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)

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)

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

Carissa Schumacher, +1-310-499-8970, novarx@novarx.com, for NovaRx
Corporation