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Clinical Trials and Advanced Development of Innovative Drug Treatments Boosting Biotech Sector Gains

The new-drug pipeline is bursting with innovative treatments in clinical trials while the industry is growing by leaps and bounds. Many biotech stocks are catching the attention of Wall Street as new milestones and major developments are being achieved at a faster pace. The pipeline of new drugs of all kinds has exploded. According to, more than 1,480 drugs filed for Phase 3, or late-stage, trials with the U.S. Food and Drug Administration this year, and the FDA has more than 32,000 late-stage studies registered. The SPDR S&P Biotech ETF (XBI) has gained over 45 percent in 2017 to its highest level in more than two years leaving a few industry experts to believe the climb isn’t over just yet for biotech leaders such as: Therapix Biosciences Ltd. (NASDAQ: TRPX), Medtronic plc (NYSE: MDT), Koninklijke Philips N.V. (NYSE: PHG), Teva Pharmaceuticals (NYSE: TEVA), Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE).
Therapix Biosciences Ltd. (NASDAQ: TRPX), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, signed an agreement with Assuta Medical Center, the largest hospital network and private healthcare provider in Israel, to conduct a Phase IIa, sponsor-initiated trial (the “OSA Trial”) for the treatment of Obstructive Sleep Apnea (“OSA”) using the Company’s proprietary cannabinoid-based technology, THX-OSA01.
The OSA trial, titled “Examining the Efficacy of a Therapeutic Combination of Dronabinol (synthetic ?9-tetrahydracannabinol) and Palmitoylethanolamide for Obstructive Sleep Apnea,” will be conducted under the leadership of Professor Yaron Dagan, head of the Sleep Medicine Institute at Assuta, and Principal Investigator, Dr. Lilach Kemer. Thirty patients with a confirmed OSA diagnosis will be evaluated for one month with the primary efficacy endpoint evaluating a significant change in the AHI Index, which assesses the quality of sleep before and after treatment.
Professor Dagan said, “Breathing sleep disorders affect a substantial and growing percentage of the adult population. Currently, the standard treatments for obstructive sleep apnea (OSA) are noninvasive ventilation devices (CPAP) and oral appliances that are very inconvenient to the patient, thus result in low compliance. There are currently no approved pharmaceutical approaches. As such, we are enthusiastic to be working with Therapix in its development of a potentially transformational therapy in this area of high unmet medical need.” Dronabinol, one component of THX-OSA01 and an exogenous CB1 and CB2 receptor agonist, has been shown in a proof-of-concept study by an independent group to potentially reduce abnormal respiratory events and associated hypoxemia in patients with OSA. In a study, conducted by researchers from the department of medicine at the University of Illinois, Chicago, in 17 adults with moderate-to-severe OSA, dronabinol significantly reduced the apnea-hypopnea index (“AHI Index”).
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, said, “We are excited to collaborate with Professor Dagan, a recognized key opinion leader and world-renowned expert in sleep medicine. A main point of interest in this trial will be investigating the power of the ‘entourage effect,’ which we have previously observed in our proprietary compound in other indications, to enhance the treatment of OSA. We believe the benefits of this effect, in which the two cannabinoids, tetrahydracannabinol (THC) and palmitoylethanolamide (PEA) work synergistically, ensure this trial will expand our knowledge of the utility of THX-OSA01 as a potential OSA treatment.” Josh Blacher, Chief Financial Officer of Therapix, said, “In addition to the potential commercial opportunities we believe may lie ahead of us in our proprietary treatments for Tourette syndrome and Traumatic Brain Injury, our exploration of the OSA market is a third indication that may have potential to be commercialized in the future if our clinical trials are successful.”