DALLAS, Aug. 3 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), provided an update today on its clinical development strategy for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Access has commenced a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac monotherapy in cancer patients, provide additional data to support design of combinations studies, and extend the safety database. Two ovarian cancer patients have been enrolled in the study to date, and it is anticipated 6 to 12 patients will be enrolled this year in advance of enrolling patients in trial evaluating ProLindac in combination with other chemotherapies. Access recently announced data from a recurrent ovarian cancer trial that showed that ProLindac was more active than currently available platinum drugs in that patient population, and that the drug was very well tolerated.
ProLindac is a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Platinum drugs are one of the most clinically and commercially successful class of chemotherapies and generated more than $3 billion in revenue globally in 2008. Access believes that ProLindac, as a well-tolerated and active DACH platinum, represents a important improvement in the design and tolerability of platinum chemotherapies.
Later this month, an Access management and clinical development team is meeting with Access' partner, Aosaikang Medicinal Group (ASK) and several key oncology opinion leaders to finalize plans for ProLindac development in China. In addition, Access is meeting with its Korean partner, JCOM of Seoul, South Korea to finalize development plans in that territory. Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of protocols in both China and Korea. Further, Access has reported receipt of additional milestone payments from its Far East partners in the ordinary course under their collaborative agreements.
"Our Chinese partner, ASK, has made great progress on manufacturing scale-up of ProLindac and advancing the Regulatory process with the SFDA. We are excited about finalizing protocols with ASK and the leading oncologists in China, and look forward to their continued progress," stated Jeffrey B. Davis, Access' President and CEO. "Additionally, we are meeting this month with JCOM and key opinion leaders in Korea, and hope to get the combination trials started in Korea as soon as reasonably possible."
Access intends to design all clinical studies of ProLindac in accordance with FDA standards and intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe. Access has the right to all clinical data generated in the Far East under the agreements entered into with their Far East partners, and as previously announced, believes that these trials run by its ProLindac partners will save Access between $20 and $30 million in clinical development expenses.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.
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 Aosaikang Medicinal Group ("ASK") for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting Phase 2 combination studies with ProLindac in specific tumor types at their expense based on these results.
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; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; 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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