CALGARY, March 16 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. (SCT) is pleased to report positive results from its Phase I pharmacokinetic clinical trial in support of its lead therapeutic program for stroke, NTx(TM)- 265. The trial demonstrated that, for the two drugs administered to healthy volunteers, no drug related adverse events were encountered and both drugs were detected in the cerebrospinal fluid (CSF) following intramuscular administration. The study was conducted on SCT’s behalf by Medicon A/S of Birkerod, Denmark.
This Phase I clinical trial permitted characterization of the relationship between intramuscular administration, passage into blood and subsequent transport into the CSF. The study also generated new evidence that these two neural stem cell (NSC) proliferation inducing drugs reach the CSF when administered to human subjects with an intact blood-brain barrier.
The results of this clinical trial demonstrate that: - No drug related adverse events were observed for either NSC proliferation inducing drug at the administered dose; - Transport of the two different NSC proliferation inducing drugs into the CSF was detected in healthy subjects. - When comparing the two NSC proliferation inducing drugs, there was no statistically significant difference in the pharmacokinetic distribution or transport of drug into the blood and CSF;
“The completion of this Phase I clinical trial is an important step for Stem Cell Therapeutics and in the development of the NTx(TM)-265 therapeutic program”, said Dr. Joseph Tucker, President & CEO. Dr. Tucker continued, “With this information in hand we feel supported in our decision to move forward with planning a Phase IIa clinical trial, to be conducted in patients suffering from stroke, in the near future”.
The Phase I clinical trial investigated and compared the pharmacokinetic profile of two of the approved and on market forms of the NSC proliferation inducing drug. The primary aim of this trial was to demonstrate that intramuscular administration of either of the two drug forms results in the passage of drug into the blood and then subsequently on into the cerebrospinal fluid (CSF) in age-matched healthy, human volunteers. As NSCs in the adult human brain are in close proximity to the CSF, drug transport into the CSF would support SCT’s planned therapeutic strategy of providing drugs by peripheral administration in order to achieve benefit in the brain. Healthy subjects are expected to have an intact blood brain barrier and therefore permit less transport of drug from blood to the CSF than occurs in stroke patients. This limited transport occurs because stroke patients experience a transient loss of integrity of the blood brain barrier following acute onset of the disease.
The administered dose of the two different drug forms was similar to that planned for future clinical studies in stroke patients. As the volunteers in the Phase I trial were healthy and had not suffered a recent stroke, there was no possibility of deriving data to demonstrate efficacy and therefore no efficacy endpoints were included in the Phase I trial’s design.
Stroke is the third leading cause of death in the United States, where it affects 700,000 people each year, and is the second leading killer worldwide. Stroke is also the leading cause of long-term disability. The American Heart Association estimates that death and injury due to stroke cost the US economy $56.8 billion in 2005.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two drugs being developed by SCT for the treatment of stroke. The first drug administered in the regimen increases the number of NSCs located in the brain of a patient suffering from a recent stroke, which is accomplished by the systemic administration to the patient of an NSC proliferation inducing drug. There are several potentially useful versions of the proliferation inducing drug available and from amongst which SCT has the option to choose. Some of these versions are already approved and on market while other versions have not yet been approved for clinical use. The second drug administered in the regimen promotes the differentiation of these newly formed NSCs into new neurons. New neurons thus formed are anticipated to provide benefit to the patient through the replacement of the brain cells that were lost or damaged by the stroke. The differentiation step is achieved by administration of a differentiation inducing drug, one of several forms available, some approved and some not yet approved.
About Medicon A/S: Medicon A/S is a 20 year old drug development organization with a documented success in clinical research with scientific impact and with a track record of high quality trials. With their specialists team they offer fast track solutions within all services for phases I-IV studies, from synopsis to final report, 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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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, info@stemcellthera.com; for furtherinformation on Medicon, visit www.medicon.dk or contact: Dr. Poul-MartinHaahr, Chief Executive Officer, Medicon A/S, Phone: +45 7020 2058,pmh@medicon.dk
