"We are excited with the promise MDX-1097 has demonstrated to date in patients with multiple myeloma, and pleased that industry experts have recognized the potential of this new drug candidate to attract partners to accelerate its development," said IST Chief Executive Officer Dr Calum McKinlay.
“We welcome further validation of the potential of our proprietary technology to provide novel therapies for cancers with critical, unmet clinical needs,” he added.
In June 2011, MDX-1097 received orphan drug designation from US health regulators, giving the company and its potential licensing partners help with the regulatory approval process and marketing exclusivity in the US for a number of years. IST also recently announced the expansion of its Phase IIa clinical trial in Australia following encouraging responses from the first dosed patients and positive safety data.
IST is commercialising a range of new drugs to treat human blood cancers and autoimmune diseases. Its lead compound, MDX-1097, is a genetically engineered antibody that binds to a target protein found on the cell surface of some types of blood cancer and has the potential to reduce the number of cancerous cells in multiple myeloma patients. IST recently doubled patient recruitment in its Phase IIa trial after a positive review of safety and efficacy data by an independent Data Monitoring Committee of results from the first six patients.
The US Food & Drug Administration (FDA) granted MDX-1097 orphan drug designation in June 2011. Orphan drug status is given to drugs used to treat diseases which there is no existing treatment and where there are less than 200,000 patients in the US. This means more rapid progress through regulatory hurdles and provides market exclusivity in the multi-billion dollar myeloma treatment market for seven years--independent of any patent the drug may hold.
The company expects to secure a licensing partner and complete Phase IIa clinical trials within the next year.
For more information please contact:
Dr Calum McKinlay
Chief Executive Officer
Tel: (02) 9514 7434 or 0428 291 464
About Windhover
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About Immune Systems Therapeutics
Immune Systems Therapeutics (IST) is a private bio-therapeutic company commercialising a range of promising new antibody drugs to treat human blood cancers and autoimmune diseases. The company’s unique therapies target a range of common blood cancers known as B cell malignancies and autoimmune diseases. IST has extensive and robust patents covering a new class of drugs targeting blood cancers and autoimmune diseases that are potentially safer, less toxic and more effective than current standard chemotherapy treatments. IST’s business plan is to license its drugs to international pharmaceutical companies for regulatory approval, production and sales. For more information please visit www.istl.com.au
