LOOKS LIKE cGMP FOR PHARMACYTE BIOTECH IS COMING SOON.....
PharmaCyte Contractor Chamow & Associates to Visit Cell-in-a-Box® Encapsulation Facility in Bangkok, Thailand
SILVER SPRING, Md., Dec. 04, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that representatives from Chamow & Associates, the San Francisco Bay Area firm contracted to assist PharmaCyte in preparing the Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug Application (IND) that will be submitted to the drug regulatory authorities before commencement of PharmaCyte’s pancreatic cancer clinical trial, will visit the Austrianova Cell-in-a-Box® encapsulation facility next week located in Bangkok, Thailand.
The purpose of the visit is to determine whether the facility meets current Good Manufacturing Practices (cGMP) standards and to develop the necessary CMC information that must be included in the IND PharmaCyte will be submitting to the U.S. Food & Drug Administration (FDA). The visit will also identify any additional work that must be accomplished at the facility before submitting the IND. The IND is the seminal document that must be acceptable to the FDA and to drug regulatory authorities in other countries where the clinical trial will be conducted. Its acceptance by such authorities is the final step before PharmaCyte’s clinical trial can begin.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, explained, “The visit by representatives of Chamow & Associates is extremely important for ensuring that the CMC section of the IND for our trial in pancreatic cancer is both complete and correct. By virtue of this visit and contributions from Chamow & Associates to our preparation of the IND, we are confident that this critical section of the IND will be acceptable to the FDA and other drug regulatory authorities.”
The Bangkok-based live-cell encapsulation facility will produce capsules with genetically modified live cells using the Cell-in-a-Box® technology that will be used as a new consolidation therapy for patients with inoperable, non-metastatic pancreatic cancer. The new consolidation therapy forms the basis for PharmaCyte’s upcoming clinical trial involving patients with pancreatic cancer whose tumors no longer respond after 4-6 months of treatment with gemcitabine plus Abraxane®, currently the “gold standard” of treatment for advanced inoperable pancreatic cancer.
One of the therapies frequently used for these patients consists of the combination of the anticancer drug capecitabine and x-radiation, a somewhat ineffective and toxic treatment for pancreatic cancer patients. PharmaCyte’s pancreatic cancer treatment will be compared to this combination therapy as a new consolidation therapy after gemcitabine and Abraxane® in patients whose inoperable tumors no longer respond to the gold standard. Progression-free survival and overall survival will be determined for each of the therapies being compared. In addition, the extent to which the comparative therapies can reduce inoperable tumors to become operable will be determined. The safety of the two treatments will be compared as will their effectiveness in ameliorating the pain that accompanies pancreatic cancer. The overall quality of life of the patients undergoing therapy will also be carefully studied.
looks like crow pie for 2
bull
