$PMCB The Phase 2b View for PharmaCyte Biotech Investors is Getting Clearer (PMCB)
PharmaCyte Biotech Inc. (OTCMKTS:PMCB) is slowly but surely making the complex simple by dishing out details one at a time. The latest round of clarity came today.
Back on September 9th, PharmaCyte Biotech Inc. (OTCMKTS:PMCB) announced it had selected a company called Imaging Endpoints to perform the task of creating, analyzing, and drawing conclusions from the necessary medical imaging (CT scans, X-rays, MRIs, etc.) of pancreatic cancer patients receiving treatment in the upcoming phase 2 trial of its experimental treatment. At the time is seemed to be just another housekeeping report - of many - regarding the launch of the study of the PMCB trial. As time has moved forward though, the importance of Imaging Endpoints' role in the trial has become clearer... and bigger. Investors who have been following the PharmaCyte Biotech saga at all may want to pay close attention to today's news regarding the medical imaging arm of the trial.
PharmaCyte Biotech is the developer of a patented biotechnology called Cell-in-a-Box(r).
In simplest terms, Cell-in-a-Box(r) is a means of encapsulating live cells -- cells grown to perform a particular function -- and implanting these pinhead-sized capsules in the body to perform a specific medical purpose. The technology has many applications, but PharmaCyte Biotech is furthest along in its development of the idea as a means of treating pancreatic cancer.
In phase 2 trials, PharmaCyte has shown that catalyzing a prodrug form of cancer-fighting therapy ifosfamide in the bloodstream in the upper part of the leg maximizes delivery of the active form of the drug to the cancer-ridden pancreas. Ergo, this approach has proven superior to activation of the drug in the liver.
While potent, ifosfamide can also cause significant side effects when taken at doses large enough to effectively fight cancer. That's because liver-activated ifosfamide must make it all the way through the entire circulatory system before it reaches the pancreas. Most of the drug never reaches the pancreatic tumor. By activating the drug in the leg, though, the activated ifosfamide only needs to travel a few inches to reach the pancreas. The end result is an impressive degree of efficacy at only one-third the normal intravenous dosage of ifosfamide.
In a phase 1/2 trial examining the benefit of the Cell-in-a-Box(r) activation of ifosfamide versus the results gemcitabine would be able to achieve alone, the Pharmacyte approach improved the median survival timeframe from 28 to 44 weeks. Equally impressive is the fact that the number of one-year survivors increased from 18% to 36% of the study's patients. The next stage of the trial - a phase 2b trial - will pit ifosfamide against the gemcitabine/Abraxane combination, which is the proverbial gold standard (for now) among pancreatic cancer treatment options.
Fast forward to today. As part of a series of articles designed to explain the drug's mechanism, activation, Cell-in-a-Box, and efficacy so far and what that means to the upcoming phase 2b test, Imaging Endpoints' Founder, Chairman and Chief Medical Officer Dr. Ronald L. Korn, MD, Ph.D. has penned some ideas as to the role he and his team will play during and after the phase 2 trial, and how they will do so.
The write-up is available in its entirety at the PharmaCyte website. But, a couple snippets from the commentary stood out.
For instance, Korn noted:
"An advantage provided by our core lab that may be utilized in PharmaCyte's Phase 2b trial, is real-time interpretations of the images rather than the more typical delayed batch reads at the end of the trial offered by most imaging core labs. This real time evaluation helps to ensure any imaging related problems are identified and corrected real-time, and it is often necessary to make sure there is an objective, uniform determination of response or progression....For example, it is not uncommon for local radiologists and oncologists to share information during the care of a patient that might bias the local radiologist's interpretation of the imaging data. This may inappropriately impact the PI's decision to continue or remove patients from the trial. However, when images are reviewed real-time by the central radiologist expert, this unbiased data can be made available to the local PI under certain conditions. If the central radiology is reviewed at the end of the trial rather than in real-time, then the oppo rtunity can be lost to inform the local investigator in this manner. As a result, patients may be left on trial or taken off trial inappropriately (a process known as informative censoring). Our real-time evaluations may reduce informative censoring that can sometimes mask a treatment's success."
Dr. Korn also stated:
"At Imaging Endpoints, we use state-of-the-art approaches to measure treatment efficacy providing evaluations far beyond RECIST. One such approach that we have focused upon in our core lab is change in tumor architecture driven by drug treatments....For this type of analysis, we use a proprietary software analysis technology that interrogates the appearance of tumors on CT/MRI and PET and extracts the individual image elements (digital information on a pixel level that make-up the images of a scan that a physician reviews), and transforms this digital information into histogram-frequency curves. As a result, we can quantitate the extent to which the internal architecture has changed following therapy. This type of imaging biomarker analysis is called quantitative textural analysis or QTA."
In reading the commentary, it becomes clear that the imaging aspect of the trial may become the centerpiece of the trial. Interested investors should examine Korn's article in its entirety here.
For more on Pharmacyte Biotech, visit the company website here.
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