Date: 2016-05-16
Type of information: Treatment of the first patient
phase: 2-3
Announcement: treatment of the first patient
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: Mexico, USA
Trial
details: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate 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 been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. 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 of care active surveillance evaluations. (NCT02768363)
Latest
news: * On May 16, 2016, Advantagene announced that it has treated the first patient in the ULYSSES study, a Phase 2b “Proactive Surveillance™” trial of its novel immuno-oncology product, ProstAtak®, in patients with localized prostate cancer choosing active surveillance. ProstAtak® is the trade name for the company’s Gene Mediated Cytotoxic Immunotherapy (GMCI™) used in patients with prostate cancer. This multinational study is being conducted in the United States and in Mexico with collaborators Cellpharma, a regional pharmaceutical company, and the National Institute of Medical Sciences and Nutrition, Mexico.
The ULYSSES study is a multicenter, randomized, double blind, placebo-controlled study in prostate cancer patients choosing active surveillance. The study is designed to assess the efficacy of ProstAtak® compared to placebo and aims to enroll 156 patients. Eligible patients will be randomly assigned in a 2 to 1 ratio to the test arm or the control arm. The primary endpoint for the study is the percentage of patients with improvement in a composite active surveillance score based on prognostic tumor markers twelve months after treatment. The study will also evaluate multiple secondary endpoints to help better understand the immune response.
