- Announced that it has filed a Clinical Trial Application (CTA) with Health Canada for PhytoPain Topical Gel Relief (PPTGR), a locally administered therapeutic for the treatment of chemotherapy-induced neuropathic pain (CINP)
- Upon approval of the CTA, the Company plans to initiate a double-blind, randomized, cross-over, placebo-controlled clinical study with PPTGR in late 2016 and expects to report initial clinical data from the trial in late 2017
OTTAWA, ONTARIO–(June 15, 2016) – PhytoPain Pharma (PPP) Inc., a subsidiary of GrowPros Cannabis Ventures Inc. (“GrowPros” or the “Company” or “GCI“) (CSE:GCI), today announced that it has filed a Clinical Trial Application (CTA) with Health Canada for PhytoPain Topical Gel Relief (PPTGR), a locally administered therapeutic for the treatment of chemotherapy-induced neuropathic pain (CINP). Upon approval of the CTA, the Company plans to initiate a double-blind, randomized, cross-over, placebo-controlled clinical study with PPTGR in late 2016 and expects to report initial clinical data from the trial in late 2017.
CINP is a common adverse effect of cancer therapy and a frequent reason why cancer patients stop their treatment early. For some patients, the severity of the symptoms can be reduced by lowering the dose of chemotherapy or temporarily stopping it. In other patients, the symptoms of CINP may last for months or years after the cancer therapy has stopped. CINP symptoms are managed using the same analgesics used to manage other types of neuropathic pain. Some of these analgesics also cause intolerable side effects in patients. The use of a topical counterirritant may help reduce the symptoms of CINP and avoid exposing some patients to oral neuropathic pain analgesics.
According to Dr. Guy Chamberland, the Company’s Chief Scientific Officer, “PPP is developing this topical product to provide cancer patients a safer, natural and more tolerable alternative in the management of CINP”. The development of the PPTGR product is in line with PPP’s strategy to bring an integrative medical approach for cancer patients suffering from pain. “The demonstration of the safety and efficacy of botanical drugs including cannabis for pain management is a critical step in the development of an evidence-based approach to integrative medical care. PPP intends on working with physicians to demonstrate that PPTGR can be safely used as an adjunct to inhalation and oral medical marijuana for the reduction of pain in cancer patients. Physicians need additional drugs that can help reduce the amount of narcotics required to manage pain while minimizing the risk of psycho active effects or tolerance to opioids, cannabis, and other narcotics commonly prescribed to patients. The intention is to develop PPTGR, and other botanical-based drugs, as adjuncts to the standard of care,” stated Dr. Chamberland.
PPTGR is a counterirritant topical gel that conforms to the Natural and Non-prescription Health Products Directorate (NNHPD) monograph. However, the intended use of counterirritant products under the NNHPD monograph does not include the temporary relief of CINP. PPP is launching a clinical trial to demonstrate the safety and efficacy of PPTGR in cancer patients with CINP and work with medical oncologists to integrate the use of PPTGR in the management of CINP.
International research indicates that 60% of patients undergoing chemotherapy will suffer from varying degrees of CINP during their treatment. PPP believes it can demonstrate increased symptom alleviation using natural based agents and mixtures as opposed to the synthetic alternatives. “PPP was created to conduct cannabinoid and medicinal plant based research with the goal of developing over-the-counter products for consumers and prescription drug products for physicians that can be distributed through the existing pharmaceutical infrastructure. This submission is the first step in the growth of our vision,” commented CEO Ryan Brown.
CINP Market Size and comparison products
MARKET STATISTICS:
There were an estimated 15.2 million cancer cases globally in 2014 according to the International Agency for Research on Cancer (IARC) with projections of 17.1 million cases in 2020. Roughly 25%-30% of cancer patients receive chemotherapy, and of those patients, 70%-80% experience a form of CINP. The global CINP market saw estimated revenue of $1.3 billion in 2014 with a projected 5.7% compounded annual growth rate through 2020 as cancer rates climb with growing, aged populations. Of the products available Oral delivery drug of dronabinol which is comprised of synthetic cannabinoids had sales of $110M in 2014. Similar to other mainly orally administered cannabinoids, results in relatively low bioavailability, coupled with irregular pharmacokinetics secondary to absorption variability and first-pass metabolism by the liver, complicated by the need for multiple dosages per day. In addition, many patients report nausea and/or vomiting as a side-effect related to the drug. (NEMUS BIO SCIENCE)
Many studies have concluded that natural cannabinoids offer a safer, more effective solution than their synthetic counterparts. A recent article entitled Comparison of Outcome Expectancies for Synthetic Cannabinoids and Botanical Marijuana, from The American Journal of Drug and Alcohol Abuse, concluded that given growing public acceptance of recreational and medical marijuana, coupled with negative perceptions and increasing regulation of synthetic cannabinoid compounds, botanical marijuana is likely to remain more available and more popular than synthetic cannabinoids.
“PPP is proud to position itself as a leader in the development of natural pharmaceuticals derived Cannabis and other medicinal plants,” commented CEO Ryan Brown.
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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.
