Stem Cell Therapeutics’ ischemic stroke drug NTx-265 is undergoing patient studies in India

Stem Cell Therapeutics Corp has received final approval to begin patient studies using its new stem cell therapy NTx-265 for ischemic stroke, the company announced.

The Data Safety Monitoring Board (DSMB) has completed its third and final regularly scheduled safety analysis recommended for the Phase IIb acute ischemic stroke trial to continue as per protocol.

The DSMB is a group of independent clinical experts that review the ongoing conduct of a clinical trial to ensure continuing patient safety. The mandate of SCT’s DSMB is to provide objective, independent monitoring of patient safety during the Phase IIb acute ischemic stroke trial.

NTx-265 for ischemic stroke is already underway in India.

Drug Controller General of India (DCGI) gave approval for  NTx-265 for ischemic stroke protocol on July 21, 2009 issuing the company a No Objection Letter (NOL) for the same protocol.

The clinical trials NTx-265 for ischemic strokeare being conducted in India, Canada and the U.S.

96 patients have been enrolled to-date in Stem Cell Therapeutics’ modified REGENESIS Phase IIb acute ischemic stroke study.

Stem Cell Therapeutics expects Phase IIb patient enrollment to be complete by the end of Q1 2010 and for top-line data to be available after the 90-day patient assessment review period is complete, approximately by the end of Q2 2010.

“We continue to anticipate that patient enrollment for the Phase IIb stroke trial will be complete by the end of Q1 2010 and for top-line data to be available after the 90-day patient assessment review period is complete, approximately by the end of Q2 2010,” stated Dr. Alan Moore, president and CEO of Stem Cell Therapeutics in a media release.

Stem Cell Therapeutics conducted animal studies that showed a significant recovery in motor function in animals that received a stroke followed by the NTx-265 therapy.

On April 10, 2007, Stem Cell Therapeutics released interim results from the BETAS Phase IIa acute ischemic stroke trial and on February 20, 2008 SCT released further results from the BETAS trial, both of which showed positive outcomes.

Enrollment of the first patient in its original REGENESIS Phase IIb stroke trial began on May 28, 2008.

Enrollment in the U.S. Phase IIb study was expected to begin in Q4 2008 and finish in Q2 2009. Due to an unrelated German clinical study, the REGENESIS Phase IIb clinical trial was officially placed on clinical hold in September 2008 at the request of Health Canada and the U.S. Food and Drug Administration.

At the time the clinical hold occurred on the REGENESIS Phase IIb stroke trial, 7 patients had been enrolled in the study. The clinical hold was formally lifted by the FDA on May 14, 2009.

Health Canada approved the modified REGENESIS Phase IIb stroke trial on July 20, 2009.

On May 21, 2009 Stem Cell Therapeutics announced encouraging results from the original 7 patients enrolled in the trial prior to the clinical hold. The results of the Phase IIb trial from the 7 patients indicated an improvement in the treated group as compared to the placebo group.

Of the 7 patients enrolled, 5 received placebo and 2 were treated with NTx-265. A decrease in the NIHSS score represents an improvement in a patient’s functionality. A change of 4 units in the NIHSS scale is considered clinically significant.

NTx-265′s modified REGENESIS Phase IIb double-blind, randomized, placebo-controlled clinical stroke trial will involve approximately 128 stroke patients in a number of different centers in India, Canada and the U.S.
In regard to the traumatic brain injury clinical trial, Stem Cell Therapeutics continues to work with Dr. David Zygun from the Department of Critical Care at the University of Calgary, Foothills Medical Centre. The Phase IIa TBI clinical trial is expected to begin enrolling patients in the first half of this year, he added.

Stem Cell Therapeutics Corp. is a public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.

Stem Cell Therapeutics is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells.

The company’s drugs aim to repair brain and nerve function lost due to disease or injury.

The company plans clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.

What is ischemic stroke?

A human stroke can be compared to a heart attack but located in the brain.

After an acute ischemic injury (stroke), brain tissue dies quickly in the absence of gas and nutrient exchange and has a limited capacity to spontaneously repair, regenerate or regain lost functionality.

For this reason, injury due to stroke is frequently irreversible, recovery is insufficient and extensive recovery periods that range from months to years accompanied by intensive physiotherapy are required.

Moderate to severe acute ischemic stroke is accompanied by the loss of a large number of neural cells within a patient’s brain. Loss of brain matter is accompanied by a varied array of symptoms including loss of cognitive function, loss of motor control to one side or both sides of the body, loss of visual and other symptoms.