SAN DIEGO, Sept. 25, 2013 /PRNewswire-iReach/ -- NovaRx Announces Results of Lucanix® Phase III Therapeutic Vaccine Trial for Post-frontline Maintenance Therapy in Non-small Cell Lung Cancer to Be Presented at ESMO.
(Photo: http://photos.prnewswire.com/prnh/20130925/MN85848)
NovaRx Corporation announced that the detailed results from the randomized Phase III trial of Lucanix® (belagenpumatucel-L) post-frontline maintenance therapy in non-small cell lung cancer will be presented at the European Society for Medical Oncology 2013 annual meeting in Amsterdam. The results will be presented in “Presidential Session I: Best and Late Breaking Abstracts” on 28 September 2013, which starts at 1:45 pm.
The primary endpoint of improving overall survival in 532 patients was not met primarily due to the inclusion of patients more than 12 weeks following the completion of frontline chemotherapy. In this predefined subgroup of 305 stage IIIB/IV patients, a median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control (HR 0.75). In a the predefined subgroup of these patients with a histology of squamous cell carcinoma a media survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control (HR 0.58). In the predefined subgroup of these patients who received radiation therapy prior to enrollment a media survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control (HR 0.45).
About the Study Design
Lucanix is an investigational whole tumor cell vaccine for the treatment of non-small cell lung cancer. The clinical trial was an international, multicenter, randomized, double-blind, placebo-controlled Phase III study, which enrolled 532 patients with advanced non-small cell lung cancer who did not progress following frontline chemotherapy.
About Non-small Cell Lung Cancer
Non-small cell lung cancer is the leading cause of death among cancers. In the United States approximately 160,000 people die from lung cancer each year, more than the next four most lethal forms of cancer combined. Worldwide, close to two million people are expected to die from lung cancer this year. Currently only a handful of treatment options are available to people with lung cancer, most of which have significant toxic side effects. Lucanix can provide an alternative option to these drugs.
About Lucanix Whole Tumor Cell Vaccine
Lucanix may represent the first product in a new class of tumor vaccines designed to use whole tumor cells to stimulate the patient’s own immune system to attack the patient’s tumor. Lucanix is an off-the-shelf allogeneic vaccine unlike other cellular immunotherapies. The tumor cells in Lucanix have been modified to block production of transforming growth factor beta (TGF-), which is one of the primary methods tumors use to hide from the immune system. Blocking TGF- is designed to allow the vaccine to initiate strong immune responses with the goal of inducing a long-term clinical benefit with minimal toxicity.
About NovaRx
NovaRx Corporation is a private biotechnology company whose mission is to develop novel tumor cell vaccines characterized by strong efficacy with little toxicity. The Company views its TGF--blocking technology as a platform and is developing a universal tumor cell vaccine that effectively targets all forms of cancer and can be used therapeutically or prophylactically. The Company is headquartered in San Diego, California. For more information about NovaRx, visit www.NovaRx.com.
This press release contains forward-looking statements that are subject to risks and uncertainties surrounding the safety and efficacy of Lucanix to treat people with non-small cell lung cancer. There are also inherent risks and uncertainties surrounding the approval of a new drug product by FDA or EMA.
Media Contact:Habib Fakhrai, NovaRx Corporation, 858-336-1915, fakhrai@novarx.com
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SOURCE NovaRx Corporation
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