Cytopia Limited's (ASX: CYT) Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (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 United States.
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.
Hyperactivity of the JAK2 enzyme is known to cause a number of haematological conditions known as myeloproliferative disorders (MPDs). This group of diseases includes myelofibrosis, polycythemia vera and essential thrombocythemia. 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 trialled 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. Myelofibrosis is a life-threatening scarring of the bone marrow. This study will be undertaken at the Mayo Clinic in Rochester Minnesota under the chairmanship of Dr. Ayalew Tefferi, a key opinion leader in MPD treatment. The company anticipates opening the study to enrolment in the fourth quarter of 2009. Further details of the study will be disclosed following site ethics committee approval.