Stem Cell Therapeutics' study supports peripheral administration of drugs meant for the brain

By Elaine Rigoli

Tampa, Fla., March 16 - Stem Cell Therapeutics Corp. said results from its phase 1 clinical trial of NTx-265, its therapeutics two-drug regime for the treatment of stroke, showed no drug-related adverse events and found that both drugs were detected in the cerebrospinal fluid following intramuscular administration.

The study also generated new evidence that the two neural stem cell proliferation-inducing drugs in the NTx-265 regime reach the cerebrospinal fluid when administered to human subjects with an intact blood-brain barrier, according to a company news release.

The phase 1 clinical trial investigated and compared the pharmacokinetic profile of two of the approved forms of the neural stem cell proliferation-inducing drug.

When comparing the two neural stem cell proliferation-inducing drugs, there was no statistically significant difference in the pharmacokinetic distribution or transport of drug into the blood and cerebrospinal fluid, the company said.

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 in age-matched healthy, human volunteers.

As neural stem cells in the adult human brain are in close proximity to the cerebrospinal fluid, drug transport into the cerebrospinal fluid would support Stem Cell's planned therapeutic strategy of providing drugs by peripheral administration in order to achieve benefit in the brain, according to the release.

Healthy subjects are expected to have an intact blood brain barrier and therefore permit less transport of drug from blood to the cerebrospinal fluid 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.

"With this information in hand we feel supported in our decision to move forward with planning a phase 2a clinical trial, to be conducted in patients suffering from stroke, in the near future," Joseph Tucker, president and chief executive officer, said in the release.

Stem Cell Therapeutics is a biotechnology company located in Calgary, Alta., focused on the development of its technology platform to selectively induce a patient's own stem cells to proliferate in the brain.

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