Clinical Trials Roundup—Week of 10/13

Merck's Vioxx Not Damaging Gastrointestinal Tract In Tests

Two new Merck studies, presented at the annual meeting of the American College of Gastroenterology, have shown that the company's Vioxx (rofecoxib) medicine for pain and arthritis has no significant differences from placebo in its effects on the mucosal integrity of the gastrointestinal tract.

For more information: Rebecca Higbee, Merck & Co., telephone: 215-652-5654.

VIMRX Announces Success of Healing Agent Trials

VIMRX Pharmaceuticals, Inc. has completed a Phase I study of VM301, a novel wound healing agent. The study reported no acute or cumulative irritation on either broken or unbroken skin and no evidence of sensitization reactions or systemic effects in its 30 volunteers.

For more infomation: Laura A. Mastrangelo, VIMRX Pharmaceuticals, Inc., telephone: 302-998-1734.

Antigenics Teams Up With Italian Company On Melanoma And Colorectal Trials

Antigenics, LLC has entered into a strategic collaboration with Sigma-Tau, Italy's second largest pharmaceutical company, to launch clinical trials in Italy using Antigenics' proprietary heat shock protein (HSP) vaccines. Antigenics' lead product, HSPPC-96, is an autologous immunotherapeutic agent designed to boost the body's immune response to cancer.

Sigma-Tau will provide logistical and financial support for Antigenics' phase II melanoma and colorectal trials to begin in the fourth quarter of 1998 in Milan.

For more information: Dr. Garo Armen, chairman and CEO, Antigenics LLC, telephone: 212-332-4774.

Pherin To Proceed With Phase I Trials Of Lead Compound

With the acceptance of its Investigational New Drug Application by the FDA, Pherin Pharmaceuticals is to proceed with Phase I clinical trials of its lead compound, PH80, for the treatment of premenstrual syndrome (PMS).

Preclinical studies of PH80 have shown that vomeropherin therapy has the potential to be a safe and novel therapeutic approach for the treatment of CNS-related disorders.

For more information: Kevin McCarthy, Pherin Pharmaceuticals, telephone: 650-324-1231.

ProScript Begins First Phase Trials Of Proteasome Inhibitor

ProScript, Inc. has initiated a Phase I clinical trial of its proteasome inhibitor PS- 341, a novel cancer therapy that targets a key protein degradation pathway in cells. The Phase I trial is being conducted at the University of Texas, M.D. Anderson Cancer Center.

PS-341 has been shown to induce apoptosis, or cell death, in cells overexpressing the BCL-2 gene, which would otherwise exhibit unregulated growth and resistance to conventional chemotherapeutics.

For more information: David Lubner, vice president, ProScript, Inc., telephone: 617-374-1470.

FDA Puts Surfaxin Therapy On The Fast Track

The U.S. FDA has designated Discovery Laboratories, Inc.'s Surfaxin therapy as a fast track product for the treatment of acute respiratory distress syndrome. Fast track status facilitates the development and expedites the review of new drugs intended for the treatment of life-threatening conditions for which there is presently no medical option.

In solution, Surfaxin is used to wash the interior of the lungs via an endotracheal tube, removing contaminates and replacing the natural surfactants, helping the lungs to reopen and improving oxygenation.

For more information: Christopher Schaber, vice president, Regulatory Affairs and Quality Assurance, Discovery Laboratories, Inc. Telephone: 215-794-3064.

Rhone-Poulenc Rorer Discontinues Klerval Development

Rhone-Poulenc Rorer has decided to discontinue the Phase II development of its GPIIb/IIIa inhibitor, Klerval. The dose necessary for achieving effective therapeutic levels of platelet inhibition has made this product economically unfeasible, the Company declared. Resources formerly allocated to the GPIIb/IIIa inhibitor will be allocated to other developments.

For more information: Beverley Miles, Rhone-Poulenc (Paris), telephone: 33-1-47-68-09-79, or Doug Arbesfeld, Rhone-Poulenc Rorer (US), telephone: 610-454-5889.