Trial for AP5346 Polymer Platinate commences; financial results reported.(ovarian cancer)

2003 MAY 1 - (NewsRx.com & NewsRx.net) -- Access Pharmaceuticals, Inc., (AKC) announced that a phase I clinical study has commenced to evaluate AP5346, a DACH Polymer Platinate and that financial results were reported.

The phase I study is being conduced at two European sites, in France and the Netherlands. The study is designed to establish the maximum tolerated dose to be administered in future clinical studies. Where possible, tumor biopsies will be conducted to evaluate platinum tumor DNA adduct formation, which is the mechanism by which platinum is thought to inhibit tumor growth. Upon successful completion of the phase I study, a phase IIA study will be conducted in ovarian cancer patients to determine the initial efficacy of AP5346.

The recent highly successful United States launch of the first DACH- platinum compound, oxaliplatin, would suggest that a tumor-targeted analog such as AP5346 could have a significant future role in the management of cancer. Oxaliplatin was introduced into the United States market late in the third quarter 2002.

It is indicated solely for use in combination with 5-fluorouracil (5-FU) and Leucovorin for the treatment of patients whose advanced colorectal cancer has recurred or progressed following completion of first line therapy. Oxaliplatin is approved in Europe and numerous international markets with estimated annual worldwide sales already in excess of $400 million and anticipated annual market potential in excess of $1 billion.

Commenting on the AP5346 program, Kerry P. Gray, president and CEO of Access, stated, "The advancement of AP5346 into clinical development is a significant achievement, as our lead product candidate was only identified approximately 14 months prior to entering clinical development. This product candidate is supported by an extensive preclinical package which has been jointly developed with our Australian subsidiary, reflecting the scientific synergies projected when the Access Australia subsidiary was acquired.

"The rapid oncologists acceptance of oxaliplatin and the projected market penetration in only the colorectal indication, establishes the potential value of a tumor targeted DACH-platinum. Colorectal cancer is one of numerous indications Access intends to develop, assuming successful clinical development, this could be a significant product opportunity for Access."

The preclinical data which forms the basis of the advancement of AP5346 into clinical development will be presented at the 94th annual meeting of the American Association of Cancer Research to be held in Toronto, Canada, commencing on April 5, 2003. The rationale for employing a polymeric drug carrier approach is to exploit the enhanced permeability and retention effect (EPR) by which macromolecules may accumulate and be retained within a tumor. A second advantage of polymeric delivery is the potential achievement of a therapeutic index superior to that of conventional therapy (enhanced activity with altered or less severe systemic toxicity) due to rapid renal elimination of the portion of the drug not retained in the tumor.