Seems like VLTS is reporting decent progress and not geting much credit for it these days.
>>Valentis Clinical Trial of a Novel Intravenous IL-2 Gene Medicine for Cancers In the Lung Is Underway
BURLINGAME, Calif., Apr 19, 2001 /PRNewswire via COMTEX/ -- Valentis, Inc. (Nasdaq: VLTS chart, msgs) announced today that it has dosed the first four patients in a Phase I clinical trial of its intravenously administered human Interleukin-2 (IL-2) gene medicine, VLTS-587. The goal of the trial is to determine the maximum tolerated dose of the IL-2 gene medicine in patients with cancers in the lung. By expressing the IL-2 gene locally in the lung, VLTS-587 is designed to deliver the IL2 protein to lung tumors while minimizing systemic exposure and associated adverse effects.
The clinical trial is being conducted by John Hainsworth, M.D., at the Sarah Cannon Cancer Center in Nashville, Tennessee and by Scott Antonia, M.D., at the H. Lee Moffitt Cancer Center in Tampa, Florida. Up to 36 patients will be enrolled in this multi-center clinical study, which is expected to run through 2001. Upon entry into lung cells, VLTS-587 is intended to lead to human IL2 protein expression in the pulmonary and tumor vasculature and local immune activation.
Peter Sayre, M.D., Ph.D., who heads Valentis' Clinical Oncology Development explained, "This trial represents a significant advance by our oncology team. The ability to deliver our gene medicines intravenously should allow us to treat far more patients than can be treated by injections directly into tumors. VLTS-587 is designed to provide an opportunity to focus and amplify an immune response against both primary lung tumors as well as cancers having pulmonary metastases for which chemotherapy has limited effectiveness. VLTS-587 is the first of our next generation oncology gene medicines."
Valentis' preclinical studies in several animal models including mouse, rabbit and non-human primates, verified the expression of human IL2 in the lung following the intravenous delivery of VLTS-587. Efficacy studies in mouse model systems, as well as in dogs with spontaneously occurring metastatic pulmonary neoplasms, indicated anti-tumor activity as evidenced by a significant reduction in tumor burden.
The systemic IL-2 gene medicine is the next generation of Valentis' cytokine-based gene medicines developed for cancer. The systemic IL-2 gene medicine uses an optimized synthetic cationic lipid-based gene delivery system that has been shown to efficiently localize in the lungs, and preferentially in pulmonary tumor lesions, enabling tumor localization via intravenous administration.<<
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Cheers, Tuck |
