|By Marketwired .||
|May 23, 2014 09:00 AM EDT||
NEW YORK, NY -- (Marketwired) -- 05/23/14 -- Nuvilex (OTCQB: NVLX) is calling it a "two pronged attack" on pancreatic cancer, but investors may be calling it an "end-around" or another avenue of sorts, a quicker avenue to FDA approval. This week Nuvilex peeled back another layer of its work with pancreatic cancer, and this time it was to tell the market that the well-respected Translational Drug Development (TD2) will be studying the company's pancreatic cancer treatment, the combination of Cell-in-a-Box®/ifosfamide, for the deadly disease. TD2 will study an area of great interest to the Food and Drug Administration (FDA), and an area that may be key to the FDA granting accelerated approval -- "quality of life."
Nuvilex and TD2 have begun preparing for US-based preclinical and then clinical studies on the unbearable pain and the accumulation of fluid, referred to as ascites, in the abdominal cavity. These are two commonly occurring symptoms associated with advanced pancreatic cancer as well as other abdominal cancers.
In two earlier Phase I/II clinical trials, Nuvilex's pancreatic cancer treatment was shown to reduce the size of tumors in a significant portion of those patients being treated, and thereby reduced their pain, improved their quality of life, and did so with no negative side-effects. Nuvilex and TD2 may very well be on the path to proving that the combination of Cell-in-a-Box/ifosfamide can benefit those suffering from pancreatic cancer and all other abdominal cancers where the growth of tumors is causing intense pain and where ascites is prevalent.
Nuvilex could be about to demonstrate a real breakthrough for cancer patients and increase their willingness to live with an improved "quality of life." This "quality of life" angle is a much talked about topic inside the FDA, and is a basis for accelerated approval if the studies performed by TD2 appear to provide a "clinical benefit." Accelerated approval is based on a surrogate endpoint that is reasonably likely to predict a "clinical benefit," such as prolonged life or a better "quality of life."
Although improvement in survival (being developed in Nuvilex's Phase 2b) is the gold standard, a better "quality of life" is an acceptable bases for regular approval of a drug or biological product. Drug and biological product approvals that are based on a better "quality of life" have generally included drugs or biological products that prevent or ameliorate cancer-related symptoms, including, those that prevent or relieve pain.
So, let's set the scene for investors. Preclinical studies can be relatively quick to discern a potential "clinical benefit" or to recognize an endpoint such as any amount of shrinkage in a tumor that can lead to the relief of associated pain, and the duration of time for the onset of ascites with and without the use of Nuvilex's Cell-in-a-Box/ifosfamide combination. If TD2 is successful, the company could then enter Phase 1 clinical trials in humans and again, these trials could be relatively short, and if they too are successful, Nuvilex could receive accelerated approval using Phase 1 data. Yes, companies have been granted accelerated approval based solely on Phase 1 data as the designation is designed for drugs or biological products in early phase trials.
TD2 and its world class Pancreatic Cancer Research Team (PCRT) obviously saw the results from earlier Phase I/II trials and feel Nuvilex's pancreatic cancer treatment can make a difference in the "quality of life" for those suffering what will be the second leading cancer killer in the US by 2030 according to a new report published this week in the American Association for Cancer Research's journal.
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