Ohr Pharmaceutical has reported results from its OHR/AVR118 Phase II trial conducted in cancer patients with cachexia.
Cachexia, which is a multi-symptom syndrome found in late-stage cancer patients, is characterised by loss of appetite, weight loss, tissue wasting and skeletal muscle atrophy, and has no FDA-approved treatment.
At the completion of treatment protocol in the open-label study, patients achieved stabilisation of body weight, body fat and muscle mass with a significant increase in appetite (p=.001).
Ohr Pharmaceutical CEO Dr Irach Taraporewala said OHR/AVR118 is a potent therapeutic against debilitating effects of cachexia in cancer patients.
"Stronger, more stable patients have a much better chance of tolerating the intense chemotherapies and radiation therapies involved in treating late stages of cancer," Taraporewala said.
"The drug treatment demonstrated improved QOL in the patients and stabilisation of body weights and their functional abilities even on prolonged administration, preventing the rapid decline in these parameters often seen in such cachectic patients with advanced neoplasms."
Although the primary trial endpoint of weight gain was not reached, an enhanced quality of life was demonstrated as Patient Generated Subjective Global Assessment (PG-SGA) scores showed improvement.
Statistically significant differences from baseline (as indicated by the paired t test) in body fat content, arm circumference, triceps fold measurement, nausea or vomiting were not observed.
Patients with stage III or IV solid tumours were enrolled and were administered with daily subcutaneous injections of OHR/AVR118 for the treatment period of 28 days.
The broad-spectrum peptide immunomodulator drug was well-tolerated in the study.
Ohr chairman Ira Greestein said; "We believe that we have reached a value inflection point with the OHR/AVR118 programme and will begin to evaluate strategic options to provide value from the programme to our shareholders and further the clinical development of this important drug."