Press Releases:

08.21.08

NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients

SAN DIEGO, CA – August 21, 2008 – NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix® (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC). The first patient enrolled in the study was treated by Dr. Lyudmila Bazhenova the trial’s principal investigator at the University of California, San Diego School of Medicine.

The study is designated as the STOP trial because of its expected endpoints: Survival; Tumor-free, Overall; and Progression-free. It is an international, multicenter, randomized, double-blind study involving up to 700 individuals with advanced stage NSCLC, and will be conducted at approximately 90 clinical sites in the U.S., Canada, India, and Europe.

In a Phase II clinical trial, two-year survival among patients with stages IIIB and IV disease who received Lucanix® was significantly longer than that of individuals being treated with the current standard of care. A second, investigator-initiated phase II study supported these results.

In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, the therapeutic vaccine developed by NovaRx induces the patient’s immune system to specifically target the cancer. In phase II clinical studies to date, the side effects of this treatment have included redness or soreness at the injection site.

“In medical research, you see something like this once in a lifetime,” said John Nemunaitis, M.D., executive director at the Mary Crowley Medical Research Center in Dallas, TX and principal investigator of both the Phase II Lucanix® study and the investigator-initiated Phase II trial.

“This is a very promising approach to cancer treatment, and results reported so far are beyond anyone’s expectations. I am very excited to be a part of this confirmatory effort, and to be able to offer this unique treatment option to my patients,” said Dr. Lyudmila Bazhenova, principal investigator of the STOP trial at the Rebecca and John Moore’s Cancer Center of UCSD. “Traditional chemotherapy for stage IV NSCLC still yields disappointing results, and my hope is that this trial will improve the natural history of the disease.” The FDA granted NovaRx Fast-Track approval for the Lucanix® trial in March of 2007, and Special Protocol Assessment approval in January of 2008.

According to the American Cancer Society, in 2008 there will be an estimated 215,000 new cases of lung cancer diagnosed, and 162,000 deaths caused by this disease in the United States alone. Lung cancer is the number one cause of cancer death throughout the world. “The statistics for global lung cancer deaths are staggering. I am confident that this Phase III trial will establish Lucanix® as a viable treatment option for patients with this dreaded disease,” said Dr. Habib Fakhrai, president and co-founder of NovaRx.

In Phase II testing, 50 percent of patients entering the trial with stable disease who received Lucanix® following one frontline regimen of chemotherapy lived more than 44 months, compared to less than 10-12 months for such patients under the current standard of care. In addition, patients with advanced disease who received Lucanix® after zero to five prior chemotherapy treatments demonstrated a one-year survival of 61 percent and a two-year survival of 41 percent. Such late-stage patients typically demonstrate one-year survival of less than 30 percent. Lucanix® was shown to produce only insignificant side effects.

“In addition to significantly increased survival,” Fakhrai continued, “we saw virtually no side effects in the patients treated in phase II trials. Based on our previous trial results, we think Lucanix® may lead to a significant advancement in patient care. We look forward to continuing to enroll patients in this very important clinical study.”

“We are delighted to have been selected as one of the major centers to test this highly promising immunotherapeutic approach to treating individuals with NSCLC,” said Dr. Julian Molina, principal investigator of the STOP Trial at Mayo Clinic in Rochester, Minnesota.

Lucanix® consists of four non-small cell lung cancer cell lines that have been genetically engineered to shut off their immune suppressive properties. These cell lines are then modified to block a molecule called transforming growth factor-beta (TGF-beta), which is commonly produced by cancer cells as a cloak against the body’s natural immune system. When TGF-beta is blocked, the immune system can mount an anti-tumor response. The results of Phase II testing were published in the October 10, 2006 edition of the Journal of Clinical Oncology.

Studies to test the therapeutic vaccine in other types of cancer are also in progress. “NovaRx remains committed to developing whole cell-based therapeutic vaccines for any form of cancer in which this approach may significantly improve patient outcomes by either curing their disease entirely, or by stabilizing it over the course of their lives,” said Justin Murdock, CEO and chairman of the board of NovaRx.

