PharmaCyte Biotech Inc (PMCB)

[TPX]

Pharmacyte Biotech Inc (OTCMKTS:PMCB) Targeting To Produce 6-Month Revolutionary Data

Tuesday, 13 Dec 2016

Pharmacyte Biotech Inc (OTCMKTS:PMCB) is one step closer to registering subjects in a crucial clinic study in inoperable pancreatic cancer in advanced stage after the FDA approved its application for a pre-IND meeting. A group of oncologists, clinicians and scientists representing Pharmacyte will enter into discussion with the U.S. regulatory agency so as to progress with an Investigational New Drug application. The filing of this application is the final step before subjects can be registered in a clinical study.

The highlights
Pharmacyte has formulated a team of world-famous oncologists that includes Dr. Manuel Hidalgo, Dr. Matthias Löhr and Dr. Daniel Von Hoff nt to begin a clinical study in the United States and Europe, the FDA’s IND course is vital. After the IND method runs its course, stockholders should be all set for a planned six-month “hard stop” in the clinical study could bring in the way of information to the industry. Judging by the past performance noted in previous clinical trials, the company may be slightly away from what could result into an extremely powerful story for patients with inoperable pancreatic cancer in advanced stage.

The assessment of report at the end of this period could drive Pharmacyte to file for Breakthrough Therapy Designation. A breakthrough therapy is administered alone or in conjunction with other drugs to treat a grave or life threatening condition or disease, and initial clinical evidence implies that the medication may demonstrate substantial improvement compared to existing therapies on clinically significant endpoints.

The FDA speeds up the development and assessment of the drug/therapy that has been stated a breakthrough therapy. Pancreatic cancer therapy designed by Pharmacyte has already been granted the Orphan Drug Designation from the European Medicines Agency and the FDA, so if the company manages to repeat the data from preceding clinical trials, it has a good chance of getting breakthrough therapy designation.

http://www.mmjobserver.com/pharmacyte-biotech-inc-otcmktspmcb-targeting-to-produce-6-month-revolutionary-data/8961/