Stem Cell Therapeutics

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Stem Cell Therapeutics

Postby bromley » Wed Sep 13, 2006 8:09 am

I think EPO is on the list.

Ian


Stem Cell Therapeutics Options Schizophrenia and Multiple Sclerosis Clinical Programs

Stem Cell Therapeutics Corp. (SCT), a Canadian biotechnology company engaged in treating central nervous system (CNS) disorders by stimulating endogenous neural stem cells, is pleased to announce that it has entered into an Option to Acquire agreement for up to two additional clinical stage programs, one in schizophrenia and the other in multiple sclerosis. The agreement between SCT and two researchers from the Max Planck Institute of Experimental Medicine in Germany provides SCT with the right, but not the obligation, to acquire one or both of the clinical stage programs under option.

The two clinical programs described in the agreement are each based on therapeutic approaches to treating CNS disorders with erythropoietin (EPO) and are protected by pending patent applications. SCT will pay no fees in association with the Option to Acquire unless exercised. If exercised SCT will pay certain upfront, milestone and clinical trial support costs in respect of any programs acquired. Conditions of exercising the Option to Acquire by SCT include satisfactory completion of due diligence, approval by SCT's board of directors, and the determination that sufficient resources are available so that SCT can advance the optioned program(s) without impeding the advancement of our lead NTx(TM)-265 stroke program. The term of the agreement is for a period of six months, and may be extended at no cost for an additional six months upon mutual agreement.

SCT's lead program, NTx(TM)-265, employs a regimented treatment of human chorionic gonadotropin (hCG) followed by EPO and is currently enrolling in a Phase IIa clinical study in recent stroke patients. The two programs optioned under the agreement also employ EPO as a therapeutic intervention for severe, poorly treated neurological conditions, in this case schizophrenia and multiple sclerosis.

If the Option to Acquire is exercised by SCT, the company will have three Phase II clinical programs in progress that employ EPO alone or in combination with other agents for the treatment of serious CNS diseases.

The multiple sclerosis program captured in the agreement has already completed a 24 week open label Phase IIa clinical study seeking improvement in walking distance and Kurtzke Expanded Disability Status Scale (EDSS) efficacy endpoints in chronic progressive multiple sclerosis patients treated with high vs. low doses of EPO. The next clinical development step for the multiple sclerosis program is likely a Phase IIb double blind placebo controlled efficacy study.

SCT's therapeutic approach is based on neuroregenerative and neuroprotective properties demonstrated by hCG and EPO in laboratory research and animal models of CNS disease. The EPO therapies employed in the schizophrenia and multiple sclerosis programs are based on similar therapeutic mechanisms to SCT's and thus represent an attractive complement to SCT's NTx(TM)-265 clinical program for stroke, providing numerous synergies and allowing the leveraging of the company's core competencies and intellectual property. Additionally, the described clinical use of EPO in these two studies further enhances the safety data profile of EPO administration for chronic neurological diseases.

"We are excited by the potential that these two clinical stage programs could add to SCT, if these programs satisfactorily complete our due diligence process and we exercise our Option," said Dr. Joseph Tucker, President and CEO of SCT. "Complementing our recently announced license with StemCells Inc., these programs could contribute important components to SCT's continued growth. With the potential to combine our NTx(TM)-265 stroke program with one or both of the additional Phase II clinical programs that also employ EPO, SCT aims to be a leading company with both a significant intellectual property position and a growing base of clinical evidence supporting the repurposing of EPO and other molecules for use in neurological disease."

Source: CNW Group
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