Tetra Bio-Pharma Secures Orphan Drug Designation from FDA

Shares of a Canadian small market cap medical cannabis research firm jumped after it obtained a critical notice from the US Food and Drug Administration (FDA).

Tetra Bio-Pharma (TSXV:TBP,OTCQB:TBPMF) confirmed on Wednesday (December 4) that its delta-9-tetrahydrocannabinol (THC) treatment of hepatocellular carcinoma received orphan drug designation from the federal regulator.

The FDA offers this denomination for drugs designed to treat rare diseases; it serves as an incentive for companies in the pharmaceutical development cycle.

The company opened Wednesday’s trading session at a price of C$0.52 per share, representing a nearly 10 percent jump from its previous closing price. As of 12:10 p.m. EST, Tetra Bio-Pharma traded up 13.68 percent to a price of C$0.54.

Guy Chamberland, CEO and chief regulatory officer of the company, said the approval will cause the company to now prepare a modified formulation of its drug for hepatocellular carcinoma as part of a clinical trial in Q1 2020.

Hepatocellular carcinoma is a common type of liver cancer; according to the Mayo Clinic, it most commonly affects patients with chronic liver diseases.

“This second (orphan drug designation) for cannabinoids demonstrates our innovation and successful drug development program that will soon include hepatocellular carcinoma,” Chamberland said.

The executive added that the company will be able to incorporate the drug as a cancer therapy with supposedly no extra cost to its investors.

“The Caumz-kit technology already exists, so we will maximize our investment in the development of inhaled cannabinoid drugs to bring another drug to the market,” Chamberland said.

Investors of Tetra Bio-Pharma have seen an upswing in the company thanks to recent critical developments to its medical cannabis drug pipeline.

In November, the company restarted its trial for PPP001 after obtaining approval from the FDA. This drug is being investigated for patients facing pain management issues related to cancer.

Chamberland told INN the company was surprised to find out about the ruling from the health agency in the US.

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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.