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Nuvilex, Inc. Phase III Clinical Trials in Strong Hands with Dr. Gerald Crabtree

Nuvilex, Inc. Phase III Clinical Trials in Strong Hands with Dr. Gerald Crabtree

Written by ι Stock Market Media — April 1, 2013

Nuvilex, Inc. (OTCQB: NVLX) CEO, Dr. Robert Ryan knew exactly what he was doing 2 years ago when he announced Dr. Gerald Crabtree would be joining his team as the company’s Chief Operating Officer (COO).  He is the right guy, at the right place, at the right time, and Dr. Ryan is expecting his COO’s extensive expertise to help carry this small biotech across the finish line.

Dr. Gerald Crabtree has spent more than forty of his 72 years studying cancer in one way or another – from his time at Brown University from 1970-1985, a period that included work in the early 1980s at the Roger Williams Cancer Center on the clinical development of a cancer drug that was further developed by Eli Lilly (NYSE: LLY), to his time in the 1990s with Bristol-Myers Squibb (NYSE: BMY) as part of the team that developed Taxol, a more than $11-billion drug for the company.

Dr. Crabtree has worked with a number of companies, each time finding himself in a crucial role in the company’s cancer research, development, and in many cases, its clinical trials, and says each experience has helped shape his understanding of the complex disease.  “I have been blessed to have known and worked with some of the major players in the cancer field and to have been involved in the development of a major cancer drug like Taxol.  But now, I am involved with something that may dwarf all of those achievements.”

And, that something is Nuvilex’s unique and proprietary cell encapsulation or “Cell-in-a-Box” technology.  The company has gone all in on “Cell-in-a-Box” with almost $30-million invested in the technology and landing Dr. Crabtree to help drive the success on its first big chance to show off in a large-scale Phase III clinical trial.  While “Cell-in-a-Box” will likely prove it can be used for the treatment of many serious, debilitating, and even deadly diseases, it’s certainly no mistake that a cancer trial in patients with advanced, inoperable pancreatic cancer using the combination of the widely used anti-cancer drug, ifosfamide, together with encapsulated cells capable of converting the ifosfamide into its “cancer-killing” form will get the first shot at proving it deserves approval by drug regulatory authorities like the EMEA in Europe and the FDA in the US.

Dr. Crabtree said, “I firmly believe that the potential of Nuvilex’s cell encapsulation technology is a true “platform” upon which treatments for many serious and even life-threatening diseases can be built.  I am particularly excited about the prospect that we may be able to substantially improve upon current treatments for advanced pancreatic cancer, one of the most deadly forms of that disease.”

His confidence likely comes from the knowledge that the technology has performed admirably in two independent Phase II clinical trials in advanced pancreatic cancer, proving “Cell-in-a-Box” not only works, but works well to this point.  Results show Nuvilex’s treatment outperforms the current single-agent standard, Eli Lilly’s drug Gemzar.  The good news for Nuvilex investors is that Dr. Crabtree has been here before, and he knows how to package the trials for success. 

“I had had a significant role in the team that developed Taxol, the number one drug under development within Bristol-Myers Squibb at the time, and a drug that became a billion-dollar “seller” shortly after its approval for marketing by regulatory authorities around the world.  In that role, I learned, among other things, just how complex late-phase clinical trials are developed, organized, and conducted.  Most importantly, during my time at Bristol-Myers Squibb, I learned about the major aspects of the overall drug development process from initial discovery through drug marketing; this is knowledge that could not have been obtained from books alone.”

He quickly put that education to good use after leaving Bristol-Myers Squibb with his work at both Epic Therapeutics, Inc. and PhytoCeutica, Inc.  It was at Epic where Dr. Crabtree says he got intimately involved with the clinical side of drug development.  He was the Consulting Project Manager for the development of the company’s prostate cancer treatment and was the direct day-to-day contact between the company and the Contract Research Organization (CRO) that was conducting the trial.

At PhytoCeutica,  Dr. Crabtree was again interacting with CROs  and assisting in the preparation of documents for the FDA that were necessary for the initiation of clinical trials of the company’s Chinese herbal medicine product that was initially designed to be an adjunct to the “gold standard” treatment for colorectal cancer at the time.  In the latter years of his time with PhytoCeutica, he attended meetings with the FDA, and assisted in clinical protocol development, clinical trial analysis and report writing, all of which concerned further development of the company’s herbal formulation for use in clinical trials in liver cancer.

He says through all of these interactions, he learned more and more about how clinical trials are conducted and the pitfalls that might occur.  “I believe the experiences that I have had will prove to be invaluable as Nuvilex moves its cell encapsulation-ifosfamide treatment forward into Phase III clinical trials and you can rest assured that I’ll put that experience to the best use possible.  In addition, my knowledge of the drug development process in general will be called upon as treatments for diseases other than pancreatic cancer are developed within the company.”

Dr. Crabtree made such an impression at PhytoCeutica that he was named CEO, and at that point, his resume and decades of studying cancer and putting cancer treatments through the paces prior to, and during, clinical trials, caught the eye of Nuvilex.  The small biotech wanted to match Dr. Crabtree’s experience with what can only be described as a “silver bullet” type technology.  If anyone can help get the company through a large scale Phase III trial, it is Crabtree.  He knows what the FDA demands, he knows what makes late-stage trials successful from early preparation to completion, and he knows about the cancer market.

When talking to Dr. Crabtree, one thing is clear – he wants to see this long- time foe meet its end.  He’s studied many aspects of cancer and has helped to develop some impressive cancer drugs, but now he has an opportunity to be part of the team that proves Nuvilex’s “Cell-in-a-Box” might just be the long needed technology that changes the way serious diseases like cancer are treated.

He also said, “We may be able to help revolutionize the way other cancers and other major diseases such as diabetes may be treated through the use of the cell encapsulation technology platform, not to mention ailments that may be treated with stem cell-based therapies.  And then there’s the new Medical Marijuana Sciences, Inc. subsidiary of Nuvilex that will be initially dedicated to developing treatments, that are based on constituents of cannabis, for brain and pancreatic cancers, two of the most “hard-to-treat” forms of the disease.”

Nuvilex has given Dr. Crabtree a new lease on life so to speak, and even at 72 years of age, he’s up to the task on this new challenge.  Nuvilex’s COO is certainly cancer patient’s gain, and investors are surely about to enjoy the ride.

“I had a dream as a young graduate student that I wanted to dedicate my life to helping people with devastating diseases and started concentrating on cancer back then.  I cannot think of a better way to close my career, and fulfill my dream, than to be where I am today.  I’m a young graduate student again – the excitement is back – maybe I’m really more like the proverbial ‘kid in a candy store,’ I guess.”