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Therapeutics Solutions International subsidiary Emvolio filed an Investigational New Drug (IND) application for use of its StemVacs cancer immunotherapeutic in patients with solid tumors.
Therapeutics Solutions International (OTCPINK:TSOI) subsidiary Emvolio filed an Investigational New Drug (IND) application for use of its StemVacs cancer immunotherapeutic in patients with solid tumors.
As quoted in the press release:
The trial seeks to establish safety and immune response of the cancer, targeting a new personalized dendritic cell vaccine.
“Completion of preclinical studies and submission to the FDA to initiate clinical trials is a major milestone for Emvolio. We are excited about the prospects of eventually adding this new weapon in the fight against cancer to the armamentarium available to oncologists,” said Timothy Dixon, Chairman of Emvolio. “The fact that StemVacs utilizes cells derived from the patient being treated, we believe this will provide a personalized element to this immunotherapy, which we anticipate will increase the possibility of an effective outcome.”
StemVacs is generated using dendritic cell progenitors isolated from patients, which are activated by a proprietary process which has previously been demonstrated to endow dendritic cells with the ability to produce “natural cytokines”, which kill cancer cells.
“It is a pleasure to work with the team at Emvolio on clinical translation of this exciting immunotherapeutic approach to cancer,” said Boris Reznik, Chairman and CEO of Biorasi, Inc. “As a Contract Research Organization (CRO) that loves to assist promising companies operating in the area of the Cutting Edge of Medicine, we are pleased that our collaboration has culminated into this regulatory filing.”
Biorasi is a customer-focused Contract Research Organization (CRO) that optimizes the design and delivery of clinical trials for its sponsors. Pharmaceutical companies around the globe have come to depend on Biorasi to consistently deliver success in clinical-phase development programs. Biorasi’s expertise includes a wide range of molecule types, therapeutic areas, and regulatory pathways.
