PharmaCyte Biotech Inc (PMCB)

[Triple9]

CiaB for pancreatic cancer in 2017:

Jan 4, 2017: $PMCB Announces pre-IND meeting with FDA

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®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

http://ir.pharmacytebiotech.com/press-releases/detail/126/pharmacyte-biotech-announces-pre-ind-meeting-date-with-fda

Jan 10, 2017: $PMCB Discusses Upcoming Clinical Trial with Principal Investigator Dr. Manuel Hidalgo

For those who aren't familiar with the clinical trial process and the development of a therapy for pancreatic cancer, why is it important to have an experienced team surrounding PharmaCyte's technology heading into its clinical trial?

Dr. Manuel Hidalgo: “I cannot emphasize enough how important having an experienced team is to conducting any clinical trial, but even more a trial with a new technology like Cell in a Box®. Elements of an experienced team range from proper patient selection to the delivery of the treatment and monitoring safety and efficacy. Each one of these elements, just to name a few, requires careful attention to details, proper documentation and communication. As this is a new technology and is a non-conventional one, these details become even more important. This is like a performance. The sheet music (protocol) is important but the conductor (investigator) and the orchestra (research team) are also critical.”

http://ir.pharmacytebiotech.com/press-releases/detail/126/pharmacyte-biotech-announces-pre-ind-meeting-date-with-fda

Jan 17, 2017: $PMCB has pre-IND meeting with FDA

Jan 30, 2017: $PMCB Retains Facet Life Sciences to Guide Pancreatic Cancer Therapy Development Lifecycle with FDA

The Chief Executive Officer of PharmaCyte explained retention of Facet, “After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

“Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet.”

http://ir.pharmacytebiotech.com/press-releases/detail/130/pharmacyte-biotech-retains-facet-life-sciences-to-guide

Feb 8, 2017: $PMCB Releases Shareholder Call and Complete Q&A Playback Information

http://ir.pharmacytebiotech.com/press-releases/detail/132/pharmacyte-biotech-releases-shareholder-call-and-complete

Feb 13, 2017: $PMCB Moves Closer to Filing IND with Naming of Comparator Arm for Upcoming Clinical Trial and Discusses Pivotal Trial Opportunity

In the company’s upcoming trial, the comparator arm that PharmaCyte’s pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV). The necessary and quick decision was made by Dr. Manuel Hidalgo, the Principal Investigator for the upcoming clinical, Dr. Daniel Von Hoff with Translational Drug Development (TD2), the CRO for PharmaCyte’s clinical trial, and Dr. Matthias Löhr, the Chairman of PharmaCyte’s Medical and Scientific Advisory Board.

http://ir.pharmacytebiotech.com/press-releases/detail/133/pharmacyte-biotech-moves-closer-to-filing-ind-with-naming

Feb 21, 2017: $PMCB Discusses Patient Enrollment and TD2’s Role in Upcoming Clinical Trial

TD2 has been involved in many clinical trials. What are your early impressions of PharmaCyte's pancreatic cancer therapy?

Dr. Stephen Gately: “New and effective therapies for patients with pancreas cancer are clearly needed. We have reviewed PharmaCyte’s prior human clinical data and are encouraged that this approach may provide clinical benefit for patients with pancreas cancer. TD2 is grateful for the opportunity to work with PharmaCyte’s team on this exciting project.”

http://ir.pharmacytebiotech.com/press-releases/detail/134/pharmacyte-biotech-discusses-patient-enrollment-and-td2s

March 17, 2017: $PMCB Biotech CEO Addresses IND Submission Questions

PharmaCyte does not plan to publish a date for the filing of its IND. At the current time, it’s extremely difficult for the company to supply a development timeline that will accurately predict when the IND will be filed. It would be irresponsible of the company to release what, at this point, would be a “hopeful” date for filing the IND. This date could change from day-to-day and week-to-week based upon several unforeseen variables – many of which are beyond PharmaCyte’s control. This means that we cannot give an accurate timeline for filing the IND because we too are awaiting a list of items to be completed by others.

http://ir.pharmacytebiotech.com/press-releases/detail/137/pharmacyte-biotech-ceo-addresses-ind-submission-questions

May 8, 2017: $PMCB Updates IND Submission Process in Interview with Facet Life Sciences

“An IND encompasses many things, dealing with the manufacture and characterization of the product candidate, the clinical study design and nonclinical studies. PharmaCyte’s therapy for pancreas cancer has undergone or been part of several studies, so incorporation of that information into the IND is not ‘rate limiting’ or ‘slowing down the progress towards submitting an IND.’ The clinical study design that PharmaCyte agreed to undertake after meeting with the FDA is currently being drafted. This is also not rate limiting. To conduct the clinical trial, PharmaCyte will need to manufacture, test and release a Master Cell Bank, a Working Cell Bank and the encapsulated live cells. This information is also required to be described and documented in detail in the IND. The manufacture of these items is the rate limiting factor involved in submitting the IND.”

“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”

http://ir.pharmacytebiotech.com/press-releases/detail/144/pharmacyte-biotech-updates-ind-submission-process-in

July 6, 2017: $PMCB Releases Presentation to Oncologists and Interviews from 2017 ASCO Meeting Event

http://ir.pharmacytebiotech.com/press-releases/detail/148/pharmacyte-biotech-releases-presentation-to-oncologists-and

http://pharmacyte.com/Media/