Tetra Bio-Pharma (TSXV:TBP,OTCQB:TBPMF) has stepped closer to receiving fast track designation from the US Food and Drug Administration (FDA) for its drug-device combination, which aims to treat patients with incurable malignant cancer.
Monday’s (February 3) announcement follows a meeting the company held with the federal regulator to discuss the eligibility of the cannabinoid-based treatment, called CAUMZ, for the expedited review and approval path, and to provide information on the studies that will bring the product to market.
The share price for the firm rose 3.9 percent from its closing price last week and was sitting at C$0.53 as of 3:16 p.m. EST on Monday.
The drug aims to treat cancer cachexia, a syndrome that causes weight loss, anorexia and anemia in patients with cancer. It has a high morbidity rate and doesn’t respond well to treatment, as per the FDA.
Tetra said the FDA has never approved a product that specifically targets the disorder, making it eligible for fast track designation since it addresses a currently unmet medical need.
Since the drug meets the fast track designation requirements, Tetra said it’s now able to file for the designation request, which will then be decided by the regulator within 60 days.
Drugs that receive the designation have an average review timeline of six months compared to the usual 10 months.
Along with getting the green light to apply for the fast track pathway, the FDA has also cleared Tetra to move ahead with the development of CAUMZ through the accelerated approval program.
The FDA suggested that Tetra use a patient-reported outcome instrument that demonstrates the efficacy of the drug and its benefits.
The accelerated approval program is meant for drugs that use a “surrogate endpoint” that may or may not correlate with a real clinical endpoint because the benefits are measured over a long period of time.
CAUMZ’s development will also benefit from the 505(b)(2) new drug application pathway, the company said, which prevents it from having to redo studies it has already completed and allows it to use data that wasn’t developed by Tetra.
In its review of the new drug, the FDA told Tetra that it needs to look at the interaction between the two cannabinoids, tetrahydrocannabinol and cannabidiol, used in the drug.
“Based on the FDA decisions and guidance, Tetra confirms that CAUMZ will be able to benefit from three regulatory decisions-programs: 505(b)(2) which will lower overall costs, Fast Track designation, and Accelerated Approval which may reduce the time to market,” said Tetra CEO Guy Chamberland.
Last month, the company told investors it was planning to launch its over-the-counter TERPACAN brand of hemorrhoid and back and muscle pain treatments in Canadian pharmacies by mid-2020.
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Securities Disclosure: I, Danielle Edwards, hold no direct investment interest in any company mentioned in this article.