FDA Grants Orphan Drug Designation to Nuvilex, Inc. for Pancreatic Cancer Treatment
SILVER SPRING, Md., Dec. 22, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment. Nuvilex’s pancreatic cancer treatment combines Nuvilex’s patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box(R), with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form. These capsules are ...
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22
DEC
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Nuvilex’s Cancer Treatment Obtaining FDA Orphan Drug Status Would Make Company Attractive Big Pharma Target
Written by Ι Stock Market Media Group Staff — October 14, 2014
New York, NY – Nuvilex, Inc. (OTCQB: NVLX) has officially introduced its advanced pancreatic cancer treatment to the U.S. Food and Drug Administration (FDA) in an application asking the agency to grant orphan drug status to its Cell-in-a-Box/ifosfamide combination for the rare disease.
The FDA’s orphan drug program designates a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 ...
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14
OCT
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Nuvilex Adds World Renowned Oncologist and Gastroenterologist to Play Major Role in Late Phase Clinical Trial
SILVER SPRING, Md., May 1, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that world renowned oncologist and gastroenterologist Professor Dr. Matthias Lohr of the famed Karolinska Institute in Stockholm, Sweden, has agreed to play a major role in Nuvilex’s Phase 2b clinical trial in pancreatic cancer to be conducted in Australia, as well as other clinical studies and trials in which Nuvilex will be involved. Dr. ...
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1
MAY
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Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment without Competition
Written by ι Stock Market Media Group — April 22, 2014
When Nuvilex, Inc. (OTCQB: NVLX) named Clinical Network Services (CNS) as the Contract Research Organization (CRO) for its late phase clinical trials in advanced pancreatic cancer, the company also stated it will apply for “Orphan Drug” status. This is a designation that will allow Nuvilex to exclusively market its pancreatic cancer treatment using the Cell-in-a-Box® technology combined with the anticancer drug ifosfamide.
Treatments for pancreatic cancer engender an Orphan Drug designation in most ...
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22
APR
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Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial
Written by ι Stock Market Media Group Staff — April 17, 2014
Nuvilex, Inc. (OTCQB: NVLX) has once again delivered a major announcement as it advances its pancreatic cancer treatment toward late phase clinical trials. Nuvilex continues to put forth what is turning into a well thought out game plan for the future of treating advanced pancreatic cancer. It’s a game plan that could include obtaining accelerated FDA approval of its pancreatic cancer treatment if it can produce the same strong results in an announced ...
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17
APR
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Nuvilex Investors Should Read Between the Lines as Company Attracts World Renowned Oncologist
Written by ι Stock Market Media Group Staff — April 3, 2014
NEW YORK, NY–(Apr 3, 2014) – That loud noise you hear coming from Nuvilex, Inc. (OTCQB: NVLX) this week is the collective excitement of many investors after the company stated it would be working with Translational Drug Development or TD2 and Dr. Daniel Von Hoff, the world’s leading figure in pancreatic cancer, to develop its pancreatic cancer and other treatments utilizing Cell-in-a-Box® technology. Quite honestly Nuvilex may have just announced what ...
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3
APR
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