SBIR-STTR Award

The purpose of this study is to conduct a Phase II clinical trial in patients with incurable non-small cell lung cancer (NSCLC). Our aim is to induce antitumor immune responses by immunizing patients with an experimental vaccine comprised of four allogeneic NSCLC cell lines genetically modified with a TGFbeta 2 antisense vector. By blocking secretion of the immunosuppressive molecule TGF-beta in this manner we inhibit one of the major mechanisms by which tumor cells evade immune surveillance. Developing an effective therapy for the disease that accounts for 30 percent of all cancer-related deaths will benefit the approximately 180,000 new patients that develop lung cancer in the United States each year. In a previous clinical trial, we have shown that injections with gene-modified allogeneic tumor cells induced cellular immune responses to autologous tumor cells. In this trial, 18 patients will be randomized into three cohorts that will receive 1.25 x 10exp7, 2.5 x 10exp7, or 5 x 10exp7 TGF-beta antisensemodified vaccine cells. Following completion of this phase of the trial, an additional 48 patients will be enrolled in the two cohorts that demonstrate the best clinical responses. We anticipate that our treatment will induce measurable clinical responses in some of the treated patients. PROPOSED COMMERCIAL APPLICATIONS: The potential patient pool for this study is 180,000 patients annually in the United States. When considering other parts of the world, the potential patient pool is significantly larger. Once the Phase II clinical trial is completed, and the efficacy of our method is proved, we will perform the subsequent phases of our clinical trial phases, as well as the commercialization of our method in partnership with a pharmaceutical company that has the facility to mass produce and market our vaccine.

Thesaurus Terms:
antisense nucleic acid, human therapy evaluation, lung neoplasm, neoplasm /cancer vaccine, transforming growth factor active immunization, cellular immunity, clinical trial phase II /III /IV, nonsmall cell lung cancer, vaccine development clinical research, human subject, patient oriented research

The purpose of this study is to conduct a Phase II clinical trial in patients with incurable non-small cell lung cancer (NSCLC). Our aim is to induce antitumor immune responses by immunizing patients with an experimental vaccine comprised of four allogeneic NSCLC cell lines genetically modified with a TGFbeta 2 antisense vector. By blocking secretion of the immunosuppressive molecule TGF-beta in this manner we inhibit one of the major mechanisms by which tumor cells evade immune surveillance. Developing an effective therapy for the disease that accounts for 30 percent of all cancer-related deaths will benefit the approximately 180,000 new patients that develop lung cancer in the United States each year. In a previous clinical trial, we have shown that injections with gene-modified allogeneic tumor cells induced cellular immune responses to autologous tumor cells. In this trial, 18 patients will be randomized into three cohorts that will receive 1.25 x 10exp7, 2.5 x 10exp7, or 5 x 10exp7 TGF-beta antisensemodified vaccine cells. Following completion of this phase of the trial, an additional 48 patients will be enrolled in the two cohorts that demonstrate the best clinical responses. We anticipate that our treatment will induce measurable clinical responses in some of the treated patients. PROPOSED COMMERCIAL APPLICATIONS: The potential patient pool for this study is 180,000 patients annually in the United States. When considering other parts of the world, the potential patient pool is significantly larger. Once the Phase II clinical trial is completed, and the efficacy of our method is proved, we will perform the subsequent phases of our clinical trial phases, as well as the commercialization of our method in partnership with a pharmaceutical company that has the facility to mass produce and market our vaccine.

Thesaurus Terms:
antisense nucleic acid, human therapy evaluation, lung neoplasm, neoplasm /cancer vaccine, transforming growth factor active immunization, cellular immunity, nonsmall cell lung cancer, vaccine development clinical research, human subject, patient oriented research