- Entered into a clinical research partnership with Santé Cannabis
- Santé Cannabis will be working with PPP to develop the late phase clinical trial protocols that will be used to obtain substantial evidence of the safety and efficacy of PPP001 required for a new prescription drug approval from Health Canada and the USA Food and Drug Administration
- Ground-breaking trials seek to receive the first approval for a Canadian-manufactured cannabis-based prescription medication
OTTAWA, ONTARIO–(Jan. 23, 2017) – PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“TetraBio” or the “Company” or “TBP“) (CSE:TBP)(CSE:TBP.CN) is pleased to announce that it has entered into a clinical research partnership with Santé Cannabis. Under the partnership, Santé Cannabis will be working with PPP to develop the late phase clinical trial protocols that will be used to obtain substantial evidence of the safety and efficacy of PPP001 required for a new prescription drug approval from Health Canada and the USA Food and Drug Administration (“FDA“). These ground-breaking trials seek to receive the first approval for a Canadian-manufactured cannabis-based prescription medication.
Santé Cannabis is a private clinic specialized in the clinical application of medical cannabis for the treatment of pain and other chronic and terminal health conditions. The clinic’s team of physicians and support staff has unparalleled experience in the assessment and monitoring of medical cannabis patients. Santé Cannabis is the leading medical cannabis research institute in the province of Québec and the primary recruitment site for the province-wide Quebec Cannabis Registry. “Our clinic has provided services to almost 2,000 patients referred by over 1,500 physicians across Québec,” states Erin Prosk, Director of Santé Cannabis. “It is clear that both the medical community and the Quebec patient population are in desperate need of information about the potential benefits and risks of medical cannabis treatments. The status of medical cannabis as an unapproved treatment dissuades many physicians from writing a prescription and requires patients to pay for treatments out of pocket. Of the 2,000 patients that we have seen, there is not one who is not burdened by this financial barrier.”
Dr. Antonio A.L. Vigano, MD, MSc, will lead the Santé Cannabis team to administer the Phase II-III clinical trials in close collaboration with Dr. Irina Kudrina, MDCM, CCFP, CSP, and Santé Cannabis Medical Director Dr. Michael Dworkind, MD, CCFP, FCFP. Dr. Vigano is an attending physician in the Supportive and Palliative Care Service at the McGill University Health Centre and an Associate Professor in the McGill University Department of Oncology. He is the Director of the McGill Nutrition and Performance Laboratory and the Cancer Rehabilitation (CARE) Program. Dr. Vigano has assessed and followed approximately 400 patients during his 18-month tenure at Santé Cannabis. “It has become clear that medical cannabis can be a critical complementary therapy for the treatment of pain,” states Dr. Vigano. “Administering these late phase clinical trials is necessary to rigorously validate the efficacy and tolerability that I observe every day with my patients at Santé Cannabis. If specific medical cannabis products and protocols such as that we will design for PPP001 can withstand the pharmaceutical approval process, it cannot be denied as a valid pain therapy. Cost-coverage should be a logical next step.”
Dr. Irina Kudrina is a McGill-certified pain physician and an attending physician and head of the chronic pain services at the Queen Elizabeth GMF-U and Assistant professor and clinician-researcher at the McGill University Department of Family Medicine. “At present, medical cannabis has already become an important medicine in the fields of oncology, chronic pain, neurology and others. In a clinical review* published in Journal of the American Medical Association (2015), Harvard-based researchers highlighted its use in some medical conditions as being supported by high quality evidence. In Canada, the efforts by regulatory, medical, and pharmaceutical bodies and by the patient advocacy movements have been targeting multiple structural, legal and information barriers still prevailing from the times when long-term high dose opioid therapy was prescribed to chronic pain patients despite its chronic toxicity effects and without high quality evidence for such use. While the clinical use of medical cannabis remains a stigmatized and poorly researched option for some medical conditions, sufficiently large-scale late-phase clinical trials on efficacy, safety and tolerability of medical cannabis are long overdue. These studies might open the door for another class of medications in an attempt to fill the current significant gap for more long-term pharmacological options.”
*(https://www.ncbi.nlm.nih.gov/pubmed/26103031)
PPP entered into this partnership because of Santé Cannabis’ unique expertise and dedication to a pharmacovigilance approach in medicine. The clinic has established clinical practices that help minimize adverse effects in patients and will help design the treatment protocols for the Phase II-III studies. According to Dr. Guy Chamberland, Chief Scientific Officer and Regulatory Affairs, “Adequately designing a late phase clinical trial for the evaluation of the safety and efficacy of inhaled Cannabis requires clinical teams experienced in handling the administration of Cannabis by inhalation to patients. The medical experts of Santé Cannabis complement the scientific and medical experts of our Clinical Advisory Board and provide PPP with an exceptionally solid foundation for the clinical development of Cannabis products as prescription drugs.”
Once authorized by Health Canada, Santé Cannabis will be recruiting participating physicians and patients from the Montreal area throughout 2017. For more information, please contact the clinic by email at [email protected].
About Santé Cannabis:
Santé Cannabis is Québec’s only medical clinic and resource centre dedicated to the clinical practice and research of medical cannabis treatments. Since opening in November of 2014, physicians at Santé Cannabis have assessed almost 2,000 patients referred by more than 1,500 physicians across the province of Québec. Santé Cannabis currently administers several clinical study protocols, including the Québec Cannabis Registry in collaboration with the Research Institute of the McGill University Health Centre and in accordance with the regulations of the Collège des Médecins du Québec.
The Canadian Securities Exchange (CSE) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
