Cytopia Receives FDA Clearance To Initiate US Clinical Trials For CYT387

Cytopia’s Investigational New Drug Application (IND) for CYT387 has passed the FDA review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders. The company’s IND application is now active and Cytopia is able to proceed with clinical trials for CYT387 in the US.

CYT387 will be the second of Cytopia’s compounds to enter clinical trials. The company’s anti-cancer vascular-disrupting agent CYT997 is already in phase II studies in Australia.

In addition, Cytopia has identified potential activity of CYT387 in a range of cancers which may substantially enlarge the value of this compound.

Dual JAK1/JAK2 inhibition is likely to increase the clinical benefit in these disease indications and broaden the therapeutic opportunities for CYT387. JAK kinase inhibitors with similar profiles are also being trialed in inflammatory diseases such as rheumatoid arthritis. CYT387 possesses optimized JAK1/JAK2 inhibition while minimising unwanted activity seen with other JAK2 inhibitors in clinical development.

Preparations for the company’s initial phase I/II trial of CYT387 in patients with myelofibrosis are currently being finalized. The company anticipates opening of the study enrolment in the fourth quarter of 2009.

Andrew Macdonald, CEO of Cytopia, said: Approval of the company’s second IND marks another milestone in the development of Cytopia’s suite of small molecule drugs. With a strong package of preclinical data, the prospects for CYT387 are excellent and we look forward to commencing the clinical trial with Dr. Tefferi at the Mayo Clinic later this year.