PharmaCyte to submit IND application to FDA for clinical trial in LAPC
Category: #health  By Saipriya Iyer  Date: 2020-08-05
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PharmaCyte to submit IND application to FDA for clinical trial in LAPC

PharmaCyte Biotech, a clinical-stage biotechnology company, is reportedly set to submit an IND (Investigational New Drug) application to the U.S. FDA. The IND application is related to the Phase 2b clinical trial among patients with LAPC (locally advanced, inoperable pancreatic cancer). LAPC has become the 3rd leading cause of death related to cancer in the U.S.

Pancreatic cancer is difficult to treat, with only a 9% 5-year survival rate. Therefore, the recent submission of DMF (Drug Master File) by Austrianova, a partner of PharmaCyte, to the FDA symbolizes the near completion of IND package submitted to the agency in August.

According to Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte, the company has reached a milestone, with its partner, Austrianova, submitting a DMF to the U.S. FDA to produce CypCaps™, a Cell-in-a-Box® encapsulated cell product.

Dr. Brian Salmons, Austrianova’s CEO & President, also has cited that the recent DMF provides comprehensive, detailed and confidential information that covers the Cell-in-a-Box® encapsulated cell solutions’ production, including CypCaps™ of PharmaCyte. The DMF provides detailed information on the production facilities of Austrianova in Thailand where CypCaps™ is being manufactured under GMP.

For the record, DMF is a prerequisite to gaining approval & commercialization of the drugs. It also ensures the confidentiality of the proprietary information that is related to the API (Active Pharmaceutical Ingredient). PharmaCyte had previously revealed a list of tasks to be completed prior to submitting the IND to the FDA, most of which were performed by the consultants of PharmaCyte.

Mr. Waggoner further commented on the IND status, stating that the company had completed the Study Reports, Pharmacy Manual, Nonclinical Written & Tabulated Summaries, Clinical Overview, Nonclinical Overview, Introduction Summary, General Investigation Plan, Environmental Analysis, Investigator’s Brochure, Trial Protocol, and other information related to the treatment of LAPC patients in the past few months. He further stated that the company expects the completion of the Informed Consent and CMO hiring over the next week, following which it will file the IND application.

Source credit:

https://www.globenewswire.com/news-release/2020/08/03/2071744/0/en/PharmaCyte-Biotech-Ready-to-Submit-Investigational-New-Drug-Application-to-FDA-for-Clinical-Trial-in-Pancreatic-Cancer.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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