Access Pharmaceuticals is an emerging biopharmaceutical company specializing in products for cancer and supportive care. Access currently has one FDA-approved product, two products in Phase II clinical development, three products in preclinical development. Several of the company's products are based on Access' proprietary nanopolymer technologies which provide enhanced drug delivery options for both new and approved pharmaceutical active ingredients.

While its primary focus is in oncology, Access' drug delivery technologies also yield candidates that enable and enhance the absorption of drugs by exploiting the body's own vitamin B-12 absorption system.

Mucositis is a frequent side-effect of cancer therapy for which there is no established treatment. MuGard™ is Access' approved proprietary nanopolymer formulation for the management of mucositis. This ready–to–use rinse provides a soothing oral coating. A clinical study has shown that when MuGard is used by patients at the start of cancer therapy, the incidence and severity of mucositis are reduced. MuGard is available in Europe by prescription through Access' marketing partner, SpePharm. Access will be marketing MuGard in the United States in 2010, and marketing partners in Asia are advancing Regulatory approval of MuGard in South Korea and China.

Access is focusing its development effort on three products/technologies: ProLindac™, Thiarabine™, and Cobalamin™. The company's lead development candidate for the treatment of cancer is ProLindac™, a nanopolymer DACH platinum prodrug. ProLindac has successfully completed a European Phase II trial in patients with ovarian cancer, and Access and its Asian partners are planning to start Phase II combination studies shortly. Oxaliplatin (Eloxatin, Sanofi-Aventis) is the only DACH platinum currently approved; it has sales in excess of $2 billion.

Thiarabine™; is a Phase II nucleoside analog with considerable potential for treatment of lymphoma and leukemia. Extensive preclinical data shows that Thiarabine has good efficacy in a variety of tumor models.

Cobalamin™; is Access' proprietary nanopolymer oral drug delivery technology. Using a 'Trojan Horse' approach, the technology uses the body's natural vitamin B12 uptake mechanism in the gut to transport drugs that otherwise would have little or no oral bioavailability. The company is currently developing products for the oral delivery of insulin and human growth hormone (HGH), and is collaborating with a number of companies to develop additional formulations of various other pharmaceutically-active compounds.

MuGard
MuGard is a viscous, mucoadhesive rinse which provides a protective coating to the oral mucosa. In a comparison of patients undergoing standard care with patients using MuGard, the incidence and severity of mucositis was significantly lower for the MuGard group. MuGard has received marketing allowance in the United States under a 510(k) from the Food and Drug Administration.

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ProLindac
ProLindac is Access Pharmaceutical’s lead oncology drug, which has completed a phase 2 monotherapy study in ovarian cancer patients. It is a therapeutic, previously known as AP5346. It utilizes a safe, water-soluble nanoparticulate system to deliver DACH platinum (the active moiety of oxaliplatin) to tumors. Platinum-based drugs are among the largest classes of chemotherapeutics and oxaliplatin (Eloxatin; Sanofi-Aventis) is a DACH platinum drug that is projected to have had worldwide sales of over $2 billion in 2006.

The role of the Access’ nanoparticulate formulation of DACH platinum is to deliver more drug to the tumor while reducing delivery to normal tissue, thus increasing the drug’s effectiveness and decreasing the toxic side-effects. A major drawback of existing therapies is acute neurotoxicity. ProLindac has been shown to be much more effective than oxaliplatin in a large number of murine tumor models. In a phase 1 clinical study, at least five times more DACH platinum could be administered to patients with ProLindac than oxaliplatin. Moreover there was no indication in ProLindac of the acute neurotoxicity associated with oxaliplatin.

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Cobalamin™ -Mediated Oral Drug Delivery
Oral administration, by which pharmaceutically-active materials formulated as liquids, tablets or capsules are taken by mouth, remains by far the most prevalent method of drug delivery. It is also preferred by the vast majority of patients. However, its successful implementation requires that the active ingredient remains largely unaltered during transit through the gastrointestinal tract and that the drug possesses the requisite physico-chemical features (typically, low molecular weight, uncharged, and at least somewhat lipophilic) that allow it to pass readily across the wall of the intestine and be delivered into the bloodstream. For many active materials, particularly peptides and proteins, oral administration is currently not an option, as the level of uptake is less than one percent of the administered dose.

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CobaCyte™ - Cobalamin™ -Mediated Disease Targeting
In many diseases which involve cell proliferation, there is increased demand for certain vitamins or vitamin analogs compared with normal tissue. Access Pharmaceuticals has developed technology which takes advantage of this increase in demand. By coupling drugs to Cobalamin™ (an analog of vitamin B12 or VB12), more drug is taken up by diseased cells. This effect can be amplified by attaching Cobalamin™ and several molecules of the drug to a polymer, or encapsulating the drug in a nanoparticle coated with Cobalamin. Access owns several patents and patent applications which provide the company with a proprietary position in amplified Cobalamin™-mediated targeted delivery of drugs to diseased cells.

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Thiarabine
Several nucleoside analogs are in routine clinical use for the treatment of cancer. Interest in the class of molecule remains high; three new nucleosides have received FDA approval with the past few years (cladribine, fludarabine, and gemcitabine). Nucleosides antimetabolites are effective in treating cancer because they are similar in structure to the natural nucleosides that are the building blocks of DNA and RNA. Cancer cells are ‘fooled’ into using these unnatural nucleosides for making DNA and/or RNA, resulting in chain termination and inhibition of DNA or RNA synthesis. Cell division is inhibited and ultimately tumor cell death occurs. Small changes in the structure of nucleosides can have a profound effect on the anticancer properties of these compounds, and there has been extensive research into nucleosides to produce compounds with improved activity.

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Board of Directors

Steven H. Rouhandeh
Chairman
Chairman, SCO Financial Group LLC.

Mark Ahn, Ph.D.
Professor and Chair, Science & Technology Entrepreneurship, Victoria Management School,
University of Wellington, New Zealand

Mark J. Alvino
Managing Director, Griffin Securities, Inc.

Esteban Cvitkovic M.D.
Vice-Chairman (Europe)
Co-founder of OncoEthix

Jeffrey B. Davis
Chief Executive Officer
President, SCO Financial Group LLC.

Stephen B. Howell, M.D.
Professor of Medicine at University of California, San Diego, and Director
of Clinical Investigation and Development Therapeutics at UCSD Cancer Center

Senior Management

Jeffrey B. Davis, President and Chief Executive Officer

Esteban Cvitkovic, M.D., Vice Chairman, Senior Director, Clinical Oncology R&D

David P. Nowotnik, Ph.D., Senior Vice President Research and Development

Stephen B. Thompson, Vice President and CFO

Phillip Wise, Vice President Business Development and Strategy

Frank Jacobucci, Vice President of Sales and Marketing

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