“I am excited about this new approach that has the potential to change the way solid tumors are treated far beyond tumors in the pancreas.”
NEW YORK, NY – With PharmaCyte Biotech, Inc.’s (OTCQB: PMCB) naming of Medpace, Inc., a global full-service clinical contract research organization (CRO) to conduct its clinical trial in locally advanced, inoperable pancreatic cancer (LAPC), and with the recent news that the live cells necessary for that clinical trial have been encapsulated and are growing, we decided to reach out to world-renowned clinician and oncologist, Dr. Manuel Hidalgo, to discuss his role as the Principal Investigator of PharmaCyte’s upcoming clinical trial, the company’s technology, the trial design and more.
Dr. Hidalgo is a Professor of Medicine at the Harvard Medical School. He is also the Chief of the Division of Hematology Oncology and Director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center (BIDMC). Dr. Hidalgo is also Deputy Associate Director for Clinical Sciences at the Dana Farber Harvard Cancer Center.
In his role at the BIDMC, Dr. Hidalgo oversees all BIDMC’s clinical cancer programs. Dr. Hidalgo’s groundbreaking work in experimental cancer therapy has led to key advances in the treatment of pancreatic cancer.
The BIDMC’s Cancer Center, with 160 faculty members and more than $70 million in annual research support, is also home to the Cancer Clinical Trials Office, where hundreds of clinical trials provide patients with access to promising new therapies.
Dr. Hidalgo is unquestionably a leader in oncology worldwide, and PharmaCyte Biotech is extremely fortunate to land Dr. Hidalgo as the Principal Investigator for what could be its landmark clinical trial in pancreatic cancer.
We understand that you were intimately involved in the trial design of PharmaCyte’s upcoming clinical trail. After all of the planning and discussions with other clinicians, oncologists and hospitals involved in treating pancreatic cancer patients, what are your impressions of PharmaCyte’s final trial design?
Dr. Manuel Hidalgo: “I think we came out with a very reasonable design that is geared towards patients that are more likely to benefit from the strategy we’ve developed. Within a relatively short period of time, considering the time it would take to conduct a marketing approval trial, the design we’ve developed should provide clear information about the overall value of PharmaCyte’s unique way to treat pancreatic cancer.
“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.”
What is your opinion of PharmaCyte’s therapy for pancreatic cancer (Cell-in-a-Box® + low doses of ifosfamide)?
Dr. Manuel Hidalgo: “The data from the two earlier trials is very interesting and showed great promise many years ago when compared to the standard of care at the time – gemcitabine alone. Mechanistically the therapy makes a lot of sense. Patients with locally advanced, inoperable pancreatic cancer have a grim prognosis, and PharmaCyte’s therapy is worth exploring in this setting.
“I am excited about this new approach that has the potential to change the way solid tumors are treated far beyond tumors in the pancreas.”
What interested you in accepting the extremely important role of Principal Investigator in such an important clinical trial for those patients who need an option beyond Abraxane® + gemcitabine or FOLFIRINOX?
Dr. Manuel Hidalgo: “As investigators we are always interested in and excited about new approaches to treating pancreatic cancer—the third most deadly cancer and soon to become the second most deadly. With the strong rationale and the preliminary data from the two earlier trials, PharmaCyte’s therapy has the potential to make a significant difference.
“When we try a new treatment we really hope it will be safe and effective for patients. I became attracted to PharmaCyte’s study because I think it has such potential.”
Given your experience with numerous clinical trials, what were you specifically looking for during the CRO selection process that would complement your work as the Principal Investigator of PharmaCyte’s clinical trial in LAPC?
Dr. Manuel Hidalgo: “A CRO is a critical component in conducting a successful clinical trial, and you really need an excellent one with broad experience in the disease being studied – in this case pancreatic cancer. The most important piece, of course, is to be fully compliant with the regulatory requirements in terms of approvals, reporting and related issues.
“PharmaCyte’s therapy is novel and complex and is addressing an unmet medical need where there is no effective therapy after the first-line therapy no longer provides any further benefit to a patient. So, it’s also critical that the CRO has considerable experience with trials involving pancreatic cancer and the patient population we are targeting and has team members who are experienced with the complexities involved with PharmaCyte’s therapy.
“The role of the CRO monitors is also crucial as the quality of the data largely depends on how well the patients enrolled in the trial are monitored. Finally, I like a CRO to be fully integrated with the sponsor and the investigators and not try to function as an independent entity.”
During the selection process, what was it specifically about Medpace that made you comfortable that they were the right CRO for this clinical trial?
Dr. Manuel Hidalgo: “Selecting the right CRO is essential to the success of a clinical trial. In addition to what I said in response to your last question, the CRO must have the demonstrated capability and track record to make sure that the study is 100% regulatory compliant and that the data and study report are perfect in every respect.
“After we met with the Medpace team and went over, in detail, their experience, proposed plan and operational model, I felt very comfortable that their team has the required knowledge and experience and that they would be a good partner with the sponsor and investigators to get the study conducted in the highest regulatory compliance and data quality possible.”
For those unfamiliar with the relationship, how do the Principal Investigator and the CRO interact during a clinical trial?
Dr. Manuel Hidalgo: “The interaction is frequent and at multiple levels. The CRO team visits the sites periodically to monitor patients and for record keeping, and I like to spend a few minutes with them in these visits to review their findings and any plan for corrections if needed.
“As this is a multiple site trial, it is also important to hold frequent conference calls with all the sites to analyze the status of the study, enrollment rate, safety issues and any other issues or questions related to the trial. The CRO is usually in charge of that task and, as Principal Investigator, I envision working closely with them to run these meetings.”
About PharmaCyte Biotech
PharmaCyte Biotech is a biotechnology company developing cellular 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. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. 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 flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating 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 cell lines being studied are human liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they are designed to function as a “bio-artificial pancreas” for purposes of insulin production.
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