New Drug In Multiple Myeloma In Phase 1 Clinical Trial

IMMUNE SYSTEM THERAPEUTICS LTD MEDIA RELEASE

FOR IMMEDIATE RELEASE
3rd November 2008: SYDNEY, AUSTRALIA

Australian Biotechnology Company Commences

Phase 1 Clinical Trial of New Drug in Multiple Myeloma

Australian biotechnology company Immune System Therapeutics Limited ["IST" or the "Company"] announced today that a Phase I clinical trial of its monoclonal antibody therapy (MDX-1097) in multiple myeloma has commenced, and that enrolment and dosing of the first cohort of patients has been completed. Progress to the next patient cohort (which entails escalating the antibody dose being given to patients) was recently approved by the Human Research Ethics committee at The Alfred Hospital in Melbourne, Australia, where the trial is being conducted under the direction and supervision of Principal Investigator Associate Professor Andrew Spencer, Head of Malignant Haematology and Stem Cell Transplant Service at The Alfred.

This clinical trial represents the next important phase of development of this monoclonal antibody, which began at the University of Technology, Sydney ["UTS"] and has been taken through preclinical development by the scientific team at IST. Founding scientist Professor Robert Raison in whose laboratory the antibody was initially developed said "This is a very exciting next step for a significant piece of Australian science that has taken over 20 years to develop. The combined efforts of a number of people including fellow scientists, dedicated postgraduate students and those who have invested in the Company have resulted in the antibody taking a major step closer to being able to assist patients who are affected by this dreadful terminal disease."

Pre clinical studies demonstrate that the antibody has a unique mode of action in binding to a very specific antigen which is expressed on kappa myeloma cells. This unique character is protected by patents which have been issued to IST in the United States, Europe, Australia and New Zealand. Studies in the laboratory have indicated that the antibody is very specific for its target antigen and works with the human immune system to induce myeloma cell death.

Director of Clinical Development of IST Dr Rosanne Dunn said "We are very proud of this significant achievement of taking an antibody through drug discovery and pre-clinical development phase into the clinic to treat myeloma patients. This is a good example of how translational medicine works and is no small feat for a biotechnology company in Australia or anywhere."

The ongoing Phase I trial is an escalating dose study in up to 15 patients. The trial is designed to determine the safety and tolerability profile of MDX-1097 and is expected to be completed in June 2009. Pending the results from the Phase 1 trial, the Company may expand the program to a Phase Ib trial to explore the antibody's effectiveness against kappa type myeloma.

Mark Compton CEO of IST said "All of the team associated with the development of this lead candidate antibody in myeloma are very excited by its prospects. At IST, we have an exceptionally talented group of people working on the development of this antibody as well as on other new candidate antibodies and target diseases in our research pipeline. In addition we are pleased with the supportive and development efforts from our partnership with Medarex, Inc. (NASDAQ: MEDX)."

Mr Joe Collins, Chairman of IST said "IST is a grateful recipient of financial grants from the Australian Government [under the now discontinued Commercial Ready Grant program] and NSW State Government, which have allowed for critical work to be undertaken as part of the development of MDX-1097."

About "Multiple Myeloma"

Multiple myeloma is a terminal blood cancer that affects in excess of 100,000 patients in developed countries worldwide. It is a cancer of plasma cells, the white cells in the blood that produce antibodies. In multiple myeloma, malignant plasma cells multiply and accumulate in the bone marrow, crowding out the development of healthy cells, leading to anaemia and a weakened immune system. This results in recurrent infections, kidney failure, bone weakness and fractures.

Multiple myeloma is currently incurable despite the use of chemotherapy, radiotherapy and other treatments. At present, the average term for survival from initial diagnosis of multiple myeloma is approximately three years and the average five-year survival rate of those patients who have undergone existing therapies is approximately 12 percent.

Multiple myeloma comprises approximately one per cent of all cancers, but accounts for approximately two per cent of cancer-caused deaths. There are two types of multiple myeloma.
*kappa type (approximately 70 percent of patients)
*lambda type (approximately 30 percent of patients)

IST is developing drugs for the treatment of both types. Its therapy for kappa-type multiple myeloma "MDX-1097" is currently in Phase 1 clinical testing. Its treatment of the less common lambda-type multiple myeloma is at the early pre-clinical phase.

About IST

IST is an Australian company established in 2001, specialising in the development of monoclonal antibody [Mab] therapies for multiple myeloma and other blood cancers. The company was co-founded by scientists from the University of Technology, Sydney [UTS] who now form the core of the company's drug development team. IST has considerable expertise in the genetic engineering of monoclonal antibodies based on more than ten years of research conducted at UTS.

IST's lead antibody therapy is designed to target specifically and kill multiple myeloma cells. It does not target healthy cells, which may reduce the likelihood for side effects. If successful, it may have significant advantages over existing cancer treatments, resulting in extended and improved quality of life for sufferers.

IST has a strong management team, with a proven track record of commercialising technology, and a talented drug development group that has significantly advanced the development of its lead therapeutic.

Using the knowledge and experience gained in developing MDX-1097, IST's drug development team has commenced early stage evaluation of the effect of its Mabs on other blood cancers including some forms of lymphoma and Waldenstrom's macroglobulinaemia.

If you would like more information on IST and its activities please go to their website at www.istl.com.au.

Media enquiries
Please contact IST for any media enquiries on
(02) 9514 7437 or
via email to
[email protected].


SOURCE: Immune System Therapeutics Limited