Endo Pharma (RxKinetix) Enter PIII Trials

You may recall a little over a year ago Endo Pharmaceuticals (NASDAQ: ENDP) acquired RxKinetix whose lead product was RK-0202, a topical oral-rinse with the active ingredient formulated in its proprietary ProGelz® drug delivery platform and was in Phase II.

It sounds as if great progress is being made on RK-0202 which subsequently has become EN 3285. Endo announced that it will initiate the first of two Phase III clinical studies late in 4Q07 for EN 3285, for the prevention or delay of severe oral mucositis (OM), painful mouth sores that often occur in cancer patients undergoing radiation and chemotherapeutic treatment. Endo has agreed to the trial design with FDA under the Special Protocol Assessment (SPA) process. Under the terms of the SPA, Endo will initiate a multi-center, double-blind, placebo-controlled trial in approximately 240 OM patients undergoing chemoradiation therapy for head and neck cancer. The primary endpoint will be total radiation dose to onset of severe OM. A second Phase III study is expected to begin during the first half of 2008. The FDA will require two Phase III, double-blind, placebo-controlled trials as the basis for an NDA for this indication. As such, the company is currently projecting a 2010 NDA filing date for this product but may provide future updates depending upon the pace of patient enrollment in the clinical trials.

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RxKinetix: The Hits Keep Coming

Congratulations to Harry Ross and the entire RxKinetix team on the Endo Pharmaceuticals Holdings, Inc. (NASDAQ: ENDP) deal. The disclosed terms indicate Endo Pharma will pay a $20M up-front fee and will follow on with up to an additional $95M in clinical development and regulatory milestone payments.

Early indications are that RxKinteix, like Myogen, will remain in Colorado and continue to operate as a wholly owned subsidiary…more great news for Colorado bio.

RxKinetix's lead product is RK-0202, it is in clinical Phase II trials for the prevention of oral mucositis. Endo plans to conduct additional Phase II trials of RK- 0202 to continue to characterize the clinical profile of the product in head and neck cancer patients undergoing combination treatment of radiation and chemotherapy.

Importantly :-) CEO Harry Ross was also the first guest blogger to appear on Colorado Life Science Deal Flow, you can read his words of wisdom (here). Not only is Dr. Ross an accomplished physician, entrepreneur and investor he is also an incredibly accessible and caring individual.

With the caliber of persons such as Dr. Ross and the caliber of technology in Colorado it is only a matter of time before Colorado bio is uttered in the same breath as SF/SD and Boston.

RxKinetix – Dynamic Drug Delivery Technologies

Traveling further down the Boulder Turnpike bio corridor leads one to the steps of RxKinetix, a specialty pharmaceutical company, who is focused upon a proprietary platform of drug delivery technologies. Under the leadership of Harry Ross, MD, President and CEO, a diverse portfolio of pre-clinical and clinical opportunities has been developed.

The lead product, RK-0202 currently in Phase II clinical trials, target indication is the prophylaxis of oral mucositis in patients receiving aggressive chemotherapy to the head and neck. Up to 80% of patients receiving such treatment develop mucositis which is characterized by erosive lesions of the tongue which may ultimately permit bacteria and fungi to invade and cause systemic infections.

Additional emerging products include ProGelz™, whose proprietary drug delivery technology may substantially improve the delivery of hematopoietic growth factors to patients with cancer who are treated with myelosuppressive chemotherapy. The hematopoietic growth factor market is greater than $2 billion and ProGelz™ brings with it advantages of simplified manufacturing, reduced cost of goods and, a true sustained release mechanism.

Great strides are being made in the ProJuvant™ vaccine program, a mucosal vaccination alternative to needle injections aimed at combating infectious disease in emerging countries by eliminating blood contamination hazards and the need for highly trained medical personnel for administration. Likewise the Miconix™, a particle formulation process that produces free flowing powders with no residual solvents, business channel shows tremendous promise with broad therapeutic compound applicability.

RxKinetix has been supported by MedVenture Associates, Elan Corporation, Plc., and Aweida Venture Management