Tag: OTCMKTS:PMCB

Pharmacyte Biotech Inc (OTCMKTS:PMCB) has released several Q&A articles that provide insight into the submission process of IND (investigational new drug application), and the FDA required tests. Dr. Gerald W. Crabtree, Chief Operating Officer of Pharmacyte, provides the details into the IND submission process and the necessary tests. He brings in more than fifty years of experience in pharmaceutical and biotech companies and in academia. Gerald played a major role in developing drugs and cancer treatments. He also coordinated and monitored several drug candidates’ development and prepared several clinical protocols, monographs, and investigator brochures.

Pharmacyte awaits test results of the pyrogenicity test

What is the pyrogenicity test, and why is it needed?

According to Gerald, FDA intends to know whether the Cell-in-a-Box capsules, which are used in the LAPC treatment, have any fever inducing properties. Pyrogenicity is conducted to collect this data and submit to the US FDA. The treatment for this tumor uses the combination of a biologic, which comprises genetically engineered and live human cells that are encapsulated with the help of unique cellulose-based technology, and cancer prodrug.

Hundreds of empty Cell-in-a-Box Capsules

Pharmacyte needs hundreds of empty Cell-in-a-Box Capsules to conduct the pyrogenicity test. Its partner – Austrianova will produce these Cell-in-a-Box Capsules in large quantity at its production facility in Thailand. Austrianova has filled the syringes with empty Cell-in-a-Box Capsules and congealed those syringes with the same freeze medium which is used for the clinical study. The company shipped the resultant materials to the US for conducting the pyrogenicity test.

The crushed Cell-in-a-Box Capsules and saline are injected into three rabbits. It takes a month to complete the test, get the audited results report, and submit to the US FDA. This is part of the IND package of Pharmacyte.

What goes into submission of IND?

The size and complexity of an IND depend on the development stage of a product. If Pharmacyte files an application requesting permission to conduct phase 1 clinical study, then the product in question is an innovative drug. The IND comprises details about how the drug is manufactured, and the animal and preclinical data provide details about what type of tumor it attacks. It also gives dosage information to cure the tumor and provides details of side effects effectively.

Clinical stage biotechnology firm Pharmacyte Biotech Inc (OTCMKTS:PMCB) announced on Thursday that David A. Judd is the latest executive to join its Medical and Scientific Advisory board.

The company believes that Judd is a great addition to the board, especially due to his extensive experience in cell culture research and development, in which he has over 30 years of experience. Additionally, his experience spans into cell culture for different types of human cells. He has also worked cells that PharmaCyte uses to treat cancer and has extensive knowledge about the growth properties of those cells.

“We feel the appointment of Mr. Judd to our Medical and Scientific Advisory Board comes at a crucial time,” stated PharmaCyte CEO Kenneth L. Waggoner.

Judd’s appointment comes amid the progress with Austrianova

PharmaCyte Biotech is currently working with Austrianova on the final manufacturing stages in the production of encapsulated cells required for non-metastatic, pancreatic cancer clinical trials. The company announced that Waggoner spent the better part of June in Bangkok, Thailand to monitor the progress in the development of the encapsulated cells to be used in the clinical trial.

PharmaCyte Biotech also posted on its website some videos documenting the production activities from Austrianova manufacturing facility. The content of the videos also includes a walkthrough of the GMP-manufacturing plant.

Mr. Judd believes that PharmaCyte’s platform can change the processes of treating solid tumors so that there is little to none of n the side-effects of chemotherapy. He has also been working closely with the Austrianova team to make sure that the cells they produce grow as anticipated before and after encapsulation.

Judd was also present at the Bangkok-based GMP manufacturing facility as one of the advisors courtesy of his extensive knowledge in the biotechnology. Mr. Waggoner noted that this company selected Mr. Judd to join the Medical and Scientific Advisory board due to the contributions that he has already made to PharmaCyte’s cancer research program. The CEO also believes that Judd will not only be a valuable asset for the development of cellular treatments for cancer but also for diabetes.