Founded in 1997, NovaRx Corp. 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 24,000 square foot headquarters in San Diego, CA, house corporate offices and manufacturing operations. The proprietary core technology upon which Lucanix® is based has been exclusively licensed to NovaRx on a worldwide basis. Lucanix® is a trademark of NovaRx Corp.

For more information on the NovaRx Lucanix® Phase III STOP Trial in NSCLC please visit NovaRx.com.

Patients interested in learning more about the STOP trail or how to enroll should call 1-866-949-5864 (949-LUNG).
Media please call: 1-866-950-5864 (950-Lung).

06.05.06

Lucanix Phase II Clinical Data Demonstrates Significantly Increased Survival in Lung Cancer Patients:

ATLANTA, ASCO, June 5 -- NovaRx Corporation announced at the American Society of Clinical Oncology ("ASCO") meeting in Atlanta, GA, that data from the Company\'s Phase II clinical trial treating individuals with advanced stages of non-small cell lung cancer ("NSCLC") demonstrated two year-survival more than four times that of individuals treated with the current standard of care. The Phase II study of 75 patients was designed to determine the safety and efficacy of Lucanix™, a novel therapeutic treatment under development by NovaRx. In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill the normal cells as well as tumor cells, the therapeutic vaccine developed by NovaRx specifically induces the patient\'s immune system to fight the cancer. In clinical studies to date, the side effects of this treatment have been shown to be minimal compared to those associated with traditional therapies.

"These data are extremely encouraging," said John Nemunaitis, M.D., Executive Director at the Mary Crowley Medical Research Center in Dallas, TX, a clinical investigator and presenter of the Lucanix study results. "In addition to significantly increased survival rates, which is the gold standard for oncology clinical trials, we saw virtually no side effects with Lucanix. The unique mechanism of action and resulting efficacy and side effect profile could lead to a significant advancement in patient care. We look forward to initiating Phase III trials."

"The compelling data presented by Dr. Nemunaitis demonstrate that further testing of Lucanix may lead to a commercially viable, effective treatment for this deadly disease," said Dr. Habib Fakhrai, Ph.D., President and CEO of NovaRx and the inventor of the Company\'s technology. "We are in the final stages of preparing to initiate a pivotal, Phase III trial to test Lucanix in a two-arm, controlled study in approximately 400 individuals with advanced stages of NSCLC."

The therapeutic vaccine being developed by NovaRx consists of four non-small cell lung cancer cell lines that were originally derived from lung cancer patients. These cell lines were engineered to block a molecule called transforming growth factor-beta (TGF-Beta), which is a potent agent commonly produced by cancer cells that paralyzes the patients\' immune system. Lucanix has been previously shown to induce immune-mediated antitumor responses in cancer patients, thus "jumpstarting" their immune response. The Phase II data demonstrate that the vaccine significantly improved survival in lung cancer patients by destroying, halting, or delaying disease progression.

There are 170,000 new cases of lung cancer and 160,000 deaths caused by this disease in the United States annually. Non-small cell lung cancer is responsible for approximately 130,000 of lung cancer deaths in the U.S. each year and is the number one cause of cancer death throughout the world.

NovaRx Corporation is a privately held biopharmaceutical company based in San Diego, California. The company is developing new therapeutic approaches for treating cancer with its lead indication focused on non-small cell lung cancer. NovaRx Corporation holds the exclusive worldwide license for this patented technology for the treatment and prevention of all cancers and plans to develop therapies for lung, brain, breast, colon, prostate and melanoma cancers. Patents have been issued in the U.S., Europe and Japan that protect the Company\'s intellectual property. Additionally, the Company is planning to initiate a multi-center pivotal Phase II/III clinical trial treating individuals with glioblastoma multiforme or gliosarcoma (brain cancers) in 2008. The Company is the recipient of two National Institutes of Health grants. Proceeds from these grants will partially offset the cost of the Phase II lung cancer trial and the planned pivotal Phase II/III brain cancer trial.

Lucanix™ is a trademark of NovaRx Corporation.

For more information on the company, please contact Kathy Witz Sweeney with Mentus at 858-455-5500, kwitz@mentus.com, or visit the NovaRx website at www.novarx.com.

