CLL. A Phase II trial using multiple direct injections of ISF35 for the treatment of patients with non-Hodgkin lymphoma is planned for later this year.
Dr. Castro is overseeing both studies at the University of California, San Diego (UCSD). Thomas Kipps, M.D., Ph.D., one of the most well-known authorities on CLL and the primary inventor of the ISF35 technology, is also involved with the development of ISF35 at UCSD.
For more information about clinical trials at UCSD, 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.