DALLAS and NEW YORK, Nov. 3, 2010 /PRNewswire-FirstCall/ --ACCESS PHARMACEUTICALS, INC.(OTC Bulletin Board: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has commenced a Phase 2 combination trial for its second generation DACH-platinum cancer drug, ProLindac, in platinum-sensitive ovarian-cancer patients. This trial is an open-label, Phase 2 study of ProLindac given intravenously with paclitaxel. The combination trial will be conducted in up to eight European participating centers.
“We are very pleased to be able to begin this trial, which will be the first of several ProLindac-based combination studies in a variety of indications,” said Prof. Esteban Cvitkovic, Vice Chairman Europe and Senior Director Clinical Oncology R&D, Access Pharmaceuticals, Inc. He continued, “The ambitious two-step design of the study will allow us to rapidly benchmark ProLindac/paclitaxel in a clinical setting where there is a clear need to establish an improved standard for long-term tumor responses. When treated using the current first-line combination of carboplatin/paclitaxel, more than half of patients with advanced ovarian cancer will relapse. There are very few second-line options. Approved agents for second-line and later therapy are currently focused primarily on the palliation of more resistant tumors. This lack of valid second-line options presents an opportunity to prove the role of ProLindac-based combinations in ovarian cancer.”
“After optimizing ProLindac’s scaled-up manufacturing process, we are pleased to be moving forward with its clinical development,” said Jeff Davis, President and CEO, Access Pharmaceuticals, Inc. He continued, “We think there is a significant clinical need and commercial opportunity for safer, more effective platinum drugs.”
Access previously announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac 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, including sustained significant reductions in Ca-125, the established specific serum marker for ovarian cancer, observed in several patients. No patient in any dose group exhibited signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin. ProLindac was very well tolerated, with only minor sporadic hematologic toxicity.
Access is evaluating various indications where DACH Platinum-based combinations have proven already active, such as hepatocarcinoma, biliary tree cancer and pancreatic cancer before deciding on an expanded Phase 2 program.
About ProLindac:
ProLindac is a novel DACH platinum prodrug that has completed a phase 2 monotherapy study in ovarian cancer patients. It is a polymer therapeutic that utilizes a safe, water-soluble nanoparticulate system to deliver DACH platinum to tumors, while reducing delivery to normal tissue, resulting in increases drug effectiveness and a significant decrease in toxic side-effects seen in the currently marketed DACH platinum, Eloxatin (Sanofi-Aventis), which has sales in excess of $2 billion.
For more information, please visit http://www.accesspharma.com/product-programs/prolindac/.
About Access:
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard (www.MuGard.com), for the management of patients with mucositis, ProLindac, currently in Phase II clinical testing of patients with ovarian cancer, and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.
The company also has additional advanced drug-delivery technologies, including CobaCyte-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. 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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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 | |
Christine Berni | Donald C. Weinberger/Diana Bittner (media) | |
Director of Investor Relations | Wolfe Axelrod Weinberger Assoc. LLC | |
Access Pharmaceuticals, Inc. | (212) 370-4500 | |
(212) 786-6208 | ||
SOURCE ACCESS PHARMACEUTICALS, INC.
