CALGARY, Aug. 24 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. ("SCT") and Medicon A/S ("Medicon") of Birkerod, Denmark announced today they have signed a Letter of Intent ("LOI") for SCT to retain Medicon to conduct SCT's first Phase I clinical trial in the NTx(TM)-265 therapeutic program for the treatment of stroke.
"We are pleased to announce entering into this LOI with Medicon as it marks a key step towards further developing our NTx(TM)-265 stroke clinical program" stated Dr. Joseph Tucker, President and CEO of SCT. "We look forward to working with a company of Medicon's stature as it is recognized as one of Europe's largest and most modern facilities that conduct clinical trials quickly and efficiently".
SCT and Medicon recently received a positive preliminary response from both the Danish Regulatory officials and the regional Ethics Committee to the Phase I clinical trial synopsis. Following a review of the clinical trial synopsis, both agencies responded by providing no objections to proceed with a final protocol submission of SCT's planned Phase I Clinical study for NTx(TM)-265.
"The successful achievement of receiving this positive response was an important first step towards further developing our NTx(TM)-265 stroke clinical program" said Dr. Joseph Tucker, President and CEO of SCT. "The positive response from the Danish Regulatory Authorities and local ethics approval encourages us to proceed with our clinical trial program in Europe and also validates our ongoing development strategy".
SCT had previously engaged Medicon to prepare both a synopsis and a feasibility study of SCT's planned Phase I clinical study. The synopsis was submitted to the Danish Regulatory Agency and to the Ethics Committee in July 2005.
"The next step for SCT is to finalize the writing of the entire clinical trial protocol and package and subsequently submit it to Danish regulatory authorities for approval to proceed into the clinic", stated Dr. Alan Moore, Chief Clinical & Regulatory Officer of SCT. "We anticipate that with Medicon's expertise and experience in developing clinical trial programs that the completed package will be submitted to the Danish Regulatory Agency and the Ethics Committee by mid October, with formal approval to initiate our first Phase I clinical trial expected to occur approximately 6 weeks following the submission".
About Medicon A/S: Medicon A/S is a 20 year old Drug Development Organisation with a documented success in clinical research with scientific impact and with a track record of high quality trials. With its team of +60 FTE specialists it offers fast track solutions within all services for phases I-IV studies, from synopsis to NDA, data management & statistics, QM, audit and training. Medicon Clinical Pharmacology is one of Europe's largest and most modern facilities with 60 beds offering phase I trials in healthy volunteers, phase IIa trials in patients recruited from regional hospitals and definitive QT-trials.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a biotechnology company focused on the development of its technology platform and intellectual property to selectively induce a patient's own stem cells to proliferate in the brain. SCT's core technology, which includes its lead therapeutic product NTx(TM)-265, has been demonstrated to increase the number of innate adult stem cells that grow in place when this therapeutic approach is applied to test animals. SCT plans to develop this fundamental technology further for specific disease treatments such as stroke, and potentially Huntington's disease, Alzheimer's disease and other neurodegenerative conditions.
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These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available. Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
Stem Cell Therapeutics Corp.
CONTACT: on Stem Cell Therapeutics Corp., visit www.stemcellthera.com orcontact: Dr. Joseph Tucker, Chief Executive Officer, Stem Cell TherapeuticsCorp., Phone: (403) 245-5495, email@example.com; For furtherinformation on Medicon, visit www.medicon.dk or contact: Dr. Poul-MartinHaahr, Vice President Clinical Pharmacology, Medicon A