Approximately 60 patients suffering breakthrough cancer pain will participate in a clinical trial that compares fentanyl medication with an inhaled medical cannabis product developed by Tetra Bio-Pharma.
Rapid-onset opioids are the standard treatment for breakthrough cancer pain, which comes on quickly and is extremely intense.
Tetra Bio-Pharma said clinical data already shows that its lead drug, PPP001, can bring rapid relief and may even be a faster-acting alternative to opioid fentanyl.
Led by McGill University professor Antonio Vigano, MD, and in collaboration with Sante Cannabis, the study is expected to start in December, with recruitment to follow.
As a prescription drug with a Drug Identification Number, Tetra’s cannabis-based medication will be eligible for insurance coverage and be accessible in pharmacies.
The company recently announced Health Canada approval for a phase 1 clinical trial that will allow it to take the next step in commercializing its vaporized cannabis drug.
Health Canada’s decision to reclassify the vaporizer as a Class Two medical device makes it eligible for cost reimbursement from private and public-insurance plans.
APHRIA CEO sees “enormous opportunity”
Canadian cannabis company Aphria owns 10-million common shares of Tetra, and its CFO serves on Tetra’s board of directors. It also has a supply contract with the company, for two products: a compressed dried-flower product (PPP001); and an oil-based product (PPP005) that is delivered with a syringe in the mouth.
Aphria CEO Vic Neufeld, during the company’s quarterly update last month, told investors:
“We see enormous opportunity for our relationship with Tetra, both as a supplier and as a shareholder.”
A head-to-head study on pain management for PPP001 against Fentanyl is one of the “many interesting trials going on,” he said.
The drug is currently in Phase 3, said Neufeld, with the end goal being a Drug Identification Number.
Tetra and its clinical research partner Santé Cannabis are the first in North America to make substantial progress on a clinical trial using cannabis-oil capsules to treat chronic pain that is not related to cancer.
It’s the first-ever and most exhaustive study to evaluate the safety and efficacy of different doses and ratios of cannabis oils versus placebo.
The company said the clinical trial is on track to be completed this fall, with important information already coming in.
It is also accelerating work to bring PPP001to market for fibromyalgia patients.
Tetra is also awaiting decisions on multiple Orphan Drug Designation submissions to the U.S. Food and Drug Administration for products to treat rare cancers and ocular diseases.
LUCRATIVE MARKET FOR PAIN RELIEF PRODUCTS
Tetra recently secured a new supply agreement with True North for high-quality, competitively priced CBD.
Through its agreement with Genacol Canada, the company plans to get its oral capsule and topical cream into the $2.5-billion market for joint-pain-and inflammation products.
OPPORTUNITY IN EUROPE
Last fall, the company said it intends to pursue a Full Market Authorisation for the registration of its cannabis drugs under Directive 2001/83/EC of the European Parliament
The directive gives the company the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs.
Tetra Bio-Pharma has several subsidiaries engaged in the development of an advanced and growing pipeline of bio pharmaceuticals, natural health and veterinary products containing cannabis and other medicinal plant-based elements.
The company recently launched a Hemp Energy Drink from Kombucha Baby Brewing Company.