Navigation Links
NovaRx Corporation Announces FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix(R) Study in Non-Small Cell Lung Cancer (NSCLC)
Date:11/4/2009

SAN DIEGO, Nov. 4 /PRNewswire/ -- NovaRx Corporation announced today that the Company has successfully negotiated and received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to the pivotal Lucanix® Phase III clinical trial in patients with Non-Small Cell Lung Cancer (NSCLC). The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, thus the amendment will make significantly more patients eligible for the trial. Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels.

"We are very excited by the approval of this protocol amendment," stated Justin Murdock, CEO of NovaRx. "It confirms the FDA's willingness to work with us in the Phase III process, enables the trial's clinical sites and investigators to screen more patients, and, most importantly, will make far more patients eligible for the study. Reaching and potentially benefitting as many patients as possible is NovaRx's utmost priority."

"The protocol amendment will strengthen the Lucanix®( )Phase III study greatly," said Dr. Habib Fakhrai, Executive Vice Chairman of the Board and Chief Scientific Officer of NovaRx. "We thank the FDA for the speed in which they approved the amendment and look forward to continuing to successfully work with them and our clinical sites throughout this pivotal Phase III trial."

According to the American Cancer Society (ACS), lung cancer is the single largest cause of cancer deaths among men and women in the United States and is responsible for nearly 30 percent of all cancer deaths. The ACS estimates that in 2009 more than 200,000 Americans were diagnosed with lung cancer and close to 160,000 died of the disease. NSCLC is the most common type of lung cancer.

About Lucanix®:

In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, Lucanix® induces the patient's immune system to specifically target the cancer.

Lucanix® consists of four non-small cell lung cancer cell lines that have been gene-modified to block a molecule called transforming growth factor-beta (TGF-beta), which is commonly produced by cancer cells. The molecule allows cancer to hide from the body's natural immune system. When TGF-beta is blocked, the immune system can see, find, and destroy the cancer naturally.

United States Food Drug Administration granted NovaRx Fast-Track approval for the Phase III Lucanix® trial in March of 2007, and Special Protocol Assessment approval in January of 2008. The Phase III study commenced in August 2008 and over 90 global clinical sites are expected to enroll NSCLC patients in the trial.

Lucanix® is currently under clinical investigation and has not been approved for use in the United States, Canada, Europe or elsewhere. Any claims of safety and efficacy can only be made after the FDA reviews the data and approves all labeling claims for Lucanix®'s intended use.

About NovaRx Corporation

NovaRx Corporation is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel cell-based therapeutic vaccines for the treatment of cancer. The company's headquarters and manufacturing operations are in San Diego, California. The proprietary core technology upon which Lucanix® is based has been exclusively licensed to NovaRx on a worldwide basis. Lucanix® is a registered trademark of NovaRx Corporation.

Although the company's current clinical trials are for the treatment of advanced non-small cell lung cancer, the majority of other forms of cancer are expected to be susceptible to NovaRx's vaccine approach. NovaRx is in discussions with the FDA to initiate a clinical trial for one of its promising pipeline vaccines, Glionix(TM), for the treatment of brain cancer. A version of this vaccine has already been tested in patients with provocative results.

CONTACT: Carissa Schumacher for NovaRx Corporation at +1-310-499-8970 or novarx@novarx.com

SOURCE NovaRx Corporation


'/>"/>
SOURCE NovaRx Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Amerigroup Corporation to Present at the 18th Annual Credit Suisse Healthcare Conference on November 12
2. MDS Inc. and Danaher Corporation Receive Second Request for Information from U.S. Federal Trade Commission for MDS Analytical Technologies Sale
3. Triple-S Management Corporation Reports Third Quarter 2009 Results
4. Service Corporation International Announces Schedule for Its Third Quarter 2009 Earnings Release and Conference Call
5. COMFORCE Corporation to Hold Conference Call to Discuss Third Quarter 2009 Results
6. Addus HomeCare Corporation Prices Initial Public Offering
7. Zix Corporation Hits High End of Financial Guidance as Company Announces Third Quarter 2009 Financial Results
8. HLTH Corporation Announces Completion of Sale of Porex Unit to Aurora Capital Group
9. China Medicine Corporations Levocarnitine Dried Powder Injection Was Registered with the Ministry of Health of Pakistan
10. Micro-Waste Corporation Ordered to Pay Sanitecs Attorney Fees
11. Kimberly-Clark Announces Definitive Agreement to Acquire I-Flow Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... ... December 09, 2016 , ... MEDI+SIGN®, ... announced today that a new solution for Emergency Departments (ED) has been added ... space in Emergency Department examination rooms, and with a simplified pallet of information ...
(Date:12/8/2016)... ... December 08, 2016 , ... After enjoying record-breaking ... registration today for its 33rd Annual Issues & Research Conference, March 2-3, ... theme of the conference is “Persistent Challenges and New Opportunities: Using Research to ...
(Date:12/8/2016)... ... December 08, 2016 , ... CURE Media Group, the ... advocacy groups, has aligned with Upstage Lung Cancer in efforts to combat lung cancer, ... Michael J. Hennessy, Jr said, “CURE Media Group is honored to team up with ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... to its innovative Unified Instance Manager architecture, meeting the needs of multichannel ... version optimizes the unattended auto-dialing system without agents, Presence Robodialer, provides greater ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... after surgery as possible. With this in mind, SIGVARIS has created a new ... blood clot) during bed rest and provide the benefits of graduated compression when ...
Breaking Medicine News(10 mins):
(Date:12/9/2016)... , Dec. 9, 2016  RxWiki Inc., a digital ... digital marketing strategies of thousands of pharmacies through its ... Austin Inno,s "50 on Fire" Award in ... "We,re pleased to accept the award as one of ... Chief Executive Officer at RxWiki. "Our platform gives independent ...
(Date:12/8/2016)... , Dec. 8, 2016 IRIDEX Corporation (NASDAQ: ... newly issued shares of common stock, $0.01 par value (the ... underwritten public offering.  The final terms of the Offering will ... pricing, and there can be no assurance as to whether ... expects to use the net proceeds it will receive from ...
(Date:12/8/2016)... , Dec. 8, 2016 Global Interventional ... on the global interventional radiology market analyzes the ... report comprises an elaborate executive summary, including a ... segments and sub-segments. The research is a ... formed the bulk of our research efforts along ...
Breaking Medicine Technology: