Access Pharmaceuticals Announces Completion of ProLindac Monotherapy Trial and Initiation of Combination Study

Update on Worldwide Development on ProLindac

Jan 07, 2010, 08:30 ET from Access Pharmaceuticals, Inc.

DALLAS, Jan. 7 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today announced that it has completed enrollment and evaluation of the last additional cohort of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens. The additional cohort of 8 patients received the ProLindac batch made by an improved scalable process, which will be used on a larger scale for future clinical and commercial supplies. None of the 8 patients experienced any acute significant adverse events, while treatment had the same beneficial pharmacodynamic effect seen in the first 26 patients treated with the former ProLindac production batch; clinically relevant sustained biomarker decrease (responses by Rustin's criteria) and disease stabilization were seen in several patients. The overall results of our Phase I/II exploratory single agent ProLindac study have helped define multiple safe dosing regimens, while the level of patient cohort accrued in the study antitumor activity was as expected in this very heavily pretreated patient cohort.

Based on these results, Access is initiating a study of ProLindac combined with Paclitaxel in second line treatment of platinum pretreated advanced ovarian cancer patients. This study is the first to look at the safety and efficacy of ProLindac in combination with other oncology agents. "The efficacy of Diamino Cyclohexane Platinum, the active principle in ProLindac, is evidenced mainly through their synergic association with multiple anticancer agents. The choice of Paclitaxel and ovarian cancer as the potential first NDA strategic choice to be explored is based on the excellent results of the Paclitaxel/Oxaliplatin combination in the same clinical setting. This multi-center study of up to 25 evaluable patients will be conducted in Europe. The very ambitious primary efficacy endpoint goal is to achieve a minimum of 63% response rate in the total of 25 evaluable patients the study is planning to accrue on a two step design. We are very reassured and pleased with these results and the quality of the latest scalable process product, which is driving us towards an ambitious NDA strategy with an exploratory trial based upon the well known synergistic power of DACH platinums with a variety of anticancer agents," stated Prof. Esteban Cvitkovic, Vice Chairman of Access and a clinical oncologist overseeing the combination study in Europe. "We are confident that ProLindac in combination with Paclitaxel will be well tolerated in this patient population and anticipate significant activity based on our current experience with ProLindac in heavily pretreated patients."

"This first combination study is a major milestone for ProLindac and Access Pharmaceuticals. We believe the data generated by the combination study will demonstrate that this combination can be an effective treatment option for patients with hard to treat late stage ovarian cancer," stated Jeffrey B. Davis, President & CEO of Access. "Our efforts, combined with the efforts of our Asian partners, are targeted at demonstrating the safety and efficacy of ProLindac in multiple combination treatment protocols for a range of cancer types. We believe ProLindac is new DACH platinum chemotherapy in continued clinical development at this stage."

Access' Asian partners continue to prepare regulatory and other filings in South Korea and China to commence additional combination clinical studies with ProLindac. These studies are expected to provide clinical data for additional indications for ProLindac beyond late stage ovarian cancer. Additional indications under consideration include hepatocellular carcinoma, pancreatic, endometrial and others.

About ProLindac(TM):

ProLindac is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. Access believes that ProLindac's unique molecular design potentially could eliminate some of the toxic side effects seen in the currently marketed DACH platinum, Eloxatin, which has sales in excess of $2 billion. Access has previously announced that it has licensed ProLindac to Jiangsu Aosaikang Pharmaceutical Co., Ltd. ("ASK") for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting combination studies with ProLindac in specific tumor types at their expense based on these results.

About Access:

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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our website at 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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access' plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. 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' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

SOURCE Access Pharmaceuticals, Inc.



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