Pharmacyte Nears Approval Of Lead Product Utilizing Live-Cell Encapsulation

Pharmacyte Nears Approval Of Lead Product Utilizing Live-Cell Encapsulation

In mid-January 2019, Pharmacyte Biotech Inc. (OTCMKTS:PMCB) announced the successful use of live-cell encapsulation technology. The technology encapsulates cancer cells such that they do not spread. Austrianova, the company’s partner, successfully encapsulated cells using the technology. Austrianova used the technology for the clinical trial of its lead product in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

Cell-in-a-Box® technology could be available sooner than expected

Dubbed Cell-in-a-Box®, the technology encapsulates cancer cells in LAPC patients such that they grow inside the capsule. The entrapment of the cells ensure that they do not spread to other parts of the patients’ bodies. This is a novel procedure that, if approved by the U.S. FDA, will be the first of its kind on the market.

According to a statement, the company is closing in on the possibility of the FDA approval of the Cell-in-a-Box® technology. The company could be looking at mere months to open an Investigational New Drug (IND) application. This implies that the treatment process underlined by Cell-in-a-Box® technology could be available to patients sooner than expected. According to PharmaCyte, the recent successful procedure by Austrianova is enough evidence that the technology has only a few hurdles to achieve this major milestone.

Pharmacyte anticipating clinical trials

Notably, the company outlined four steps as remaining hurdles. First, PharmaCyte will have to prove to the FDA that the live cells can fill the Cell-in-a-Box® capsules fully. Secondly, the company will need to demonstrate that they can place the fully-filled capsules inside syringes frozen. The third step involves the FDA testing the capsules to ascertain their feasibility as well as efficacy. Lastly, Pharmacyte will need to write reports and submissions of the IND application to the FDA.

As per the company, the primary objective of submissions to the FDA will be to garner permission to open clinical trials. Notably, the firm would want to trial the technology as well as the dosage of ifosfamide that can safely treat LAPC.

If the FDA approves the commencement of the clinical trials, it will become the first ever for Pharmacyte. The treatment addresses an unmet medical need and there is a possibility for an accelerated approval after clinical trials are completed.