Preclinical studies: Autism compound, KM-391, significantly decreased plasticity of the brain and increased serotonin levels


Cellceutix is developing an experimental drug, KM – 391, to treat autism.  Cellceutix, is a biopharmaceutical company developing small molecule drugs to treat diseases like Autism, Psoriasis and Cancer. To read a report, which includes a link to listen to an interview with the CEO of Cellceutix, Leo Ehrlich, by The Street Beat on April 26 & 27, 2012, with Bolton Flautt, click here.  To read the article on the small molecules being developed by Cellceutix by Len Zehr in Seeking Alpha click here.

KM-391Clinical Trial Data in Animals

Preclinical studies have shown that administration of the autism compound, KM-391, significantly decreased plasticity of the brain and increased serotonin levels in all three regions of the brain: cerebral cortex, hippocampus, and caudate nucleus, from very low levels, as seen with 5, 7-Dihydroxytryptamine (5, 7-DHT)-induced autism, to normal levels, as observed in placebo-treated control without the neurotoxin 5, 7-DHT.

Cellceutix recently acquired the small molecule technology and began preclinical trials in animals. They conducted three studies, which you may click here to read in detail on Cellceutix site. It includes:
1. Summary of the first animal studies with KM-391
2. KM-391 second study at a prestigious research institute in India
3. KM-391 Third Study – Serotonin Levels Measured in Three Different Regions of the Brain.

Second animal study – Autism 391

“These results support KM-391 as a possible therapeutic agent in the treatment of autism in patients,” Mr. Ehrlich contends. “If we can deal with the core issues of autism and not just the symptoms of the disease, it would be a major breakthrough and offer hope to families and patients who suffer from autism.”

Based on results from a third animal study showed KM-391 was a possible therapeutic agent in the treatment of autism in patients, CEO Leo Ehrlich says Cellceutix is working on possible collaborations to further develop the autism compound, which can be quite expensive.  It has a memorandum of understanding with a company in India, able to financially support and implement all the pharmacology, preclinical work, including cGMP manufacturing, and toxicology, in compliance with U.S. IND requirements.

On November, 2011 announced Cellceutix Chief Scientific Officer Dr. Krishna Menon, “We are extremely pleased to add Dr. Marks to our team. We have assembled a world-class advisory board with Dr. Emil Frei, Dr. Samuel Danishefsky, Dr. Paul Ginsburg and now Dr. Paul Marks. Going forward with Kevetrin™ in clinical trials, as well as other drugs in our pipeline, their experience and knowledge will play a key role in our success”. Dr. Marks served as President and Chief Executive Officer of Memorial Sloan-Kettering Cancer Center (“MSKCC”) from 1980 to 1999. His addition to the board shows the firms commitment is towards their cancer drug, also currently in the pipeline.

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