Medical marijuana research firm Tetra Bio-Pharma announced its trial for PPP001 was back in place after a review from the FDA.
A medical research cannabis company has obtained a critical approval for its investigation of a drug to treat uncontrolled pain in advanced cancer patients.
On Monday (November 25), Tetra Bio-Pharma (TSXV:TBP,OTCQB:TBPMF) informed its shareholders the US Food and Drug Administration (FDA) approved the reopening of a clinical trial for PPP001, also known as Qixleef, for pain management in patients with cancer.
In an exclusive interview with the Investing News Network (INN), Guy Chamberland, CEO and chief regulatory officer of Tetra, explained how the drug went from having no chance of ever being commercialized to getting revived by the US regulator.
However, now Tetra will be able to resume the trial and begin enrollment of patients “as quickly as possible.” According to the Canadian company, the federal agency approved the restart of the trial after reviewing the files of the trial and guaranteeing the safety standards for participating patients.
Chamberland told INN the company was faced with resetting its trial due to the mycotoxins in its original model.
In response to this conflict, the company developed a synthetic version for its drug. However, Chamberland said the nature of a wide variety of patients is to consume the drug by way of dried flower.
Chamberland said Tetra submitted to the US regulator a month ago almost as an afterthought since the Canadian regulators told the company they were not interested in any drug with mycotoxins. “Our hopes were actually pretty low,” he said.
That changed when the US regulator asked for a meeting, at which the company expected to hear a simple response.
“To our surprise, it was beyond that, they were basically ready to approve it.
“Their biggest concern was not the mycotoxins; they obviously thought we were addressing it adequately for them. The issue was patient safety from a liver toxicity point of view,” he told INN.
The regulator raised questions on the monitoring of suicidal tendencies among its studied patients and patients with liver toxicity issues.
Shares of the company jumped following the announcement. Tetra Bio-Pharma opened at a price of C$0.22. As of market close on Monday’s trading session, the company finished with a share price uptick of 25 percent, up to C$0.25.
The trial, dubbed Plenitude, consists of a four-week double-blind, randomized, placebo-controlled, parallel group design study by the company. There are 78 adult patients taking part in it.
Tetra is moving ahead of the results from its trial by setting in place the potential commercialization of Qixleef through a search for a commercial partner to aid in the distribution and sale of its medicine.
The company is also bullish on the development of its Caumz drug, a cannabinoid medicine for chronic pain using 9.5 percent synthetic tetrahydrocannabinol (THC) and 2.5 percent cannabidiol (CBD).
Tetra is expecting approval of Caumz in the US and Canada by late 2020.
The spotlight for marijuana-based medicines expanded after GW Pharmaceuticals (NASDAQ:GWPH) obtained approval from the FDA for its medicine Epidiolex, a drug designed to treat seizures related to Lennox-Gastaut syndrome and Dravet syndrome in patients aged two years and older.
The landmark approval for the CBD drug marked a shift in potential for the pharmaceutical space based on marijuana assets.
A pharmaceutical approach to cannabis has been promised by a variety of public firms in the hopes the differentiator will offer better results than the more direct grower play in the industry.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.