Pharmacyte Biotech Inc (OTCMKTS:PMCB) is successfully making progress with its enrollments process in a pivotal clinic trial targeting advanced, inoperable pancreatic cancer. It started with the enrollment after the FDA approved its pre-IND request meeting. A host of oncologists, clinicians and renowned scientists will discuss with the U.S. regulatory agency on the related study and gain valuable insight on Investigational New Drug application. This is a step that comes after the enrollment process step in a clinical study.
What is the progress?
With Pharmacyte Biotech and a team of famous oncologists all set to introduce a clinical trial in the United States as well as Europe, the FDA’s IND step is vital to accomplishing the goal. After the IND procedure runs its course, stockholders need to be prepared for a 6-month hard stop in the reported clinical trial could lead in the way of report to the industry. Believing the past performance recorded in previous Pharmacyte clinical trials, the company is quite close to making a powerful story for people with severe, inoperable pancreatic cancer.
The company’s pancreatic cancer therapy has been awarded the Orphan Drug Designation, so if it can repeat the strong performance of earlier clinical trials, there is a strong chance that it could successfully get the breakthrough therapy status from the FDA.
There are two segments specifically that could drive to this designation, and they are the quality of life and how well Pharmacyte’s treatment can shrink inoperable tumors for making them operable. In earlier studies, the firm’s treatment did enhance the quality of life and presented the capacity to shrink a pancreatic tumor.
Pharmacyte has acknowledged that there is presently an unmet medical requirement in a segment of locally advanced pancreatic cancer. There are patients that no longer get any benefit from taking of the combination of Abraxane® and gemcitabine after almost 4-6 months of treatment.