Pharmacyte Biotech Inc (OTCMKTS:PMCB) is progressing with patients enrollment process in a pivotal clinic study in advanced, inoperable pancreatic cancer after the U.S. FDA approved its request for a pre-IND meeting. A host of clinicians, scientists and oncologists that represent company will now discuss with the U.S. regulatory unit to get valuable insight that will help them in submitting an IND application, the final measure before patients can be registered in a clinical study.
The highlights
With Pharmacyte Biotech and a team of renowned oncologists that comprises Dr. Daniel Von Hoff from TD2, Dr. Manuel Hidalgo and Dr. Matthias Löhr to commence a clinical study in the U.S. and Europe, and to get there, the FDA’s IND process is crucial. After the IND procedure runs its course, investors should be prepared for a planned six-month hard stop in the clinical study could bring data to the industry. If previous performance in earlier clinical studies is any indication, Pharmacyte is too close to what could be a powerful story for patients suffering with advanced pancreatic cancer.
The data review could very well lead to company’s therapy being provided the breakthrough therapy status by the FDA. It should be noted that a breakthrough therapy is a therapy/drug that intended alone or in conjunction with one or more other medication to cure a life threatening or serious condition or disease.
Preliminary clinical data suggests that the medication may show considerable improvement over existing treatments on one or more clinically notable endpoints, such as noteworthy treatment effects seen early in clinical advancement. According to the FDA, if a therapy/ drug is stated as breakthrough therapy, the regulatory body FDA will speed up the advancement and review of the therapy/drug.
Pharmacyte’s pancreatic cancer treatment has already obtained the Orphan Drug status from both the European Medicines Agency and FDA, so if the firm can repeat the data from previous clinical studies, there is a good chance that company could get the breakthrough therapy status from the FDA as well.
