FDA grants clearance to proceed with clinical study – new drug candidate from Vivolux could overcome drug resistance
Vivolux, a pharmaceutical company specialized in cancer treatment, announced today that the FDA has granted clearance to proceed with VLX1570 to clinical phase I/II 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.
Hans Rosén, CEO and founder, stated that the FDA decision to grant clearance for VLX1570 to proceed to the clinical phase is a new milestone for Vivolux. "The fact that this research has attracted interest at leading cancer institutions in the USA is solid recognition of the quality for our scientists and their work. There is a considerable medical need for new cancer drugs. VLX1570 represents a first-in-class molecule within a new mechanism of action acting on a proven druggable target, the proteasome. This is a promising cancer treatment. Vivolux has a strong project pipeline and we plan to submit new applications to the FDA during 2015."
Ola Landgren, MD, PhD, Chief Attending Physician of the Myeloma Service at Memorial Sloan-Kettering Cancer Center in New York, said: "VLX1570 is the first drug in a novel class of proteasome-inhibiting drugs and with promising preclinical data. We are excited to take it from bench to bedside".
Vivolux was founded in Sweden in 2004. The Swedish office is located at the AZ BioVentureHub in Gothenburg. Vivolux focuses on the development of novel cancer drugs based on phenotypic models, where the unique behavior of malignant cells under specific conditions is utilized to identify new targets and molecules acting on these targets. Working in close collaboration with research groups at Uppsala University and the Karolinska Institute, Vivolux has developed a unique and comprehensive system for preclinical analysis of cancer drugs, including tests on primary cultures of human cancer cells, cells grown in three-dimensional aggregates and methods for molecular investigation of mechanism of action. Several drug candidates have been identified and optimized and the results from these investigations have been published in international scientific journals. Two novel drugs with new mechanisms of action for cancer treatment are about to enter clinical investigation in collaboration with leading cancer institutions in the USA. Since 2014, the Vivolux head office has been located in Ashburn, Virginia, USA.
For further information, please contact:
Hans Rosén, CEO, hans.rosen@vivolux.com, phone: +1 202 400 1470
Stig Linder, stig.linder@ki.se, Professor of Experimental Oncology, Department of Oncology and Pathology, Karolinska Institute, phone: +46 (0)704 841275
Vivolux Inc: 20130 Lakeview Center Plaza, Suite 400, Ashburn, VA 20147, USA
Phone: +1 703-840-5474
Vivolux AB: AZ BioVentureHub SE-431 83 Mölndal, Sweden,
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