PharmaCyte Biotech, Inc. (OTCQB: PMCB) is a biotechnology company that focuses on developing treatments for cancer and diabetes. Shares of the biotech company are surging 42.57%, during early trading on Tuesday, November 29, 2016. Over the past three months, PharmaCyte Biotech, Inc. has seen average daily volume of 3.8 million shares. However, nearly 14.34 million shares or dollar volume of $1.02 million has already exchanged hands through early trading Tuesday.
PharmaCyte Biotech, Inc. is soaring during trading on Tuesday, after the company was granted a Pre-IND (investigative new drug) FDA meeting for its pancreatic cancer treatment. The company will meet with the FDA and submit a complete information package detailing of the new drug, for review. Here is the full press release detailing of the FDA meeting:
PharmaCyte Biotech, Inc. Press Release:
LAGUNA HILLS, Calif., Nov. 29, 2016 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (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 a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA’s satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, “We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care – the combination therapy of Abraxane® plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.
About PharmaCyte Biotech, Inc.
PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.