inCVAX is effective
Human pilot trials are in progress off-shore that are yielding very promising results with significant tumor shrinkage.
Each patient participating in these off-shore trials is individually evaluated for toxicity tolerance through physical exams and by appropriate supplemental and routine laboratory tests (CSC, UA and complete metabolic profile) before and during therapy. Observable tumors in patients are followed with physical examination and radiological evaluations. Treatment efficacy is judged by the size, number, and activity of local and systemic metastases before and after treatment when patients are restaged with PET/CT examinations. All patients are biopsied to ensure eradication of the disease. Secondary efficacy parameters include the values of the hematology and blood chemistry studies. Other immunological parameters are monitored that may reveal clues to the ultimate mechanism of action of this form of treatment.
Immunophotonics is currently preparing an Investigational New Drug (IND) application to submit to the FDA in order to begin US-based clinical trials.