Tetra Bio-Pharma (OTCQB:TBPMF; CSE:TBP) has an aggressive clinical trial program set to begin in the final quarter this year and first quarter of 2018 to prove the efficacy and safety of at least three therapeutic cannabis products.
“We’re also hoping to launch a line of natural health cannabis products by the fall this year to begin generating revenue,” Andre Rancourt, CEO, says in an interview with BioTuesdays.
Those natural health products include a topical treatment for pain management; an oral well-being product designed for cardiovascular disease prevention and athletic performance; a topical cream for skin care; and a quality of life topical for women, he adds. “We’ve hired a VP of sales and marketing to work on branding and distribution.”
Founded in 2015, Tetra operates through three subsidiaries, including Phyto Pain Pharma, a developer of cannabis-based drug products; Agro Tek, its commercialization arm for natural health products; and Grow Pros, a landowner proceeding with plans to become licensed to grow marijuana.
“We are planning to sell Grow Pros because we do not want to be known as a recreational marijuana company, but rather as a global leader in pharmaceutical cannabis and nutraceuticals,” Mr. Rancourt points out. “Cannabis-based drugs have the potential to replace drugs that have toxic side effects, such as steroids.”
Canada currently has 43 licensed producers of cannabis and Mr. Rancourt suggests that medical marijuana is an industry that has popped up based on casual studies observing the benefits of smoking marijuana.
“Our strategy is to focus on the real science and safety of cannabis so that our products can be approved by Health Canada and the FDA, prescribed by physicians, distributed by pharmacies and covered by insurance companies.”
Tetra is developing its lead product, PPP001, to be the first smokeable marijuana for advanced cancer pain. PPP001 has been designed as a pellet to be delivered through a titanium inhalation device, which includes a digital readout so that a pharmacist can monitor an individual’s consumption of cannabis.
Tetra has a strategic partnership with Aphria (OTCQB:APHQF; TSX:APH), a leading licensed producer of cannabis, which is supplying the active pharmaceutical ingredient for PPP001.
Last month, Tetra reported positive results from a Phase 1 study of PPP001, with safety data meeting the company’s expectations. In addition, pharmacokinetic data demonstrated that inhalation of PPP001 achieved the targeted plasma levels of tetrahydrocannabinol (THC) that could potentially achieve pain relief in cancer patients.
The Phase 1 trial also provided key information required to design a Phase 3 clinical trial for cancer patients, which is expected to begin around the end of this year. “Because cannabis is a known chemical entity, we are able to bypass Phase 2 studies and move directly into a pivotal trial,” Mr. Rancourt points out.
The company hopes to sign a commercial partnership for PPP001 by the end of 2018 and receive a Notice of Compliance from Health Canada by the end of 2019 to launch PPP001, he adds.
In Canada, under the Access to Cannabis for Medical Purposes Regulations (ACMPR), which permits compassionate use of cannabis, Tetra hopes to begin selling PPP001 through pharmacies at the end of the summer.
“We will be able to use this legal route to generate revenue,” Mr. Rancourt notes.
In addition to pain relief, Tetra expects to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. “Our clinical program also will address the potential of PPP001 to reduce the reliance on opioids for management of severe pain,” he adds.
Tetra and IntelGenx (OTCQX:IGXT; TSXV:IGX) are jointly developing an oral mucoadhesive dronabinol XL tablet, known as PPP002, which clings to the inside of the cheek and is based on IntelGenx’s AdVersa controlled-release technology.
“The sustained-release THC tablet has the potential for a significant reduction of side effects, compared with synthetic THC, for North American patients suffering from anorexia and cancer chemotherapy-related pain,” Mr. Rancourt says.
Tetra also plans to develop cannabinoid drugs for the veterinary market and plans to create an advisory board consisting of veterinary specialists in the fields of ophthalmology, oncology and pain.
A Phase 1 study of PPP002 has been successfully completed, with a Phase 2 trial slated to begin in the fourth quarter this year, leading to a Phase 3 trial by the end of 2018.
Tetra hopes to meet with the FDA’s Division of Anesthesia, Analgesia, and Addiction Products to discuss a 505(b)(2) regulatory filing of PPP002 and marketing requirements for the Dronabinol XL AdVersa Mucoadhesive tablet.
For dry eye disorder, ocular pain and inflammation, Tetra and co-development partner, Panag Pharma, have completed preclinical proof-of-concept and non-clinical safety of a cannabinoid eye drop, known as PPP003.
Tetra hopes to begin Phase 1 testing of PPP003 at the end of this year in patients with dry eye, which Mr. Rancourt suggests is the most rapid indication for drug approval.
Tetra and Panag also are developing a pure THC topical cream, currently known as PPP004, for the treatment of general neuropathic pain, such as exema.
“We focus our business model on developing partnerships to take advantage of the proven technology other companies have developed and then working jointly to bring pharmaceutical relevance to these cannabis-based drugs,” he says.