Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development. Access has adopted a semi-virtual model to control costs, and advances projects by utilizing its experienced clinical and regulatory team and a small team of experienced pharmaceutical scientists. Access's scientists have unique expertise in nanopolymer chemistry platform technologies, which are utilized in several of the company's R&D programs. Through careful strategic planning designed to maximize shareholder returns, Access will either seek to advance products towards regulatory and marketing approval, co-develop products in collaboration with R&D and marketing partners or out-license products once development has advanced to a predetermined point.
While the the company's primary focus is in oncology and supportive care of cancer patients, Access has recently acquired product candidates in the dermatology field as well as additional oncology assets. Access has an approved supportive care product, one product in Phase 3 clinical development, four Phase 2 clinical candidates, and six preclinical programs in oncology, including products arising from a promising oral drug delivery technology.
In the area of supportive care, Access has received marketing allowance for MuGard in the United States from the Food and Drug Administration (FDA). MuGard is indicated for management of mucositis. Mucositis is a debilitating side effect of various cancer treatments resulting in ulceration of the oral cavity. MuGard, a proprietary nanopolymer rinse formulation, provides a protective coating to the mucosal surfaces in the mouth. A clinical study has shown MuGard to be effective in lowering the incidence and severity of mucositis. The market for mucositis treatment is estimated to be in excess of US$1 billion world-wide. In addition to receiving FDA marketing allowance in the U.S., Access has marketing partners for MuGard in three major world territories; SpePharm, for the commercialization of MuGard in the EU, Milestone Biosciences for North America, and RHEI Pharmaceuticals for certain Asian territories
ProLindac links Access' nanopolymer technolgy with the principals of prodrugs to enhance the delivery of a platinum drug to tumors. In preclinical models ProLindac protects normal tissue from the cytotoxic drug while in circulation and enhances uptake of drugs to tumors, where drug is released by virtue of a pH-sensitive linker. ProLindac completed a Phase 1 clinical study demonstrating promising signs of efficacy. ProLindac has completed a Phase 2 clinical study in patients with recurrent ovarian cancer. The drug used in ProLindac is DACH platinum, which is also the active moiety of oxaliplatin (Eloxatin; Sanofi Aventis), a drug which currently has sales of over $2.0 billion worldwide. Access has a codevelopment agreement with Nanjing Aosaikang Medicinal Group for development of ProLindac in China.
Thiarabine is a novel nucleoside product which demonstrated very promising anticancer activity in preclinical models. Following completion of two Phase 1 clinical studies, Access plans to advance thiarabine in a Phase 2 study at a leading US institute for the treatment of leukemia.
Access also has Cobalamin technologies in early-stage development. This technology is based upon the use of cobalamin coated particles derived from the company's nanopolymer chemistry technlogies. The company has extensive intellectual property surrounding the use of this technology for oral drug delivery including oral delivery of insulin and other proteins and peptides. Access receives funding from a major pharmaceutical company for the development of a Cobalamin oral drug delivery formulation of human growth hormone. In preclinical development are the Angiolix®, Prodrax®, Alchemix®, and Cobalamin programs, which have the potential to provide an exciting array of new clinical candidates.
Angiolix (HuMc3) is a humanized monoclonal antibody which binds to Lactadherin, a 46kDa extracellular matrix protein, expressed by most breast tumor cells. This binding blocks vascular endothelial cell proliferation, and induces selective programmed cell death (apoptosis) in blood vessels supporting tumors. This cuts off or reduces the supply of nutrients and oxygen to tumors and reduces tumor growth. Angiolix thus acts as an anti-angiogenesis factor like drugs such as Avastin. In preclinical studies, Angiolix displays potent anti-tumor activity in the MX-1 breast cancer tumor model.
Prodrax is a non-toxic prodrug which is targeted to be active in the low oxygen (hypoxic) regions of solid tumors. The Prodrax program comprises a series of compounds which are N-oxide prodrugs of cytotoxic anthraquinone derivatives. The N-oxide deactivates the toxic cytotoxic alkylating function while the drug is in circulation; it also serves to enhance the ability of the compound to traverse biological membranes, ensuring that the prodrug is widely distributed in the body. Prodrax compounds are non-toxic in normally oxygenated tissues as well as the oxygenated areas of solid tumors but become highly toxic in the low oxygen (hypoxic) region of tumors.
Alchemix molecules are proprietary molecules that attack tumors by two modes of action: through intercalating and alkylating properties that result in irreversible binding of the compounds to tumor DNA, thus preventing tumor replication and inducing tumor cell death. It has also been shown that Alchemix molecules are a potent inhibitors of topoisomerase II. Alchemix molecules possess potent activity across a variety of different human tumor cell lines and significantly show potent activity in cisplatin and anthracyline resistant xenograft human tumor models.
The Cobalamin oral drug delivery technology has been extended to provide nanoparticulate formulations for the enhanced targeting of drugs to sites of disease. Targeting results from the increased demand for vitamins such as cobalamin that often occurs at disease sites, such as cancer.
Access is developing Phenylbutyrate (PB) which is also in Phase 2 clinical trials. PB is a pleotropic agent which current evidence suggests acts as both an HDAC inhibitor and a differentiating agent. HDAC inhibitors have potent anticancer activity by suppressing specific enzymes found in cancer cells.
Access recently acquired two dermatological products as well as the proprietary nanopolymer drug delivery technology used in one of these products. Pexiganan is topical product for the treatment of diabetic foot ulcers. It is based on the proprietary synthetic analog of a naturally-occuring broad-spectrum antimicrobial peptide. Clinical studies have shown Pexiganan to be at least as effective as one of the standard oral antibiotics used in the treatment of diabetic foot ulcers, without the potential issues of systemic use of antibiotic. EcoNail is a nail lacquer for the treatment of onychomycosis, a common nail fungal infection.
Access Pharmaceuticals Inc.
2600 Stemmons Freeway
Dallas, TX 75207
United States - Map
Web Site: http://www.accesspharma.com
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