Access Pharmaceuticals Announces Presentation on ProLindac Phase 2 Study at AACR-NCI-EORTC 'Molecular Targets and Cancer Therapeutics' ConferenceProLindac Shows Clinically Meaningful Stabilizations and Consistent Early Signs of Anti-Tumor Activity.
DALLAS, October 24, 2007 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. announced today that a poster providing early evidence of efficacy from the ProLindac(TM) Phase 2 Clinical Study in Recurrent Ovarian Cancer was presented yesterday at the joint symposium of the American Association for Cancer Research (AACR), National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) entitled "International Conference Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications."
The presentation reported initial data from an ongoing ovarian cancer study utilizing ProLindac at two and three week intervals. Significantly, there was a reduction of the Ca125 biomarker in five of the six patients in the cohort receiving the higher dose of ProLindac on a once every three week dosing schedule. The Ca125 biomarker has been demonstrated to be a reliable indicator of the clinical progression of ovarian cancer, and it has been shown that a reduction in this biomarker provides an early sign that a treatment regimen is effective in combating ovarian cancer. Dose escalation in the trial is continuing. At the reported doses, toxic effects observed were generally mild and ProLindac displayed none of the acute neurotoxicity associated with other approved DACH platinum compounds.
"This early result provides us with a very positive indication that ProLindac is capable of effecting clinically meaningful stabilization of patients with ovarian cancer," stated Dr. Esteban Cvitkovic, Access' Vice-Chairman (Europe) and Senior Director, Oncology Clinical R&D. "Moreover, there was no indication of nephrotoxicity in any patient, and the only indication of neurotoxicity was a delayed, slight increase in baseline in two patients with such baseline conditions of neurotoxicity. These data allow us to continue dose escalation in order to establish a higher therapeutic index. It will also allow us to expand the study into a ProLindac combination drug trial to fully explore the potential of this very promising agent."
"We are very pleased by the activity and safety of ProLindac in the early cohorts of the ovarian cancer trial," added Stephen R. Seiler Access' President and CEO, "Even as we continue dose escalation in the current trial, existing results have given us sufficient confidence to move forward with the execution of additional development plans for ProLindac and we have already commenced manufacturing drug supply for several further clinical trials, including combination trials, which we plan to commence beginning next year."
The ProLindac Phase 2 clinical study in recurrent ovarian cancer is continuing at eleven leading oncology centers in France, and it is anticipated that further results will be reported on the study at leading oncology conferences in 2008. Access anticipates the initiation of additional Phase 2 studies in other indications during the first quarter of 2008.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery. Access has announced the execution of a definitive merger agreement to acquire Somanta. The acquisition of Somanta has not yet closed and the closing is subject to numerous closing conditions. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com .
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: early results from our clinical trial, Access' plans to continue and initiate clinical trials as well as combination trials, planned dose escalation, the absence of nephrotoxicity, the ability to establish a higher therapeutic index for ProLindac, the value of its products in the market, its ability to achieve clinical and commercial success, its ability to successfully develop marketed products and the ability to obtain or meet the closing conditions in the merger agreement with Somanta Pharmaceuticals, Inc. and applicable regulatory and tax requirements, and to otherwise complete the merger in a timely manner, yet there can be no assurances that the closing conditions will be met or waived or that the transaction will close. These statements are subject to numerous risks, including but not limited Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' and Somanta's Annual Reports on Form 10-KSB and other reports filed by Access and Somanta with the Securities and Exchange Commission.
CONTACT: Stephen B. Thompson, Vice President, Chief Financial Officer ofAccess Pharmaceuticals, Inc., +1-214-905-5100; or investor relations,Donald C. Weinberger, or media, Alisa Steinberg, both of Wolfe AxelrodWeinberger Assoc. LLC, +1-212-370-4500, or Andrew Hellman of CEOcast, Inc.,+1-212-732-4300, all for Access Pharmaceuticals
Web site: http://www.accesspharma.com/
Ticker Symbol: (NASDAQ-OTCBB:ACCP)
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Posted: October 2007