Sydney, Australia, 17 June 2011; Australian monoclonal antibody company, Immune System Therapeutics Limited (IST), today announced it would double patient recruitment in its Phase II trial for a breakthrough antibody treatment for terminal blood cancer.
The trial expansion in Australia follows a positive review of safety and efficacy data by an independent Data Monitoring Committee (DMC) of data from the first six patients treated with the new monoclonal antibody therapy at The Alfred Hospital in Melbourne under the supervision of principal investigator and head of Malignant Haematology and Stem Cell Transplantation, Professor Andrew Spencer.
The DMC recommended that recruitment under the trial be expanded to include up to 27 patients suffering from the life threatening disease multiple myeloma.
The promising new drug, called MDX-1097, is a genetically engineered antibody that binds specifically to a target protein found on the cell surface of some types of blood cancer. Researchers anticipate the antibody will potentially reduce the number of cancerous cells in multiple myeloma patients and improve patient health and wellbeing. Laboratory studies have shown that the antibody works with the patient's immune system to induce death of their multiple myeloma cancer cells.
IST Chief Executive Officer, Mr Alan Liddle, said, "We are very excited to have achieved this important milestone towards our goal of developing an effective treatment for patients suffering from this debilitating blood cancer. We intend to initiate another hospital site in Australia to accelerate recruitment as soon as possible."
"Simultaneously we are putting in place the appropriate licensing structure to enable the further clinical development and regulatory processes needed to commercialise this promising new medical treatment. We are in discussion with a number of global pharmaceutical companies," Mr Liddle added.
IST Head of Clinical Development, Dr Rosanne Dunn, said "One patient has shown a very good decrease in blood levels of both of the abnormal or "monoclonal" proteins produced by the myeloma cells. No adverse effects or drug related side effects have been observed in any patients as the antibody only targets and kills the kappa myeloma cells and doesn't bind to any normal cells or tissue.
"The response we are seeing is rare in cancer treatment and an indication that the antibody specifically targets cancer cells and not normal cells. Our current Phase II trial builds on the results of the Phase I trial in 12 patients at The Alfred hospital which showed the drug was safe and well tolerated and no drug related toxicities were observed," Dr Dunn said.
Multiple myeloma is a debilitating terminal disease, with an estimated patient population of over 150,000 worldwide. The disease typically occurs in older patients and is responsible for two per cent of all cancer deaths in the United States every year.
IST is undertaking additional preclinical work using the same antibody platform technology to target other diseases with major unmet clinical needs.