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NuvOx Pharma Receives FDA Orphan Drug Designation for Radiosensitizer for Glioblastoma


Tucson based pharmaceutical company NuvOx Pharma announced today that it has secured orphan drug designation from the FDA for its investigational drug NVX-108 for treatment of Glioblastoma. Orphan status provides NuvOx with development and commercial incentives such as tax credits for qualified clinical testing and market exclusivity for 7 years after the marketing approval is granted.

Tucson, AZ, December 07, 2015 --(PR.com)-- Tucson based pharmaceutical company NuvOx Pharma announced today that it has secured orphan drug designation from the FDA for its investigational radiosensitizer for glioblastoma multiforme.

Glioblastoma is the most prevalent and aggressive form of brain cancer. Over 10,000 new patients are diagnosed with glioblastoma in the U.S. each year. Despite advances in surgery, radiation, and chemotherapy, recurrence is almost a certainty, occurring on average in less than a year. Survival is poor and fewer than 10% of these patients live more than five years.

NuvOx Pharma’s CEO, Evan Unger, said: “Radiation therapy is part of the standard treatment for cancerous tumors such as glioblastoma. However, most cancerous tumors are hypoxic, and this is a problem during radiation therapy because the presence of oxygen increases the effect of radiation on tissue. NuvOx’s drug NVX-108, based on a proprietary nanotechnology platform, is designed to increase the level of oxygen in hypoxic tumors in order to increase the effect of radiation on them. By doing this, our intention is to improve the effectiveness of radiation therapy in order to increase survival and decrease recurrence. The orphan drug designation is an important regulatory advancement as we further our development efforts.” The company is currently conducting a Phase 1b clinical trial for NVX-108 in glioblastoma multiforme.

About Orphan Drug Designation:
The Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition upon the request of a sponsor. In the US, this status is granted to medicines intended for the safe and effective treatment of diseases that affect fewer than 200,000 people. Orphan status provides sponsors with development and commercial incentives such as tax credits for qualified clinical testing and market exclusivity for 7 years after the marketing approval is granted.

Disclaimer:
Certain statements in this release may constitute “forward-looking statements.” When used in this release, words like “may,” “will,” “can,” “should,” “expect,” “anticipate,” “believe,” “project,” or “intend” and other similar expressions are intended to identify forward-looking statements. Statements regarding future events and developments and future performance, as well as our expectations, beliefs, plans, or projections, are forward-looking statements which reflect only our predictions, assumptions, and estimates regarding future events and circumstances. Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.
Contact Information
NuvOx Pharma
John McGonigle
(520) 624-6688
Contact
nuvoxpharma.com

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