Healthcare Industry News: MuGard
News Release - June 7, 2006
Access Pharmaceuticals Provides Update on Strategic Oncology Focus; ProLindac(TM) and MuGard(TM)Jeffrey B. Davis Named Chairman of the Board; Phillip Wise Joins as Vice President, Business Development and Strategy
DALLAS, June 7 (HSMN NewsFeed) -- ACCESS PHARMACEUTICALS, INC (OTC Bulletin Board: ACCPE ) today announced new strategic and clinical initiatives in the areas of oncology and oncology supportive care. Having successfully divested non-oncology assets in 2005, the Company is now focused on the development of its core oncology product programs which include ProLindac(TM), an innovative polymer-platinum prodrug entering two Phase II clinical trials, MuGard(TM), a supportive care treatment of mucositis for patients undergoing radiation therapy and chemotherapy for cancer, and other early stage oncology compounds that utilize the Company's unique drug delivery platforms. The Company's restructuring efforts included a previously announced financing and a 1-for-5 reverse stock split.
"The past twelve months marked a very challenging period in Access' history," commented Dr. Mazanet, Access' CEO. "Despite significant challenges, as a team we were able to successfully divest non-core assets, to right-size our organization including significant outsourcing of clinical services, to focus clinical and regulatory plans for our lead cancer drugs ProLindac(TM) and MuGard(TM), and to successfully complete a financing in the first quarter of the year. The achievement of these milestones enables Access to focus on the value creation potential of our oncology products and programs."
The Company also announces the appointment of Jeffrey Davis to serve as the Company's new Chairman of the Board. J. Michael Flinn, the former Chairman, will continue to serve as a director until his term expires. Mr. Davis is currently a member of the Company's Board of Directors and is President of SCO Financial Group, a life sciences merchant bank and private equity organization that is actively engaged in the investment and development of leading small-cap biotechnology companies. Mr. Davis holds a BS in biomedical engineering from Boston University and an MBA degree from the Wharton School, University of Pennsylvania. SCO recently led a $5 million financing of the Company.
The Company also announced that Phillip Wise is joining the Company as Vice President Business Development and Strategy. Mr. Wise has been Vice President of Commercial and Business Development for Enhance Pharmaceuticals and Ardent Pharmaceuticals since 2001. Prior to that time he was with Glaxo Wellcome in various capacities. Mr. Wise holds a BS in industrial and systems engineering from Georgia Institute of Technology and an MBA degree from the University of Virginia.
"We're very excited about the potential of ACCP's oncology product programs," stated Jeffrey Davis, Chairman, "and believe the underlying value of ProLindac(TM) and MuGard(TM) is not being recognized in the market today. We are confident that new focus and strategy will give these and our other oncology products every opportunity to realize clinical and commercial success." He continued, "I thank Mike Flinn for his stewardship as Chairman through a challenging transition period, and further welcome Phillip Wise to our senior management group, and look forward to working with him on the development of our licensing programs and general business strategy."
About ProLindac(TM): The newly named ProLindac(TM), formerly known as AP5346, is a polymer-platinate product that has completed Phase I clinical testing, and is currently entering two Phase II clinical trials. The development program includes the previously announced proof of concept Phase II trial being conducted at University of California, San Diego and a company- sponsored open-label Phase II clinical trial in refractory ovarian cancer patients in Europe that will be begin dosing shortly. The Company is currently working with leading clinical investigators and research organizations to develop additional clinical trial plans, and anticipates initiating one or more additional clinical trials of ProLindac(TM) within the next twelve months. Indications of particular interest include colorectal and lung cancers in combination with current treatment regimens, with particular focus on those cancers indicated for oxaliplatin. The currently approved DACH platinum, oxaliplatin, has estimated world-wide sales of $2.6 billion.
About MuGard(TM): MuGard(TM) is an innovative mucoadhesive gel product that has been studied clinically in patients with head and neck cancer that are undergoing radiation treatment. Approximately 90% of patients undergoing radiation treatment for head and neck cancer and 20-50% of patients receiving cytotoxic chemotherapy for various cancers experience a condition known as mucositis, a very painful and debilitating ulceration and infection of the oral cavity, which can be severe enough that the patient foregoes proper treatment for the underlying cancer. In clinical trials, MuGard(TM) was shown to lessen the severity and duration of the mucositis in patients, when compared to no treatment or standard of care practices. The Company is currently finalizing the regulatory filing package for MuGard(TM), and anticipates filing the 510(k) package with the FDA in late summer. The Company is actively seeking marketing partners for this product.
About Access Pharmaceuticals, Inc.: Access 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), entering 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 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, including statements relating to the value of our products in the market, 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 to the risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2005 and other reports filed by us with the Securities and Exchange Commission.
Source: Access Pharmaceuticals
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