Tetra Bio Pharma Inc (OTCMKTS:TBPMF) completed a Type B meeting with the USFDA for its new drug HCC011. The company received an orphan designation for this product to cure hepatocellular carcinoma.
Receives guidance from the FDA on safety and efficiency needs
Tetra received guidance from the USFDA for conducting clinical pharmacology and non-clinical safety on humans and safety trials, which are prerequisites for the marketing approval of HCC011 for the treatment of cancer. The company also received the FDA’s nod for its proposed non-clinical safety study for NDA (new drug application) and clinical development program.
Food effect trial not necessary for HCC011
The food effect study is not a necessity for HCC011because absorption takes place in the lungs. Therefore, it will not affect the metabolism in the liver.
Several pharmaceutical companies obtained the FDA’s nod for the expedited launch of anticancer drugs based on the single-arm study. Tetra used this path for guidance from the USFDA for developing HCC011 to act as an addition to sorafenib. The administration of these two drugs together will provide a better outcome for the patients.
Tetra need to demonstrate HCC011 effect on tumors
According to the FDA, Tetra is obligated to demonstrate the effect of HCC011 on progression of tumor as monotherapy before targeting to develop it as an adjunct to the drug – sorafenib. Tetra also needs to show the progression-free survival effect in patients using HCC011 for expedited approval. CRO and CEO of Tetra, Guy Chamberland, said the company obtained the feedback of the FDA from its Friday meeting, and its R&D team will proceed with the development.
Establishes TALLC Corporation Inc
Tetra, along with Altus Formulation Inc, established a new company called TALLC Corporation Inc. The new company, based in Quebec, will focus on developing an innovative endocannabinoid CB2 receptor activator – TA-A001, which possess anti-inflammatory analgesic properties.
TALLC will receive funding from Tetra and Altus. The company will develop TA-A001 as an intravenous analgesic. The new drug will help TALLC to clinch a lion share of the surgical pain market, which is around $4 billion. TA-A001 will also be developed as a micellar eye drop to treat dry eye disease and ocular pain.