DALLAS, Sept. 10 ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), provided an update today on the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access' clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, Ltd. ("JCOM") in Seoul, Korea, together with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer and recurrent ovarian cancer.
Access previously announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.
The recent Phase 2 recurrent ovarian study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.
"Access is extremely pleased with the clinical progress to date, and look forward to initiation of clinical trials looking at ProLindac in combination with commonly used chemotherapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East hosted Access together with key opinion leaders in oncology indications to discuss various potential protocol options, and hope to start enrolling patients in up to three combination trials by the end of the year, depending upon regulatory approvals of the trial protocols and certain other matters."
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.
Contact: Company Contact: Investor Relations Stephen B. Thompson Donald C. Weinberger/Diana Bittner (media) Vice President, Wolfe Axelrod Weinberger Assoc. LLC Chief Financial Officer (212) 370-4500 Access Pharmaceuticals, Inc. (214) 905-5100
SOURCE Access Pharmaceuticals, Inc.