PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

I am not concerned. These are the things that need to be accomplish before trials can begin...

"In the coming weeks and months, a number of major “milestone” tasks will take place that will enable PharmaCyte Biotech’s first clinical trial to commence. Many of these must be completed before a formal Investigational New Drug application (“IND”) is filed with the drug regulatory authorities.

Finalization of Trial Design: With pivotal input from PharmaCyte Biotech’s renowned team of oncologists, the design of its clinical trial will be finalized with the goal of creating the highest probability of developing positive data during the trial that could lead to marketing approval of its treatment for pancreatic cancer.

IND Team: An IND Team will be established to prepare the IND and review it before being formally submitted to the regulatory authorities. PharmaCyte Biotech’s IND Team, many of whom have already been retained, will include: (i) a Project Manager; (ii) a Medical Officer; (iii) a Statistician; (iv) a Chemistry, Manufacturing and Controls Expert; (v) a Pharmacologist; (vi) a Pharmakineticist; (vii) a Toxicologist; (viii) an Interventional Radiologist; (ix) a Radiologist; and (x) a Regulatory Affairs person.

Chemistry, Manufacturing and Controls Information: The manufacturing of investigational biological products are subject to stringent regulatory considerations. PharmaCyte Biotech will be working with Austrianova – the manufacturer of the encapsulated live cells used in PharmaCyte Biotech’s treatment for pancreatic cancer – to develop this information.

Clinical Protocol: A “protocol” will be prepared with by its Contract Research Organization with the invaluable assistance of PharmaCyte Biotech’s team of oncologists. The clinical protocol can be viewed as a “recipe” on how the clinical trial will be conducted. The protocol will include such things as: (i) the qualifications needed for particular patients to be included in the trial; (ii) how PharmaCyte Biotech’s treatment and the treatment used in the “comparator” arm of the study will be administered and the schedule and duration of these treatments; (iii) the specific “endpoints” for the trial and the types of data that will be collected to determine these endpoints; and (iv) the types of data analysis that will be employed in reaching conclusions about the overall success of the trial.

Pre-IND Meeting: This meeting will be requested by PharmaCyte Biotech and initiates communication with the drug regulatory authorities that will be responsible for approving its product to market. This communication is particularly important for a company like PharmaCyte biotech that is developing a new product or technology. The purpose of a pre-IND meeting is to discuss the information that will be used to prepare the IND, such as product characterization, final and in-process testing of the product, previous animal test data, prior clinical trial data and the proposed clinical protocol. Input from the regulatory authorities given during the pre-IND meeting will lead to “fine-tuning” the clinical trial protocol and will identify any additional items that may need to be included in the IND.

Clinical Trial Study Sites: Clinical study sites will be evaluated and enrolled to participate in the clinical trial. Each site will need to be multidisciplinary in nature, where medical oncologists, interventional radiologists, radiologists and other cancer specialists work together to offer multidisciplinary cancer treatments and who will work in concert in conducting their part of the clinical trial.

IND: An Investigational New Drug application will be submitted to the drug regulatory authorities before PharmaCyte Biotech can begin the clinical trial. The IND will include animal study data, toxicity (side effects that cause great harm) data, manufacturing information, the clinical protocol for the trial, data from any prior human clinical trials and information about the Principal Investigator who will oversee all aspects of the trial."

http://www.otcmarkets.com/stock/PMCB/news/PharmaCyte-Biotech-Discusses-Major-Milestones-Ahead-of-Phase-2b-Clinical-Trial-in-Pancreatic-Cancer?id=114463&b=y