IMMUNOVATIVE CLINICAL RESEARCH PASSES BASELINE 21 CFR 1271 AUDIT

Immunovative's wholly-owned subsidiary, Immunovative Clinical Research, Inc. (ICRI) in Phoenix, AZ announces that its blood donor screening, collection, testing , processing and shipping operations have passed a baseline independent audit as being in compliance with 21 CFR 1271 (GTP)regulations.  CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of biological products derived from blood.

The blood processing must be conducted in a way that prevents the introduction, transmission, or spread of communicable diseases from donor to patient.   The regulations cover the screening and testing of the blood donor. Regulations require that the blood collected must be drawn, processed, stored, labeled, packaged and shipped in a way that prevents the introduction, transmission, or spread of communicable diseases. ICRI collects whole blood from healthy donors and purifies white blood cells from the whole blood in a controlled aseptic environment.  The cells are shipped to Jerusalem for further processing into T-Stim intermediate product.  US FDA requires the company to use only product derived from 1271 compliant blood in US clinical trials.

SPECIALITY INFORMATION

patients


Treatment strategy designed to use the power of the human immune system to kill tumors and prevent their recurrence.
No requirement for a matched donor or chemotherapy/radiation conditioning prior to treatment.
Innovative technology – proven and non-toxic.
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Healthcare professionals


Therapeutic anti-tumor vaccine developed from core break-through technology called the "Mirror Effect™“ which opens a pathway to treating patients with metastatic cancer that have failed all available therapy options.
Elicits a GVT-like mechanism without the GVHD toxicity.
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Investors


Privately-held Israeli biopharmaceutical company spin out from Hadassah-Hebrew University Medical Center with headquarters in Jerusalem.

Over 200 individual private shareholders and grant support from the Israel Office of the Chief Scientist.
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