On February 4, 2019 PharmaCyte Biotech (OTCQB: PMCB) is now closer than ever to reaching what would be a monumental milestone in the company’s history (Press release, PharmaCyte Biotech, FEB 4, 2019, View Source [SID1234533033]). Years of patience from PharmaCyte’s shareholders has now likely been whittled down to what should now be just months, and with the condensed timeline, the company is reported that this is approved Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for its development of a treatment for patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
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PharmaCyte is a California-based biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box. When the company recently announced that it had successfully encapsulated the live cells used in its therapy for patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC), and that those cells are now growing and dividing inside the Cell-in-a-Box capsules, the news seemed to suggest that all of the pieces necessary to complete and submit the long overdue IND application to the FDA are falling into place for the company’s upcoming clinical trial in the treatment of LAPC.
After enduring what has been a lengthy and time-consuming checklist of FDA-required tests, reports, documents and meetings, PharmaCyte’s shareholders should take comfort in knowing that the list of items they’re waiting on has now been trimmed to (1) the encapsulated live cells fully filling the Cell-in-a-Box capsules, (2) the fully-filled capsules being placed into syringes and frozen, (3) FDA-required testing of the capsules, and finally (4) the writing of the reports and submission of the IND application to the FDA.
Currently, PharmaCyte’s submission of an IND application is what has its shareholder’s attention, but it is what an FDA approval of that application would mean for PharmaCyte that will soon garner the most attention. Once the FDA has approved the company’s IND application for Cell-in-a-Box + low doses of ifosfamide to treat LAPC, the FDA’s approval will officially permit PharmaCyte to open clinical activities throughout the country.
After speaking with PharmaCyte’s Chief Operating Officer, Gerald W. Crabtree, we learned that an open IND is key to PharmaCyte realizing a number of benefits that include:
PharmaCyte can begin the formal arrangements required to conduct its clinical trial in LAPC.
PharmaCyte can begin working towards the major milestone of enrolling the first patient in its clinical trial.
PharmaCyte can publish that the technology behind its LAPC treatment has passed the incredibly difficult FDA screening process and met all of the FDA’s regulatory requirements.
An open IND gives PharmaCyte credibility in terms of delivering on an FDA clinical trial and persevering through a number of setbacks and delays.
Having an open IND with the FDA will offer global exposure of PharmaCyte’s Cell-in-a-Box technology.
PharmaCyte could begin to credibly seek a joint venture/partner in developing its therapy for LAPC if it should choose to go that route.
And because the therapy is the same, it would also allow PharmaCyte to credibly pitch the Cell-in-a-Box technology to joint venture/partners to develop its therapy for malignant ascites fluid.
PharmaCyte could also credibly pitch the Cell-in-a-Box technology to joint venture/partners to develop its therapy to treat cancer using the constituents of the Cannabis plant (cannabinoids).
An open IND also signals that many of the major hurdles PharmaCyte faced to get the FDA to approve the initiation of a clinical trial using its unique encapsulation material will not have to be replicated again—meaning that the FDA’s list of extensive requirements related to the capsules that contain live cells for the treatment of diseases will have been met—paving the way for the development of treatments for diabetes and a host of solid tumors.
The upcoming trial will be PharmaCyte’s first-ever clinical trial, and the company’s novel and complex therapy will address what world-renowned oncologist, Dr. Manuel Hidalgo, the trial’s Principal Investigator, says is a therapy to treat "an unmet medical need where there is no effective therapy after the first-line therapy no longer provides any further benefit to a patient."
Should PharmaCyte’s IND submission receive approval from the FDA, the clinical trial may proceed 30 calendar days from the submission date of the IND. And the good news for investors is as Dr. Hidalgo says, "If the results are very positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA."