- Data demonstrates that ProLindac should provide sustained tumor exposure to platinum and provides a mechanistic rationale for the low hematoxicity observed in the clinic -
DALLAS, April 21 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced today that its collaborators at Centre Rene Huguenin in France presented new preclinical data on its lead anticancer compound, ProLindac(TM), at the American Association for Cancer Research (AACR) Annual Meeting taking place April 18-22, 2009 at the Colorado Convention Center in Denver. The poster presentation entitled "DACH platinum (dach-Pt) release kinetics, ex-vivo and in vivo plasma protein binding and evaluation of red blood cell (RBC) partitioning of ProLindac, a novel DACH-Pt-bound biopolymer" was presented on Monday, April 20.
ProLindac is Access' novel polymer-based 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 recently announced positive results from the completed phase 2 monotherapy clinical study in recurrent ovarian cancer. The study reported in the 2009 AACR poster provides in vitro and ex-vivo data on the binding of ProLindac to blood components, and suggests a mechanistic rationale for ProLindac's favorable efficacy and safety profile.
"The data shows that ProLindac's polymer carrier is highly bound to circulating plasma proteins," stated David P. Nowotnik, Ph.D., Access' Senior Vice President, Research and Development. "As a result, we would expect ProLindac to provide sustained tumor exposure to platinum. In addition, there was little red blood cell accumulation, which could account for the lower level of hematological toxicities observed for ProLindac compared to others platinum species."
"We are grateful to our European collaborators for their ongoing studies, which continue to expand our knowledge and understanding of the unique characteristics of our proprietary platinum prodrug," commented Jeffrey B. Davis, Access' President & CEO. "Following the recent announcement of positive results from the completed phase 2 clinical study in patients with recurrent ovarian cancer, and from in vitro data reported previously showing that the anticancer properties of ProLindac are enhanced when used in combination with other anticancer drugs, Access is manufacturing additional supplies of ProLindac for planned combination studies later this year."
Access currently has two development and commercialization partners for ProLindac. A licensing agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd. ("ASK") was signed in 2008 under which ASK will manufacture, develop and commercialize ProLindac for the Greater China Region which includes the People's Republic of China. In February 2009, Access announced it had signed a licensing agreement with JCOM, Ltd for South Korea for both ProLindac and MuGard, its FDA approved therapy for oral mucositis. Under these licensing agreements, Access receives milestone payments and royalties on sales. 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 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; Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate ("PB"), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate. Access recently announced the acquisition of MacroChem Corporation. This acquisition provides Access with three additional late-stage product candidates. Pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, has already completed two Phase 3 trials. EcoNail is a topically applied econazole lacquer based on Access' proprietary SEPA polymer technology, for the treatment of onychomycosis, a condition commonly known as nail fungus. Thiarabine is 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: our ability to close the financing transaction, early results from our clinical trial, Access' plans to continue and initiate clinical trials, the value of its products in the market, 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 Report on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
|SOURCE Access Pharmaceuticals, Inc.|
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