$PMCB to Engage Principal Investigator for Clinical Trial

PharmaCyte’s Chief Operating Officer, Dr Gerald W. Crabtree, commented, “It is crucial that the person selected for this important position be a recognized expert in the treatment of pancreatic cancer and someone who has had experience in multi-site clinical trials for this devastating disease. It is also an advantage if the person selected is familiar with the oncologists who will lead the efforts at the specific study sites. Therefore, it is imperative that PharmaCyte appoint the best available pancreatic cancer authority possible to the post of Principal Investigator to oversee the entire clinical trial.”

PharmaCyte plans to commence a Phase 2b clinical trial in the United States, with study sites in Europe, to meet a critical unmet medical need for patients who no longer benefit from the combination chemotherapies of Abraxane^® + gemcitabine or FOLFIRINOX after 4-6 months of treatment and whose tumors are inoperable and non-metastatic. Currently, chemotherapy + radiation is used for such patients, but this treatment is only marginally effective and carries with it significant side effects. The goal of the trial is to show that PharmaCyte’s pancreatic cancer therapy can serve as a consolidation therapy that is better than the currently used therapy by exhibiting increased antitumor effectiveness and reduced side effects.

The Principal Investigator is a recognized expert in the area of oncology addressed in the clinical trial. This person serves as the general supervisor for the entire trial and acts as a mentor for the site investigators, protecting the rights, safety and welfare of the patients. The Principal Investigator also ensures that the trial is conducted at all study sites in compliance with the clinical trial protocol, procedures and regulations. In addition, the Principal Investigator plays a major role in developing the final study report of the results of the trial.

There is also an individual “site investigator” at each study site. That is usually the oncologist on site responsible for how the trial is conducted at that site. If a trial is conducted by a team of oncologists at a trial site, the site investigator is the responsible leader of the team that administers the treatments described in the clinical trial protocol and conducts treatment-related tests, protecting the rights, safety and welfare of the patients under the site investigator’s care. When tasks are delegated by a site investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated.

About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing and preparing to commercialize treatments 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 treatments for several types of cancer and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, a chemotherapy drug which needs to be activated in the body (ifosfamide) is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the chemotherapy drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.