 

05.31.06

NovaRx To Present Lucanix™ Phase II Clinical Data at ASCO:

NovaRx Corporation announced today that data from the Company’s Phase II clinical trial treating individuals with advanced stages of non-small cell lung cancer (“NSCLC”) will be presented on June 4, 2006, at the American Society of Clinical Oncology (“ASCO”) meeting in Atlanta, GA. The Phase II study
was designed to determine the safety and efficacy of Lucanix™, a novel therapeutic treatment under development by NovaRx. In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill the tumor and normal cells, the therapeutic vaccine developed by NovaRx specifically induces the patient’s immune system to attack the tumor. In clinical studies to date, the side effects of this treatment have been minimal
compared to the severe side effects associated with traditional therapies.

Habib Fakhrai, Ph.D., President & CEO of NovaRx and the inventor of the technology, said “We are pleased that ASCO has provided the company with the opportunity to present the data from our completed Phase II clinical trial for individuals with NSCLC.”

John Nemunaitis, M.D., Executive Director of the Mary Crowley Medical Research Center in Dallas, TX and one of the three principal clinical investigators of the trial, will be the presenter of NovaRx’s Lucanix™ study results.

The therapeutic vaccine being developed by NovaRx consists of four non-small cell lung cancer cell lines that were originally derived from lung cancer patients. These cell lines have been engineered to block production of transforming growth factor-beta (TGF-Beta). TGF-Beta is a potent agent commonly produced by cancer cells that paralyzes the patients’ immune system, thus preventing an anti-tumor response. Lucanix™ was shown to induce immune-mediated antitumor responses in NSCLC cancer patients and to delay disease progression.

There are 170,000 new cases of lung cancer and 160,000 deaths caused by lung cancer in the United States annually. Non-small cell lung cancer is responsible for approximately 130,000 lung cancer deaths in the U.S. each year and is the number one cause of cancer death throughout the world.

NovaRx Corporation is a privately held biopharmaceutical company based in San Diego, California. The company is developing new therapeutic approaches for treating cancer with its lead indication focused on non-small cell lung cancer. NovaRx holds the exclusive worldwide license for this patented technology for the treatment and prevention of numerous indications, including but not limited to lung, brain, breast, colon, prostate and melanoma cancers. Patents have been issued in the U.S., Europe and Japan that protect the Company’s intellectual property. Additionally, the Company is planning to initiate a multi-center pivotal Phase II/III clinical trial treating individuals with glioblastoma multiforme or gliosarcoma (brain cancers) in the second half of 2007. The Company is the recipient of two National Institutes of Health grants. Proceeds from these grants will partially offset the cost of the planned pivotal Phase II/III brain cancer trial.

Lucanix™ is a trademark of NovaRx Corporation.

For more information on the company, please contact Kathy Witz Sweeney with Mentus at 858-455-5500, kwitz@mentus.com, or visit the NovaRx website at www.novarx.com.

09.08.04

The Immune Response Corporation and NovaRx Corporation Announce Revision of Licensing Agreement for Cancer Cell Line Vaccines:


Carlsbad and San Diego, CA - September 8, 2004 -- The Immune Response Corporation (Nasdaq: IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), and NovaRx Corporation, a privately-held company dedicated to developing therapeutic vaccines to treat cancer, announced today they signed a licensing agreement to transfer all of The Immune Response Corporation\'s in-licensed development and marketing rights of the Sidney Kimmel Cancer Center\'s (SKCC) patent portfolio for cancer cell line vaccines to NovaRx. In addition, NovaRx agreed to pay The Immune Response Corporation the total sum of $1,050,000, including an upfront fee and a final payment due on or before August of 2007. The Immune Response Corporation had previously licensed the cancer cell vaccine technology from SKCC in 1994.

"When I joined the company early last year, we began a strategic re-focus of The Immune Response Corporation in the areas of HIV and MS and this transaction further supports that business objective," said John N. Bonfiglio, Ph.D., Chief Executive Officer of The Immune Response Corporation.

