PPP001 - Phase III approval is a HUGE dealIf you don't really understand what Tetra Bio Pharma (TBP) is trying to accomplish, and you haven't put together the puzzle pieces yet, this post will be of great service to you and your investment dollars.
I know some investors are hesitant to invest in a "bio-pharmaceutical" company because they fear the immense loss in investor confidence that occurs when their lead drug does not get approval at the end of their lengthy clinical trials. Just to remind you, this is the name of the study that PPP001 is currently undergoing: Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients
While you're here, you might as well read the description of the study. "Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions." Does anyone doubt that smoking PPP001, which is a tri-blend of ground cannabis crafted by Master Herbalist Guy Chamberland, will improve the quality of life in terminal cancer patients? Did you already forget, or were you unaware that they had a successful Phase I trial? "After a detailed review of the clinical data, the Company is pleased to announce that the safety data met its expectations and that the pharmacokinetic data demonstrated that the inhalation of PPP001 achieved the targeted plasma levels of THC that could potentially achieve pain relief in cancer patients. The Phase I trial provides the key information required by the medical experts of Sante Cannabis to design a Phase III clinical trial for cancer patients. The Company expects to launch the Phase III clinical trial by Q4/17 - Q1/18.
The development of PPP001 for patients with advanced cancer is an important commitment for Tetra. Cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical marijuana has been shown to help patients beyond the immediate benefit of pain relief. With the expertise of Sante Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. Importantly, our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. The Company will continue to maintain a transparent and direct line of communication with Health Canada (Therapeutic Products Directorate and Controlled Drug Substances) and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first," commented Dr. Chamberland CSO of Tetra Bio-Pharma." You may have thought that it would just end at being marketed for advanced cancer pain, right? Well feast your eyeballs on this following news release excerpt: "Tetra Bio-Pharma Inc. ("Tetra" or the "Corporation") (TSX VENTURE:TBP)(OTCQB:TBPMF),today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the active ingredients of its PPP001 drug (delta-9-tetrahydrocannabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome (CRPS). The Orphan Drug Designation was granted for the active moiety of the drug PPP001 and not the formulation.
The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect less than 200,000 people in the USA. This designation gives Tetra a seven-year marketing exclusivity, after drug approval by the FDA, and provides Tetra potential incentives such as access to federal grants and tax credits as well as a waiver of Prescription Drug User Fee Act filing fees.
Tetra successfully completed a placebo-controlled Phase 1a and 1b study of PPP001 in healthy volunteers and demonstrated that PPP001 can be safely consumed. "We are pleased to receive FDA Orphan Drug Designation for PPP001 and we look forward to discussing the clinical program with the US FDA that will be used to demonstrate the safety and efficacy in patients suffering from CRPS," said Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer of Tetra.
According to the USA National Institute of Health, "complex regional pain syndrome (CRPS) is a chronic pain condition that most often affects one limb (arm, leg, hand, or foot) usually after an injury. CRPS is believed to be caused by damage to, or malfunction of, the peripheral and central nervous systems. CRPS is characterized by prolonged or excessive pain and changes in skin color, temperature, and/or swelling in the affected area."
And then later this year, another disease for PPP001 to be marketed towards:
"ORLEANS, Ontario, July 16, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF), today announced a co-development agreement with Storz & Bickel to use a specialized medical device known as the Mighty Medic, in combination with its PPP001 prescription drug as well as with additional indications and a future proprietary cannabinoid formulation. The Mighty Medic is a portable herbal vaporizer for cannabis use approved by Health Canada as a Class 11 medical device and as such, is eligible for reimbursement. The agreement allows Tetra to effectively bring PPP001 to patients suffering from fibromyalgia and other chronic pain conditions, significantly expanding the market potential for PPP001.
Fibromyalgia affects about 4 million U.S. adults or about 2% of the adult population1. The cardinal symptom associated with the condition is pain that can be deep, sharp, dull, throbbing, or aching, affecting the muscles, tendons, and ligaments around the joints throughout the entire body. Treatments aimed at pain relief are the primary treatment intervention including an increasing use of opioids. Among the most commonly prescribed medications used to treat fibromyalgia are Lyrica, Cymbalta, Xyrem and Vimpat.
PPP001 is a cannabinoid-based product that is currently being studied in a Phase 3 Health-Canada approved clinical trial for advanced cancer pain. Tetra will use a bridging strategy to leverage the clinical data that has been generated with the smokable formulation of PPP001, to expedite the marketing requirements in these indications and reduce the time needed to bring these products to market. The combination product of PPP001 with the Mighty Medic would signify an important economic benefit for patients.
According to Dr. Gordon D. Ko, MD, FCFP(EM), FRCPC, PhD, “fibromyalgia is difficult to treat and there is no one "magic bullet". As practitioners we have the daunting task of moving our patients from unrelenting neuropathic pain to improved function and a better quality of life,” said Dr. Ko. “The clinical use of medical cannabis in the management of fibromyalgia suggests these patients obtain significant relief. Moreover, the potential to reduce opioid use for these patients is a foremost consideration of using the Mighty Medic to deliver the cannabinoids and terpenes contained in PPP001 by inhalation.” Dr. Ko is Medical Director, Fibromyalgia clinics and Adjunct Lecturer at The Canadian Centre for Integrative Medicine, (Markham, Ontario) and Sunnybrook Health Sciences Centre, University of Toronto.
As a prescription drug, PPP001 will be eligible for insurance coverage. In Canada, only Class II, III and IV medical devices are eligible for reimbursement under provincial health care insurance programs.
Tetra and Storz & Bickel will also collaborate on the development of another inhalation cannabinoid-based prescription drug. The drug device combination product will target cancer patients and Tetra will use a similar bridging strategy to minimize marketing requirements and reduce time-to-market." Now, if you still don't think it's a certainty that they will successfully complete their Phase III trials and gain FDA/Health Canada approval to market PPP001 for a multitude of ailments, then I would advise you to take a few minutes and watch this video about a cancer patient whose life was essentially stolen from him due to the frequent use of opiods for pain relief. https://www.youtube.com/watch?v=_eAXRLty5e4&t=151s
Everything else this company is working dilligently to accomplish is gravy. The approval of PPP001, quite honestly, going to be a boon for investors and I look tremendously forward to that day.