FDA

Vivolux Cancer Drug Receives FDA Clearance for Clinical Study

Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Researchers at Vivolux have discovered a novel cancer drug target within the proteasome in tumor cells. This novel drug candidate inhibits tumor growth and prolongs survival in multiple myeloma in preclinical models that are resistant to conventional therapies.

 The clinical study will be conducted in collaboration with the Memorial Sloan-Kettering Cancer Center and the Dana-Farber Cancer Institute at Harvard Medical School. This first study is designed to determine the safety and efficacy of VLX1570 in patients with multiple myeloma who are no longer benefiting from conventional cancer treatment.

 Inhibitors of the proteasome (e.g. bortezomib / Velcade) have been available for the treatment of malignant diseases (e.g. multiple myeloma and mantle cell lymphoma) for some years although lack of response and/or development of resistance (which almost invariably occurs) is a major clinical problem. The novel drug candidate VLX1570 acts on the proteasome through a new mechanism of action, by inhibiting the initiation process that regulates the breakdown of defective protein, the cancer cells are forced into apoptosis – programmed cell death. There is a significant medical need in multiple myeloma therapy, especially for patients who have become resistant to currently available cancer treatment such as bortezomib (Velcade).

 Preclinical research has generated considerable interest and results have been published in major scientific journals such as Nature Medicine and Blood. This is the second drug candidate developed by Vivolux to receive FDA clearance to proceed into the clinical phase.

 Date: October 7, 2014

Source: Vivolux

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