"We are focused exclusively on the development of cancer vaccines and are delighted that we will be in a position to realize increased profitability through royalty reduction once the products under development become commercially available." said Habib Fakhrai, Ph.D., President and CEO of NovaRx Corporation. "As one of the inventors of the technology, I have already worked with SKCC successfully on both our brain cancer and lung cancer therapeutic vaccines. Our product to treat individuals with non-small cell lung cancer is in a Phase II clinical trial, which has been fully enrolled 14 months ahead of schedule, and we look forward to the further expansion of our cancer research as a result of this agreement."

In 1997, The Immune Response Corporation sublicensed a portion of the SKCC patented technology to NovaRx for their exclusive use in treating a variety of cancers, and has received milestone payments related to those licenses. The previously licensed technology specifically covers blocking activity of a potent immune suppressive cytokine, called Transforming Growth Factor-Beta (TGFB), which is produced by tumor cells. When this potent immune suppressor is present in the vaccine, it suppresses the ability of the vaccine\'s tumor cell lines to stimulate immune responses to the patient\'s tumor.

The terms of the agreement state that NovaRx will acquire The Immune Response Corporation\'s exclusive rights to SKCC\'s patent portfolio for cancer cell line vaccines, and the exclusive rights to a key immortalized fibroblast cell line for use with this technology. In return, NovaRx assumes all responsibilities, liabilities, and financial obligations defined under both of The Immune Response Corporation\'s previous agreements with SKCC and the exclusive license to the immortalized fibroblast line for use with the technology.

About NovaRx

NovaRx Corporation is a privately-held biopharmaceutical company based in San Diego, California. The company is dedicated to developing new therapeutic approaches for treating cancer with its lead indication focused on non-small cell lung cancer, which is responsible for approximately 170,000 deaths in the U.S. each year and is the number one cause of cancer death throughout the world. Additionally, the company is planning to initiate a multi-center pivotal Phase II/III clinical trial treating individuals with brain cancer in 2005.

Additional information on the company is available at www.novarx.com

 

05.18.04

NovaRx Achieves Full Enrollment of its Phase II Clinical Trial in Non-Small Cell Lung Cancer Ahead of Schedule:

SAN DIEGO, May 18, 2004 /PRNewswire/ -- NovaRx Corporation announced today that it has successfully achieved full enrollment over a year ahead of schedule in its multi-center Phase II clinical trial treating individuals with advanced stages of lung cancer. The Phase II study is designed to determine the safety and efficacy of a novel therapeutic concept under development by NovaRx. In contrast to conventional cancer therapies, where chemotherapeutic drugs destroy the tumor, the therapeutic vaccine developed by NovaRx enhances the patient\'s own immune system in order to fight the cancer. In clinical studies to date, the side effects of this treatment have been shown to be far less than those associated with traditional therapies.

"The accelerated enrollment in this trial is extremely encouraging and is a strong indication of the fact that the clinical investigators are hopeful that NovaRx\'s therapeutic vaccine being tested may lead to an effective treatment of this deadly disease," said Dr. Habib Fakhrai, President and CEO of NovaRx.

The therapeutic vaccine being developed by NovaRx consists of non-small cell lung cancer cell lines that were originally derived from lung cancer patients. These cell lines are genetically modified through the introduction of a gene that blocks a molecule called transforming growth factor-beta (TGF-Beta). TGF-Beta is a potent agent commonly produced by cancer cells that paralyzes the immune system. The vaccine has been previously shown to induce therapeutic immune responses in cancer patients and it is believed that this will significantly extend survival by destroying, halting, or delaying progression of the disease.

NovaRx Corporation holds the exclusive worldwide license for this patented technology for the treatment and prevention of numerous indications, including but not limited to lung, brain and colon cancers.

NovaRx Corporation is a privately held biopharmaceutical company based in San Diego, California. The company is dedicated to developing new therapeutic approaches for treating cancer with its lead indication focused on non-small cell lung cancer, which is responsible for approximately 170,000 deaths in the U.S. each year and is the number one cause of cancer death throughout the world. Additionally, the company is planning to initiate a multi-center pivotal Phase II/III clinical trial treating individuals with brain cancer in 2005. Last week the company announced that it was the recipient of an additional National Institutes of Health grant totaling $2.2 million over a four year period. The proceeds from this grant will partially offset the cost of the pivotal Phase II/III brain cancer trial. Brain cancer affects over one million people worldwide.

