Positive pre-clinical trial results for a Therapix Biosciences Ltd. (NASDAQ:TRPX) THC drug candidate sent shares of the cannabinoid pharmaceutical company flying in today's pre-market session.
Earlier this morning, Therapix, a clinical-stage pharmaceutical company focusing on the development of cannabinoid-based drugs, announced positive pre-clinical data generated in the company's development program for the treatment of Mild Cognitive Impairment, a.k.a. MCI. This is great news for the company since there is currently no FDA approved treatment for MCI.
Mild cognitive impairment is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. People with MCI, especially those involving memory problems, are more likely to develop Alzheimer's disease or other dementias than people without MCI.
Therapix's proprietary ultra-low dose THC drug candidate "THX-ULD01" significantly reversed age-related cognitive impairment in old mice. The pre-clinical animal study was designed and conducted by Professor Yosef Sarneof the Sackler Faculty of Medicine at Tel Aviv University in Israel.
"The data from this pre-clinical animal study suggest that extremely low doses of THC, which are devoid of any psychotropic effect and do not induce desensitization, could potentially provide a safe and effective treatment for cognitive decline in aging humans," remarked Professor Sarne.
In the study, old (24 month old) female mice were injected once with 0.002 mg/kg of THC, which is 3-4 orders of magnitudes lower than doses that induce the conventional cannabinoid effects in mice. These mice performed significantly better than vehicle-treated old mice, and performed similarly to naive young mice aged two months, in six different behavioral tests that measured various aspects of memory and learning. The beneficial effect of THC lasted for at least seven weeks.
Professor Sarne added, "the model demonstrated a relatively long-lasting increase in neuroprotection and neuroplasticity, as well as a larger volume and higher tissue density in various regions of the brain of THC-treated old mice as measured by MRI."
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, stated, "This promising data obtained by Professor Sarne and his team further demonstrate the clinical and commercial potential of THX-ULD01 for the treatment of MCI. Based on the discovery of significantly improved therapeutic impact at ultra-low doses (ULD) of THC, it is our continued belief that THX-ULD01 has the potential to fulfill the growing unmet medical need in MCI." Dr. Zuloff-Shani continued, "Further, this data echoes similar findings in pre-clinical models that demonstrate the neuroprotective role of ULD THC, which are expected to be followed by human trials for this potential first-in-class therapy."
Professor Sarne's scientific publication detailing these findings, titled, "Reversal of age-related cognitive impairments in mice by an extremely low dose of tetrahydrocannabinol," was recently accepted for publication in Neurobiology of Aging, and will be presented at the International Association for Cannabinoid Medicines' (IACM) 9th Conference on Cannabinoids in Medicine being held September 29-30, 2017 in Cologne, Germany.
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