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Access Pharmaceuticals (ACCP: OTCBB) is an emerging specialty pharma company developing and commercializing propriety products for the treatment and supportive care of cancer patients. MuGard, its FDA approved treatment for oral mucositis, is commercially launched in Europe, and will launch in the US and Asian in 1Q 2010. ProLindac, which is in pivotal clinical trials, is a new and improved version of Sanofi-Aventis’ Eloxatin, a DACH Platinum chemotherapeutic. Thiarabine is in human trials for the treatment of leukemias and lymphomas. Lastly, ACCP has collaborations in the areas of oral insulin and oral human growth hormone, using it’s proprietary Cobalamin based oral drug delivery platform.
Access Pharmaceuticals’ Cobalamin oral platform could offer new way to administer insulin
In recent months, news flow and analyst comments in US listed Access Pharmaceuticals (OTC:ACCP) has been primarily focused on the company’s oral mucositis product, MuGard, which is in the midst of commercialization in Europe. However, this morning observers and investors alike were reminded that this junior pharmaceutical company has an interesting pipeline of other products in its arsenal, including Cobalamin, a platform based on vitamin B12.
What makes Cobalamin interesting is its multi-application potential as a facilitator of oral absorption of pharmaceuticals.
This morning, Access Pharma reported that two independent animal studies confirmed earlier findings that Cobalamin offers “significant bioavailability of orally delivered insulin”. At present, there is no product in the market which offers oral administration of insulin.
In layman’s terms, bioavailability refers to how well a drug (in this case insulin) is absorbed into the body. With any application, the key to success is not only to ensure a high percentage of the drug is absorbed, but additionally that it can be predicted ahead of time to ensure correct dosage. Hence Cobalamin as an oral drug delivery technology could supersede many products that still require injections or intravenous therapy (in the case of diabetes the most common practices is a disposable insulin ‘pen’).
Access has previously reported that its Cobalamin-coated insulin containing nanoparticle formulations, delivered orally, provided a pharmacological response (lowering of blood glucose level) equivalent to “greater than 80% of that achieved by insulin delivered subcutaneously” (beneath the skin). Currently Insulin is most commonly given as an injection under the skin, usually into the thigh, buttocks, abdomen or upper arm.
“We remain excited about the potential of our Cobalamin oral drug delivery technology, and the positive data being generated,” stated Jeff Davis, CEO of Access Pharmaceuticals this morning. Phillip Wise, Vice President of Business Development Strategy added that the company was in discussions with several companies about “options” to apply its Cobalamin platform to other drugs.
Access has previously reported equally encouraging non-human trials for delivering human growth hormones (HGH).
“The Company believes the substantial oral bioavailability found underscores the formulation’s potential for clinical development and ultimate commercialization,” the company reiterated. “Additionally, Access believes that its Cobalamin Oral Drug Delivery Technology has broad application to proteins, small molecule drugs, hormones, and potentially sRNAi therapeutics.”
Access Pharmaceuticals recently began a pre-licensing program to confirm the utility of Cobalamin for targeted delivery of siRNA therapies (SiRNA stands for small interfering RNA, but is sometimes referred to as short interfering RNA or silencing RNA).
Access said industry researchers have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill. Cobalamin's vitamin B12 uptake mechanism offers the potential for targeted delivery of siRNA because most human cells have a requirement for vitamin B12.
