Protarga reports Phase I study results with novel taxane anti-cancer drug
At the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers from Johns Hopkins presented preliminary results of a Phase I clinical study using a novel anti-cancer drug supplied by Protarga, Inc. of Conshohocken, Pennsylvania. The results showed that the first cancer patients to receive the drug Taxoprexin® DHA-paclitaxel tolerated the therapy well and experienced few side effects. The goals of the clinical study were to establish the best therapeutic dose, identify potential side effects, and measure the kinetics of the drug in the blood.
The experimental drug is a novel taxane, a class of drugs that includes the anti-cancer agents Taxol® (from Bristol-Myers Squibb) and Taxotere® (from Aventis). DHA-paclitaxel is a synthetic small molecule made by linking paclitaxel to the natural fatty acid DHA (docosahexaenoic acid). Paclitaxel is the active ingredient in Taxol®.
Drs. Antonio Wolff, Assistant Professor of Oncology, and Ross Donehower, Professor of Oncology and Medicine and Director, Division of Medical Oncology at the Johns Hopkins Oncology Center, stated that the study had enrolled seventeen patients with progressive metastatic disease, representing a range of tumor types, including colon/rectum, prostate, breast and pancreatic cancers.
The researchers reported that, at the highest dose of Taxoprexin® DHA-paclitaxel, they were able to administer 4.6 times more taxane than the maximum approved clinical dose of Taxol®. Some patients experienced a temporary reduction in their white blood cells. However, the reductions were transient and cell numbers returned to normal without treatment. None of the patients experienced hair loss or nerve problems, which are toxic side effects frequently associated with Taxol® and Taxotere®. In addition, no nausea or vomiting toxicities were seen.
Dr. Antonio Wolff, the lead author of the clinical report, said: "This is a promising new anti-cancer drug because we may be able to give patients a significantly higher dose of therapeutic taxane more safely, while extending the time of potential medical benefit." The Hopkins team emphasized that it may take several years to fully evaluate the drug's therapeutic performance and safety.
DHA-paclitaxel is designed to improve the safety and effectiveness of taxane chemotherapy by delivering more therapeutic agent to tumor cells and less to healthy tissues where side effects often occur. It is made by chemically linking paclitaxel to DHA, a fatty acid occurring naturally in the body. Studies of the drug's distribution in patients, also reported at ASCO, indicated that DHA-paclitaxel is not significantly degraded to paclitaxel in the blood, where less than one part per thousand of the drug is released as free paclitaxel. Furthermore, the half-life of the drug in the blood is two days, four times longer than paclitaxel, potentially enabling a larger therapeutic reservoir for longer periods than is currently achievable.
Previously reported preclinical studies conducted by Protarga and its collaborators comparing DHA-paclitaxel with paclitaxel had established that DHA-paclitaxel was about four-fold less toxic and its anti-tumor activity was greater in a number of tumor models.
Protarga, Inc. is a privately held pharmaceutical company located near Philadelphia, PA that develops TargaceuticalTM drugs using its patented technology http://www.protarga.com. Protarga synthesizes Targaceutical drugs by chemically linking pharmaceutical agents to natural fatty acids that are taken up by the cells targeted for treatment. Preclinical studies with this new class of drugs have demonstrated that more therapeutic agent may be delivered to diseased tissue if it is linked to an appropriate fatty acid.
This news release contains forward-looking statements that involve risks and uncertainties. The Company's actual results may differ materially from those anticipated in these statements. Factors that may cause such differences include, but are not limited to, risks and uncertainties associated with product development, the timing and outcome of clinical studies, and the timing and outcome of decisions made by the U.S. Food and Drug Administration.
Contacts: Protarga, Inc.
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