Mr. David Judd, a consultant cellular biologist, and Chief Executive Officer of Pharmacyte Biotech Inc (OTCMKTS:PMCB), Kenneth L. Waggoner will visit the GMP production facility of Austrianova in Bangkok, Thailand. They will oversee the production of a clinical trial material to treat non-metastatic and locally advanced inoperable pancreatic cancer. Judd and Wagonner will witness the culturing of genetically changed HEK-293 cells before and after the encapsulation process.

Expertise of Judd

Judd has experience in developing cell culture media for several cell lines and primary cells. He has knowledge in HEK-293 cells growth. Judd’s credits include development of cell assays, manufacturing processes, downstream recovery strategies, cell culture processes, and biochemical analysis.

The company has requested the on-site presence of Judd to help correct any problems in the manufacturing process because the most recent two staggered processes are already completed.

Waggoner said they are on track after incorporating changes in the manufacturing process and proceed with CypCaps GMP production. He felt that their presence is necessary at the site to oversee the entire process during production of the clinical material for non-metastatic and locally advanced inoperable pancreatic cancer. It ensures they are on the path and within the time limit to submit IND (investigational new drug) application. Therefore, the presence of Judd is an absolute necessity because the two manufacturing processes are conducted in a staggered manner.

Interview in Thailand

There is a possibility to interview Austrianova’s Dr. Brian Salmons, Prof. Dr. Walter H. Günzburg, Judd, and Waggoner on the progress of production of clinical material for trial while in Bangkok. The interviewers may ask details of the factors involved in the production process, and clinical trial product testing in submitting IND.

Pharmacyte may post the interviews, images, and videos on social media while CEO and Judd are on at the site. Interested parties in the content can visit the social media platforms of the company.

Cannabinoid therapy for cancer

The University of Northern Colorado, the partner of Pharmacyte, bioengineered the human cell line for activating cannabinoid pro drug. The main aim is to develop a cannabinoid therapy to cure brain cancer. In the next step, it will test the transfected cells efficiency in altering the cannabinoid drugs into the active cancer treatment form.

Pharmacyte Biotech Inc (OTCMKTS:PMCB) currently working on its Investigational New Drug application and has sought the expertise of cGMP Validation to ensure that they submit a flawless masterpiece to the U.S Food and Drug Administration (FDA) for vetting.

The Cell-in-a-Box^®,

The IND is for its proprietary Cell-in-a-Box^®, a futuristic technology for live-cell encapsulation targeted for Cancer and Diabetes patients. The IND submission to the FDA is important for the company as it is through the same that the licensing board will determine whether to approve or decline the drug’s use.

With the guiding of cGMP Validation, the company will be in a better position to submit a a sound application that will sure pass the vetting process. cGMP Validation has been in business for over two decades now and is conversant with the process. The company has a host of satisfied clientele across several continents. The company delights a skilled management with intense pharmaceutical experience led by its President and Chief Executive Officer, Jesse Gillikin.

cGMP Validation impressive portfolio

cGMP Validation serves a variety of clients ranging from the pharmaceutical, biotechnology and medical diagnostic spheres among many others. Its role is to ensure that companies meet FDA’s cGMP requirements while submitting their INDs. cGMP Validation steps in to validate companies’ manufacturing equipment, ensure that the manufacturing process is compliant, confirm that the company adheres to cleaning standards and computer validation. The vast experience the company has garnered over the years puts it in a position to draft and even enforce validation doctrines.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner speaking about the pending processes before the innovative drug is available to patients said that, “Our checklist of items to be completed has been whittled down to just a few remaining items, and cGMP Validation provides us with the confidence moving forward to get across the finish line.”

Due to the urgency of the process, the company has since suspended its over scheduled shareholder meeting to Q1 2019 in order to complete the IND preparation and submission.