NovaRx Corporation Announces Results of Lucanix® Phase III Therapeutic Vaccine Trial for Maintenance Therapy in Non-small Cell Lung Cancer to be Presented at ESMO.
Published: Sep 26, 2013
SAN DIEGO, Sept. 26, 2013 /PRNewswire/ -- NovaRx Corporation announced that the results from the randomized Phase III trial of Lucanix® (belagenpumatucel-L) will be presented at the European Society for Medical Oncology 2013 annual meeting in Amsterdam. The results will be presented by Dr. Giuseppe Giaccone in "Presidential Session I: Best and Late Breaking Abstracts" on 28 September 2013.
The primary endpoint of improving overall survival in 532 patients was not met. However, in the predefined subgroup of 305 stages IIIB/IV patients enrolled within 12 weeks of the completion of frontline chemotherapy, a median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control (HR 0.75). In a predefined subgroup of these patients with squamous cell carcinoma a median survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control (HR 0.58). In another predefined subgroup of these patients who received radiation therapy prior to enrollment a median survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control (HR 0.45). The endpoint was not met due to patients enrolled more than 12 weeks following the completion of chemotherapy.
About Lung Cancer
Each year lung cancer causes approximately 160,000 deaths in the USA and close to two million deaths worldwide, more than the next four most lethal cancers combined.
About Lucanix Whole Tumor Cell Vaccine
Lucanix represents a new class of tumor vaccines designed to use allogeneic whole tumor cells to stimulate the patient's own immune system to attack the patient's tumor. The cells in Lucanix have been modified to block production of transforming growth factor beta (TGF-B), which is one of the primary methods cancers use to hide from the immune system. Blocking TGF-B allows the vaccine to initiate a strong immune response, resulting in long-term clinical benefit with minimal toxicity.
NovaRx is a private biotechnology company headquartered in San Diego. Using its TGF-B-blocking platform technology, NovaRx is also developing a universal tumor cell vaccine that targets all cancers and may be used therapeutically or prophylactically. www.novarx.com
This press release contains forward-looking statements that are subject to risks and uncertainties surrounding the safety and efficacy of Lucanix and the approval of a new drug by FDA and EMA.
SOURCE NovaRx Corporation
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