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Data from Phase I/II Study of Amplimexon® in Treatment of Metastatic Malignant Melanoma
NEW YORK CITY - February 26, 2008 - AmpliMed Corporation, an InvestBio, Inc. portfolio company, recently announced one year survival results of Phase I/II trials of Amplimexon, its lead drug candidate in treating stage III or stage IV metastatic malignant melanoma (in combination with dacarbazine).
Metastatic melanoma is the most deadly form of skin cancer, affecting approximately 8,000 patients per year in the United States. Data from the Amplimexon phase I/II trials suggests that the drug had relatively infrequent side-effects, even when administered with full-dose chemotherapy. Some patients with less advanced disease in the 50-patient pool, treated with a combination of Amplimexon and dacarbazine had a survival advantage of 11.7 months, compared with approximately eight months for dacarbazine treated historical controls.
InvestBio has invested almost $10 million in AmpliMed Corporation.
"We're pleased with the preliminary data garnered from these trials by AmpliMed Corporation and we look forward to seeing the results of a larger trial to test Amplimexon®. There have been no new treatments approved for melanoma in the last decade, so AmpliMed's efforts take on an even more profound urgency," said Scott Mathis, founder and head of InvestBio and its parent company, Diversified Private Equity Corp. (DPEC Partners). InvestBio creates opportunities for accredited investors to participate in private equity investments in promising biotech companies.
Amplimexon was developed by AmpliMed co-founding scientists Drs. Evan Hersh, David Alberts, Robert Dorr and William Remers in 1994 when they initiated a program to decipher Amplimexon's novel mechanism of action. This led to the initiation in 2003 of a Phase I clinical study of the drug as a stand-alone therapy in late-stage cancer patients. Further preclinical research revealed that the combined use of Amplimexon and certain other chemotherapeutics resulted in a significant increase in efficacy compared to either drug alone. These findings are now being translated into a series of Phase I/II clinical studies of combination therapy in patients with various types of cancer.