Date: 2011-05-19
Type of information: Clinical trial authorization
phase: 3
Announcement: clinical trial authorization
Company: Advantagene (USA - MA)
Product: ProstAtak®( aglatimagene besadenovec)
Action
mechanism: immunotherapy product/gene therapy. ProstAtak™ is designed as an “off-the-shelf” drug to kill tumor cells and stimulate a vaccine effect against the patient’s specific tumor, in essence activating the patient’s own immune system to prevent tumor recurrence. The product is based on Gene Mediated Cytotoxic Immunotherapy™ (GMCI). Upon administration, GMCI will generate a precise and robust patient specific immune response, attacking a patient’s solid tumors, distant metastases, or minimum residual disease. The technology consists of a series of small gauge, relatively painless injections at the tumor site or target tissue followed by the oral administration of an activating prodrug. The initial injections deliver aglatimagene besadenovec (AdV-tk), a gene vector derived from an adenovirus and engineered to deliver the thymidine kinase (tk) gene, derived from the Herpes Simplex virus, to the target cells. The target tissues and cells then produce the TK protein. Cells that multiply in the neighborhood of where the TK protein was delivered and is now expressed then become susceptible to the toxic effects of valacyclivir. Administration of valacyclivir then causes a cytotoxic biochemical reaction at the site of administration that leads to the death of multiplying tumor cells, cells repairing themselves from radiation or chemotherapy damage, and endothelial cells from growing tumor vessels. A subsequent cascade of immuno-stimulatory events, including the production and recruitment of disease fighting cytokines and cancer killing T-Cells, amplified by TK’s “super-antigen” characteristics, stimulates the in situ development of a precise, patient-specific anti-tumor immune effect to combat cancer cells. As a result, massive amounts of newly created T-cells, primary weapons used by the body to fight cancer, now recognize cells expressing a patient’s unique TAAs. These T-cells will identify, attack and destroy cancer cells expressing these antigens both at the site of the tumor and anywhere else in the body. Some of these new T-cells, called memory T-cells, can remain for years, patrolling the body for remaining cancer cells and providing a durable “vaccine like” effect, resulting in the eradication of tumors in some cases or slowing their growth or spread in others.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak® can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required. (NCT01436968)
Latest
news: * On May 19, 2011, Advantagene announced that it reached an agreement with the FDA on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer. The trial is expected to accrue 711 patients starting mid-2011 with definitive results expected by 2015. The randomized study will evaluate ProstAtak’s ability to prevent prostate cancer recurrence. If successful, it could yield the first drug product for newly diagnosed, localized prostate cancer. Protocol development was co-chaired by Drs. Theodore DeWeese, Chair of Radiation Oncology at Johns Hopkins and Peter Scardino, Chief of Surgery and Chair of Urology at Memorial Sloan Kettering Cancer Center.
