Washington-based biopharmaceutical company SCOLR has said that it has completed a biotrial providing Proof of Concept for its Self Correcting Oral Linear Release drug delivery systems in human subjects.
The company said that interim results showed a positive correlation with the in-vitro experiments conducted on the company's patented CDT drug delivery platform. The new technology offers a valuable alternative to existing modified dosage forms (including reservoir and multi-particulate systems which are complicated and expensive), added SCOLR.
The results of the trial, currently under final analysis at Temple University by Dr Reza Fassihi, are expected to be published next month. Dr Fassihi, professor of Biopharmaceutics and Industrial Pharmacy at the Temple University School of Pharmacy and inventor of the three patented Controlled Delivery Technology platforms, is working with SCOLR on development of the CDT technology. He will present the final results at the American Association of Pharmaceutical Scientists (AAPS) in mid-November in Toronto, Canada.
The Controlled Delivery Technology biotrial was conducted in collaboration with NorthWest Kinetics, a Tacoma, Washington-based clinical research organisation specialising in Phase I and Phase II clinical trials. The double-blind trial involved 18 fed and 18 fasted patients receiving single daily dosings of the test compound, a highly soluble and permeable BCS Class 1 drug.
David Howard, CEO and president of SCOLR, said: "Our first successful human biotrial has clearly demonstrated that the Self Correcting Oral Linear Release delivery platforms…are viable alternatives to older drug delivery systems."
He added: "These results support our belief that CDT technology offers a real alternative to the pharmaceutical industry which is seeking new, powerful oral delivery systems offering lower cost and faster-to-market capabilities."
SCOLR's technology can be used to introduce distinctive and novel OTC products, prescription drugs and dietary supplements.
SCOLR, formerly Nutraceutix, has begun discussions with drug delivery and pharmaceutical companies involved in the domestic $20 billion oral drug delivery market, as potential licensing partners of the CDT technology.
"We expect to secure our first pharmaceutical product project during the first half of 2003," Howard said.