Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
DALLAS, Aug. 20 -- Access Pharmaceuticals, Inc. provided today an update on the clinical development plan of ProLindac, its novel DACH platinum polymer prodrug, and announced plans for additional human clinical trials to be initiated in late 2007/ early 2008. The ongoing clinical trial in recurrent ovarian cancer patients, designed to optimize single agent dosing through schedule diversification and dose escalation, is currently successfully completing the enrollment of its third dose cohort.
"The excellent safety profile, especially the lack of neuro- and nephrotoxicity after multiple treatment cycles, makes it possible for us now to submit an amendment to the ongoing trial which will allow us to further and aggressively explore dosing and schedule optimization in a quicker manner," stated Dr. Esteban Cvitkovic, Vice Chairman (Europe) and recently appointed Senior Director Clinical Oncology. "The recurrent ovarian patient population is an increasingly challenging indication from a regulatory standpoint. Therefore we will continue to be careful with patient eligibility in this single agent trial. We have observed a pharmacological effect at what are still sub-toxic doses which leaves room to increase the therapeutic index in this specific indication. Moreover, this will also allow us to implement combination drug trials, the other main path to obtain further clinical evidence, in a variety of indications, of the full potential for this very promising agent."
Access Pharmaceuticals is currently planning ProLindac drug combination trials to be initiated in the fourth quarter of 2007/early 2008. As has been clinically demonstrated with Eloxatin, Sanofi's marketed DACH platinum, ProLindac's antitumor effect is expected to be synergistic when utilized in combination with other reference anti-cancer agents, such as 5-fluorourcil (5FU) or gemcitabine.
"As a result of the ProLindac results to date, we have put plans in place for ProLindac manufacturing scale-up in advance of starting these additional clinical trials and enrolling additional patients," added Stephen R. Seiler, Access' Chief Executive Officer. "We believe the enhanced safety profile of ProLindac will allow for more efficient and longer delivery of DACH platinum- based therapy with consequential patient benefit."
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 II clinical testing of patients with ovarian cancer and MuGard(TM) for the treatment of patients with mucositis. The Company also has other advanced drug delivery technologies including vitamin-mediated targeted delivery and oral drug delivery. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties including, but not limited to statements relating to the safety profile of Prolindac, our plans to commence a further clinical trial in 4Q07 or 1Q08, the pharmacological effects of Prolindac, our ability to implement combination drug trials, that the full potential for Prolindac is promising, the expectation that Prolindac will be synergistic in combination with other drugs, the enhanced safety profile of Prolindac, Prolindac's ability to allow for more efficient and longer delivery of DACH platinum-based therapy with consequential patient benefit, and the size of the potential market for Prolindac. These risks include, without limitation risks relating to our ability to continue as a going concern, anticipated product approvals and timing thereof, product opportunities, clinical trials and U.S. Food and Drug Administration ("FDA") applications, as well as our drug development strategy, our clinical development organization, expectations regarding our rate of technological developments and competition, our expectations regarding minimizing development risk and developing and introducing technology, the size of our targeted markets, the terms of future licensing arrangements, our ability to secure additional financing for our operations and our expected cash burn rate. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "could," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of such terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under "Risk Factors," that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels or activity, performance or achievements expressed or implied by such forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We are under no duty to update any of the forward-looking statements after the date of this press release to conform such statements to actual results.!--end>!--right_side-->!--start>!--end>