The BioBalance Corp. a wholly owned subsidiary of New York Health Care released the results of an experimental study in which a formulation of its proprietary biotherapeutic agent Probactrix appeared to rapidly and effectively control diarrhea and other abdominal symptoms commonly associated with complications of radiation and chemotherapy.

Dr. Robert Hoerr, Director of Medical and Regulatory Affairs at BioBalance: noted that "Eight million Americans are treated annually for various types of cancer, with diarrhea being the most common side effect from chemo- or radiation therapy. The incidence of chemotherapy-induced diarrhea (CID) can be as high as 85%, depending on the chemotherapeutic agent, dosage or whether combination therapy is used."

Clinical trials were performed on 237 patients undergoing a standard course of chemotherapy, separately or in combination with radiotherapy. A control group of 115 patients were not treated with the Probactrix formulation.

Results of the hospital study showed that the product reduced gastrointestinal complaints in as early as two to three days after initiation of treatment. Within seven days of treatment, diarrhea symptoms were markedly reduced or totally disappeared in the treatment arm. In addition, appetite showed significant improvement along with positive quality-of-life measures such as general well being and overall physical condition of the patient. The product was well tolerated with no reported side effects.

While CID can be life threatening due to dehydration, it can also result in delays in treatment or require changing to less effective chemotherapy. Although available drugs such as loperamide are very effective in mild diarrhea, patients with CID can sometimes be refractory to loperamide, which is particularly problematic in children. Diarrhea is also a quality of life challenge for caregivers and children alike; it is also a major nutritional and health problem for these patients due to loss of fluids and reduced body mass.