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WIKI ANALYSIS
Access Pharmaceuticals, Inc., a 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.
Products
Currently, Access has a number of products in its pipeline as well as one FDA approved drug (MuGard).
- MuGard, for oral mucositis
- ProLindac, for halting growth of tumors
- Cobalamin, for better absorption of medication
- Pexiganan, for treatment of diabetic foot ulcers
- Thiarabine, for treatment of tumors in leukemia and lymphoma patients
- EcoNail, for treatment of Onychomycosis, a fungal infection of the nail
- Angiolix, for treament of ovarian and breast cancer
- Prodrax, a more efficient cytotoxic drug targeting solely cancer cells
MuGard
As of June 2008, Access has one product approved by the Food and Drug Administration (FDA), namely MuGard. for the management of oral mucositis.[1] Oral mucositis is a frequent complication of cancer chemotherapy or of radiation therapy to the head and neck region. Currently available products are usually inadequate, and more effective treatment to minimize the extent and duration of mucositis is clearly needed. Historically, treatment of mucositis has been palliative and aimed at minimizing mucosal trauma. Treatments include frequent mouth cleansing and rinsing with buffered saline and fluoride solutions and administration of topical and systemic antimicrobial agents. Mucositis and infection of the mouth have remained major complications despite the usual oral care provided for patients with cancer.
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.
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.
While new cancer drugs often display minimal activity in phase 1 studies, ProLindac produced two partial responses based on MRI analysis, one partial response based on biomarker analysis (CA-125) and four cases of stable disease in an evaluable patient population of 16. A European phase 2 study to determine the efficacy and safety of ProLindac in patients with recurrent ovarian cancer has recently been completed.
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