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:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily by ... and deal with these stressors is to adopt a more healthful diet, but too ... Risa Groux, a certified Holistic Nutritionist and the creator of the Newport Beach Cleanse ...
(Date:4/29/2016)... ... 2016 , ... The White House announced efforts yesterday to ... about their loan terms and accounts, and more protections for borrowers. The announcement ... private loans, has reached $1.3 trillion, with 43 million Americans holding student loans ...
(Date:4/29/2016)... Texas (PRWEB) , ... April 29, 2016 , ... Spine ... neck pain, is proud to announce one of their physicians has been invited to ... Family Physicians (Texas ACOFP) Family Practice Review conference on April 30, 2016. , ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Gluten-Free ... is pleased to announce the launch of the GFCP Scoop in ... more. The purpose of the GFCP Scoop site is to keep ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Reltok Nasal ... and products for the head and neck/ear, nose and throat specialty, has added the ... The KOTLER NASAL AIRWAY™ is a newly patented safety device secured by ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... April 28, 2016 Research and ... Plastic Surgery Products Market 2016-2020" report to their ... , The global plastic surgery products market ... during the period 2016-2020. , ,The growing adoption of ... the growth of the market. Lasers are used to ...
(Date:4/28/2016)... -- The blood testing market in China ... and The Freedonia Group in a recent report.  The ... healthcare research firm said that China ... and in improving testing at the provincial level.   The ... Blood Testing Market in China , which utilized ...
(Date:4/28/2016)... Dr. Vivek Ahuja , ... Ste phen Schmidt Join the ... software solutions for life sciences, today announced key new leaders have ... insight to a growing business.  This will bolster the company,s safety ... joined ArisGlobal in the position of Vice President - Safety. ...
Breaking Medicine Technology: