Delay after delay has plagued PharmaCyte Biotech Inc (OTCMKTS:PMCB). First, the company's clinical trial for pancreatic cancer was to have already been underway, but it isn't. Matter of fact, management has no clue when it will start as the entire trial is now being redesigned. Second, the Thailand manufacturing facility was to go into production. Again, that won't be happening anytime soon as the facility has a number of items that need to be implemented to bring the facility up to code. Shareholders have rightfully grown impatient.We were told last year that PharmaCyte’s clinical trial in pancreatic cancer would get underway with Translational Drug Development (TD2) coordinating the trial globally and conducting it in the United States. Clinical Network Services (CNS) was to conduct the trial in Europe and Australia in alliance with TD2. PMCB was also going to be talking to other cancer centers concerning patients that no longer benefit from receiving the “gold standard” treatment – the combination of gemcitabine and Abraxane.After the pancreatic cancer clinical trial had been in process for approximately six months, there would be an evaluation of PharmaCyte’s pancreatic cancer treatment on the patients enrolled in the trial with the interim results being reported. Additionally, preclinical studies would determine if PharmaCyte’s pancreatic cancer treatment can slow down the production and accumulation of malignant ascites fluid. If successful, plans to conduct a clinical trial in ascites would be undertaken by PharmaCyte with the goal of having TD2 begin the clinical trial by year end or early 2017. Now the company is saying:
“With invaluable input from three of the world’s leading authorities in pancreatic cancer, the trial was completely redesigned to what it is today. We continue to improve the design with the hope that it will result in the best possible outcome for pancreatic cancer patients and that PharmaCyte’s treatment will become a recognized treatment for a significant segment of those with pancreatic cancer. In the newly designed trial, PharmaCyte’s pancreatic cancer treatment will be compared against the best available therapy (the combination of chemotherapy drug capecitabine + radiation) in patients whose pancreatic cancer no longer responds to either the Abraxane® + gemcitabine combination or a 4-drug combination known as FOLFIRINOX. Adding FOLFIRINOX to the inclusion criteria is a new element and expands the potential patient population that will be available to participate in the trial. These therapies are by far the most widely used around the world to treat advanced, inoperable pancreatic cancer. Patients in our trial will have tumors that are locally advanced (they have not spread to different organs in the body), but nevertheless are inoperable. Instead of conducting the trial in just Australia, as was proposed in the original trial design, we plan to conduct the trial in the United States with study sites in Europe and Australia."
We were also told that the Bangkok, Thailand manufacturing facility was going into production. The facility was expected to receive a factory license from the Thai government and allow the facility to produce the encapsulated cells for PharmaCyte to use in its clinical trial. Now we're being told:
“Evidence of the cGMP compliance of the encapsulation facility must be presented to drug regulatory authorities as part of the Chemistry, Manufacturing and Controls (CMC) section of the IND. It must be deemed satisfactory by the FDA before the clinical trial can begin. The cGMP facility information makes up the bulk of the CMC information package, which, in turn, makes up the largest and arguably the most important part of the IND. PharmaCyte is very fortunate to have retained Chamow, an outstanding biopharmaceutical consulting firm, that specializes in the inspection of facilities for cGMP compliance and in the preparation of the CMC section of INDs. Chamow is working in concert with TD2 to prepare the CMC section of our IND for the facility in Thailand.”
We did have enthusiasm for PMCB at the beginning of the year when CEO Ken Waggoner outlined his goals for 2016. It was an overly optimistic press release and the company is no where close to achieving its goals. It's still a long ways off before investors can get excited about PMCB. CEO Ken Waggoner needs to deliver or he needs to be shown the door. So far, the shorts have been proven correct in their analysis of the company. Management here is to blame and that has hurt long-term shareholders who believe in the company's potential. Our message is loud and clear: CEO Ken Waggoner needs to deliver and deliver fast. Investor's patience is wearing thin. We will be updating Insider Financial as soon as we know more. For continuing coverage on PMCB and our other hot stock picks, sign up to Insider Financial today and get our next hot stock pick!Disclosure: We have no position in PMCB and have not been compensated for this article.
Discover Hidden Gems
Don't miss the next big opportunity. Subscribe for timely alerts on potential market movers.
