Conventional chemotherapy is notorious for its side effects. Common drugs of cancer chemotherapy attack rapidly dividing cells. These include tumor cells, but also
several types of normal, healthy cells such as bone marrow cells and the cells lining the intestine. For example, when the cells lining saliva glands, intestines and rectum are damaged, the patient may experience inflammation of the lining of the mouth and intestines, diarrhea, nausea and vomiting. Damage to cells in the bone marrow may cause a decrease in the number of white and red blood cells and platelets, resulting in increased risk of infection, anemia and bleeding. Damage to the cells of hair follicles results in hair loss, which is often difficult for patients to cope with. Last but not least, damage to cells in the reproductive system may result in temporary or permanent loss of fertility and the risk of fetal malformations.
Although these side effects are, for the most part, temporary, they are a source of major discomfort that may further aggravate the patient's already fragile state.
As opposed to conventional chemotherapy, our anti-angiogenic therapy has no major side effects. In preclinical studies in rats and dogs we observed no significant toxicity. Blood tests following treatment with our anti-angiogenic drug combination revealed no significant biochemical changes, nor irreversible changes in hematology indices. Tissue examinations in treated rats and dogs showed no systemic changes, and in particular, no signs of toxicity in the gastro-intestinal system, in the kidney or in other organs.
Our early drug-combination products have been tested for the past 2 years in a Phase I/II clinical trial. The most common adverse events reported were tolerable fatigue, gastrointestinal discomfort (e.g. nausea, vomiting, and diarrhea) and laboratory abnormalities, which were not accompanied by clinical symptoms. The few clinically significant severe adverse events encountered were resolved by dosing adjustments and/or common medical treatment.
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