 

05.12.04

NovaRx Announces $2.2 million Award of SBIR Grant to Help Fund its Pivotal Phase II/III Clinical Trial in Brain Cancer:

SAN DIEGO, May 12, 2004 /PRNewswire/ -- NovaRx Corporation announced today that it has been awarded $2.2 million in funding from the National Institutes of Health (NIH) via a new SBIR grant. This grant will provide a portion of the capital needed for the company to conduct a pivotal Phase II/III clinical trial to test the company\'s proprietary therapeutic vaccine to treat brain cancer, and is payable over a four year period. The company plans to initiate the pivotal brain cancer trial in 2005. NovaRx is currently in active discussions with both private investors and corporate partners to secure additional capital to complete the development of both its brain and lung cancer treatments, and to advance a therapeutic vaccine to treat colorectal cancer into mid-late stage development.

"We are extremely pleased that the therapeutic approaches to treating cancers that are being developed by NovaRx continue to be recognized by the NIH as being important enough to be awarded additional funding," said Habib Fakhrai, Ph.D., NovaRx\'s President and CEO.

NovaRx is currently conducting a multi-center Phase II clinical trial treating individuals with advanced stages of lung cancer. The therapeutic vaccine being tested consists of non-small cell lung cancer cell lines that have been genetically modified with technology called transforming growth factor-beta (TGF-Beta) antisense. TGF-Beta is a potent agent commonly produced by cancer cells that helps the cells hide from the immune system. TGF-Beta antisense is a technology that blocks the production of TGF-Beta by the cancer cells. NovaRx Corporation holds the exclusive worldwide license for this technology for the treatment and prevention of numerous cancers.

NovaRx Corporation is a biopharmaceutical company based in San Diego, California. The company is dedicated to developing new therapeutic approaches for treating cancer and is presently focused on lung cancer, which is responsible for approximately 170,000 deaths in the U.S. alone each year and is the number one cause of cancer death throughout the world, and brain cancer, which affects approximately 1 million individuals worldwide.

 

04.02.04

NovaRx Corporation of San Diego, CA and Hoag Cancer Center of Newport Beach, CA Announce the Start of a Phase II Clinical Trial in Lung Cancer:

SAN DIEGO, Feb. 4 /PRNewswire/ -- NovaRx Corporation announces a collaboration with Hoag Cancer Center of Newport Beach, California to conduct a Phase II clinical trial using an experimental cancer vaccine in patients with lung cancer.

Dr. Robert Dillman, Medical Director of Hoag Cancer Center, is the principal investigator. Dr. Habib Fakhrai, President and Chief Executive Officer of NovaRx and developer of the award-winning technology being tested in the clinical trial, is the sponsor. Both the principal investigator and the sponsor are leaders in developing new therapies in the field of oncology.

The experimental lung cancer vaccine that will be evaluated in the trial consists of non-small cell lung cancer cell lines that have been genetically modified with technology called transforming growth factor-beta (TGF-Beta) antisense. TGF-Beta is a potent agent commonly produced by cancer cells that helps the cells hide from the immune system. TGF-Beta antisense is a technology that blocks the production of TGF-Beta by the cancer cells.

NovaRx Corporation holds the exclusive worldwide license for this technology in lung cancer.

In April 1996, researchers at the University of California, Los Angeles and Sidney Kimmel Cancer Center in San Diego published data from animal studies in the "Proceedings of the National Academy of Sciences." "The results from the preclinical studies were extremely encouraging. We have since performed a Phase I clinical trial in highly advanced brain tumor patients, also with encouraging results," said Dr. Fakhrai.

NovaRx Corporation is a biopharmaceutical company based in San Diego, California. The company is dedicated to developing new therapeutic approaches for treating cancer and is presently focused on lung cancer, which is responsible for approximately 160,000 deaths in the U.S. each year and is the number one cause of cancer death throughout the world.