Clinical Trials and Advanced Development of Innovative Drug Treatments Boosting Biotech Sector Gains
PALM BEACH, Florida, October 18, 2017 /PRNewswire/ --
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 Clinicaltrials.org, 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. Read this entire release and more news for TRPX at: http://www.marketnewsupdates.com/news/trpx.html
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."
In other industry news and market performance of note:
Medtronic plc (NYSE: MDT) closed up slightly on Tuesday with over 3.8 million shares traded by the market close. The company recently announced its Medtronic Care Management Services (MCMS) business and American Well(R) entered into a first-of-its-kind strategic partnership to enable a more complete telehealth solution focused on the unique needs of the complex, chronic, co-morbid patient population. Under the terms of the agreement, the businesses will work together to enable patient access to American Well`s telemedicine services on MCMS` video-enabled platforms, and to allow bi-directional data flow between the two parties. The telehealth solution will provide information from MCMS` remote patient monitoring to clinicians performing consultations using American Well`s telemedicine capabilities, and enable information from these telemedicine visits to be included in MCMS`clinical management software.
Koninklijke Philips N.V. (NYSE: PHG) - Royal Philips, recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new eL18-4 transducer with full solution for 'small parts' assessment, which is an ultrasound exam to detect abnormalities in the small organs that are close to the skin. The Philips Ultimate Small Parts Solution features four key innovations that work together to help improve patient care: the eL18-4 PureWave linear array transducer, Philips MicroFlow Imaging, Philips Elastography and Philips Precision Biopsy. The new eL18-4 transducer can also be used to assess musculoskeletal injuries. Philips will debut this latest solution, which is available on Philips EPIQ 7 and 5 and Affiniti 70 ultrasound systems, at the 16th World Federation for Ultrasound in Medicine and Biology (WFUMB) Congress in Taipei.
Teva Pharmaceutical Industries Limited (NYSE: TEVA) closed up slightly on Tuesday at $14.74 trading over 14.5 million shares by the market close. TEVA recently announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. "The BLA submission for fremanezumab marks a very important milestone for the migraine community," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva.In Cannabis developments for TEVA, an Israeli canna-business is bringing the world's first metered-dose cannabis inhaler to market, allowing doctors to provide patients with exact doses of medical marijuana in a controlled setting. Tel Aviv-based Syqe Medical announced a partnership with pharmaceutical firm Teva Pharmaceuticals to bring their new 3D-printed cannabis technology to the worldwide market. The metered-dose inhaler has several advantages over traditional medical cannabis products, including the ability to provide an exact dosage. A dose of concentrated cannabis vapor from the device can take full effect in three to five minutes, a substantial improvement on oils or edibles, which can take hours to be fully absorbed by the body.
Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutically-produced transdermal cannabinoid treatments, a few weeks ago announced positive top line results from an open label exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The study successfully met its primary endpoint, achieving a 46% improvement (p<0.0001) in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which address the key symptoms of FXS including social avoidance, temper tantrums, repetitive movements, and hyperactivity.
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