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Release issued 26th November 2002
DALLAS, TEXAS, November 26, 2002, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC) today announced the commencement of the next phase in the clinical development of Polymer Platinate AP5280. In addition, the Company released a summary of the Phase I clinical study findings.
The Phase I study findings confirmed the preclinical data. AP5280 was well tolerated at platinum doses significantly greater than the clinical doses of currently marketed platinum drugs. The dose limiting toxicity was nausea and vomiting, as opposed to the more typical severe toxicity, including renal toxicity and myelosuppression observed with cisplatin and carboplatin. No pre-hydration of patients was used in the study to minimize the side-effects of AP5280. The dosing regimen for this study was treatment every 3 weeks, which is the standard dosing schedule for carboplatin and cisplatin. Based on this dosing regimen, the safe clinical dose is estimated to be 3,300 mg/platinum per meter squared.
Additional findings of the Phase I study included:
• In preclinical models, it has been demonstrated that AP5280 forms in excess of 11 times more tumor platinum DNA adducts, the mechanism of action of platinum drugs. In the Phase I study, when it was possible to measure the tumor platinum DNA adduct level from patients dosed at various platinum doses, tumor platinum DNA adduct formation was observed at all dose levels. Tumor platinum DNA adduct levels at the higher doses were greater than those observed at clinical doses of carboplatin. • The drug elimination time was much slower than has been observed with small molecule platinum agents, providing potential for longer exposure of the drug to the tumor. • Sustained platinum release over 96 hours was observed as determined by platinum DNA adducts in plasma.
Commenting on the AP5280 program, Kerry P. Gray, President and CEO of Access, stated, "The clinical results achieved to date are consistent with the preclinical data generated on AP5280. The platinum DNA adduct formation data are very encouraging. Additionally, of significant interest is the fact that the toxicity profile of AP5280 is different to that of other platinum drugs which could offer clinical advantages when used in combination therapy with other drugs. We have commenced the next phase of the clinical development of AP5280, which is designed to assess the clinical efficacy of AP5280."
Based on the results achieved in the Phase I study and the preclinical data, which indicated that AP5280 efficacy was maximized when administered on a more frequent dosing regimen, Access has commenced enrollment in a Phase I/II study based upon a weekly dosing regimen. Utilizing the previous Phase I data to commence dosing at 1/3rd of the maximum tolerated dosing every three weeks, the initial phase will determine the weekly clinical dosing. The Phase II study will assess the clinical efficacy of AP5280 as a single therapy in ovarian cancer patients. The study is a multi-center study being conducted in Europe, and will enroll 50 patients.
Mr. Gray continued, "Our Polymer Platinate program is advancing with both AP5280 and AP5346. We anticipate that the Phase I clinical study of AP5346, a DACH platinum polymer therapeutic, will commence shortly. With the initial clinical data confirming the exciting preclinical data, we are optimistic that this technology offers the promise to improve the clinical outcome of patients being treated with platinum drugs."
Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. Access markets Aphthasol®, the only FDA-approved product for the treatment of canker sores, and is developing products for mucositis and other dermatological indications. Access is also developing unique polymer platinates for use in the treatment of cancer and has developed, in conjunction with its partner Strakan, Ltd., the marketed product Zindaclin®, which utilizes ResiDerm®, its topical zinc delivery system that provides rapid delivery and reservoir of a drug in the skin.
This press release contains certain statements that are forward-looking and that involve risks and uncertainties, including but not limited to the uncertainties associated with research and development activities, clinical trials, our ability to raise capital, the integration of acquired companies and technologies, the timing of regulatory approvals, dependence on others, collaborations, future cash flow, the timing and receipt of licensing revenues, the future success of the Company's marketed products Aphthasol® and Zindaclin® and products in development including polymer platinate, OraDiscTM and the Mucositis technology and other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, and other reports filed by us with the Securities and Exchange Commission.
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