September 23, 2013
Nuvilex, Inc. Designing Protocol for its Next Pancreatic Cancer Trial
Over the past two weeks, Nuvilex, Inc. (OTCQB – NVLX - $0.136 – Spec Buy) has executed huge steps that lead it onto the path that will result in the commencement of future Phase 3 clinical trials for pancreatic cancer, using its live-cell encapsulation delivery system. Although the concept of a clinical trial is understood by the layman in the general sense, the layers of complexity necessary to prepare for advanced clinical trials such as Phase 2B or Phase 3 take months or years to initiate and then can take years to complete, depending upon the trial objectives, just to name one factor of several that determine a clinical trial’s lifespan. With a great deal of experience in this vein, Nuvilex management is well on its way to designing, compiling, and completing the necessary steps in order to move forward as quickly as possible.
In addition to the work related to the establishment of a GMP facility and the production and storage of cells for clinical trial use, management is committed to completing the most critical element of the future trial, which is the clinical trial protocol. A protocol is akin to an owner’s manual or set of procedures that lies out in detailed form, the guidelines for the initiation, conduct and administration of a clinical trial.
In the case of Nuvilex, based upon its recent contract announcements, it is clear that the next trial will have 100 or more subjects (pancreatic cancer patients) in multiple sites around the globe, with those sites and administering clinicians and local investigators to be determined by Nuvilex. Of course, a Clinical Research Organization (CRO) will be tapped to prepare for and run the trial as well, which is an extremely critical function. All parties involved in conducting the trial must strictly adhere to all parameters set out in the clinical protocol that will define the entire clinical trial design and will clearly state the primary and secondary objectives of the study.
It is a bit early to forecast, but we think the best way for Nuvilex to design the trial would be a randomized, double-blind, multiple arm, multiple site, study. Some patients will be enrolled in the Nuvilex arm, which means these patients will be treated with the prodrug, ifosfamide, and the encapsulated live ifosfamide-activating cells, while in the other arm, a comparator, patients will be treated with Gemzar, which will be used as a single agent therapy. By having a double blind-trial, no one will know until the trial is over, which patients received which treatment. We envision that median survival time and one-year survival rate will be the principal objectives of the Phase 3 trial, as they were in the Phase 2 trials.
Considering that the results of the Company’s Phase 2 trials were better in terms of median survival time and one-year survival rate than those reported for the 3 approved pancreatic cancer treatments, Gemzar (gemcitabine), the combination of gemcitabine with Tarceva (erlotinib), and the combination of gemcitabine with Abraxane (albumin-bound paclitaxel) in their Phase 3 trials, if Nuvilex were to repeat its previous results in a Phase 3 trial, the Company would likely be the oncology treatment story and stock of the year.
For more information, refer to our previous NVLX Reports, Updates and Hot Topics by visiting www.GoldmanResearch.com
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Senior Analyst: Robert Goldman
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