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Wednesday, October 04, 2017 1:59:58 PM
May 8, 2017
PharmaCyte Biotech Updates IND Submission Process in Interview with Facet Life Sciences
“Before the IND is filed, the following items must be available for inclusion:
(a) Documentation of preclinical work done on the cells.
(b) Toxicology studies.
(c) Documentation of preclinical work done on the capsules themselves.
(d) A wide array of CMC (Chemistry, Manufacturing and Controls) documentation that verifies that the final biologic product (the encapsulated cells) has been produced under current Good Manufacturing Practices (cGMP)-compliant conditions.
(e) Labeling for the final investigational biologic product.
(f) Previous evidence of human experience with the pancreas cancer therapy (low-dose ifosfamide plus Cell-in-a-Box® encapsulated genetically modified human cells).
(h) The Investigator’s Brochure.
(i) The Informed Consent Form
(j) The Case Report Form”
May 31, 2017
PharmaCyte Biotech to Attend 53rd Annual Meeting of the American Society of Clinical Oncology
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “This year’s annual meeting of ASCO will be our most important as we work towards enrolling the first patient in our planned clinical trial in locally advanced pancreas cancer (LAPC). During this multi-day event, we will be hosting a special meeting of leading clinical oncologists who have expressed interest in participating in our clinical trial.
June 9, 2017
PharmaCyte Biotech Updates Shareholders on ASCO Presentation to Oncologists
Commenting on the meeting, Mr. Waggoner said, “We were pleased to have had this unique opportunity to update the various stakeholders on the progress we have made in several aspects of our planned clinical trial. We are extremely grateful to the oncologists who attended the meeting, as well as the representatives from TD2 and Imaging Endpoints who participated in the meeting. We are particularly grateful to Dr. Matthias Löhr who travelled from Sweden to lead the discussion on the trial design and respond to questions posed by the oncologists.”
LINK to Videos: http://pharmacyte.com/Media/
June 13, 2017
PharmaCyte Biotech to Present Pancreatic Cancer Therapy at 2017 BIO International Convention
“Having won the 2017 Buzz of BIO 'Pipelines of Promise' award, we have been given the opportunity to build upon that by presenting PharmaCyte’s therapy for pancreatic cancer to thousands of industry leaders who will attend this year’s convention.
“We are also being interviewed by Mike Huckman, a former pharmaceuticals reporter for CNBC, to showcase our pancreatic cancer therapy. And we have meetings scheduled with potential strategic partners, biotech companies that have expressed an interest in PharmaCyte and numerous other industry thought leaders who have reached out to us to learn more about PharmaCyte.”
July 10, 2017
PharmaCyte Biotech Appoints Dr. Linda S. Sher as Chief Medical Officer
Dr. Sher is a Professor of Clinical Surgery and Director of Clinical Research in the Division of Hepatobiliary and Pancreatic Surgery and Abdominal Organ Transplantation at the University of Southern California’s (USC) Keck School of Medicine. Dr. Sher is also the Chief of the Division of Clinical Research for the Department of Surgery where she oversees the implementation and conduct of clinical trials for the entire department, averaging between 50 and 70 studies at all times. She is also the Vice Chair of the USC Institutional Review Board.
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