Navigation Links
Cytopia's CYT387 Receives FDA Clearance to Start US Clinical Trials

MELBOURNE, Australia, Sept. 3 /PRNewswire/ -- 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.

"Approval of the company's second IND marks another milestone in the development of Cytopia's suite of small molecule drugs," said Mr. Andrew Macdonald, CEO. "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."

There has been considerable commercial interest in the JAK2 target with no selective JAK inhibitors having yet successfully completed late stage clinical trials and few compounds in development that meet a desirable product profile. Cytopia will seek to develop CYT387 through a commercial partnership and has been in discussions with potential partners for some time. A similar JAK2 inhibitor in clinical development was recently licensed by Onyx Pharmaceuticals for $550 million including a $25 million up-front payment and double-digit royalties.

About Cytopia

Cytopia Ltd is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer and other diseases. Cytopia conducts its research and drug development through subsidiaries based in Melbourne, Australia and California, USA and specializes in developing new small molecule compounds with an improved therapeutic profile for the treatment of cancer.

The company's lead drug candidate is CYT997, a vascular disrupting agent (VDA) for the treatment of various cancers, which is currently being trialled in Phase II clinical studies. Cytopia is continuing to build on its range of JAK inhibitors and kinase expertise, with CYT387, a novel oral JAK1/JAK2 inhibitor focused on the treatment of myeloproliferative disorders, to enter Phase I clinical studies in 2009.

SOURCE Cytopia Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Stemedica Achieves Major Milestone - Company Receives License to Manufacture Clinical Grade Stem Cells
2. Families of Spinal Muscular Atrophy Receives FDA Orphan Drug Designation For Quinazoline495 For The Treatment of Spinal Muscular Atrophy
3. Mennen Medical Receives Frost & Sullivan 2009 European Patient Monitoring Technology Leadership Award
4. WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD
5. Covance Receives Highest Level of Phase I Accreditation
6. Worlds First Cardiac Adult Stem Cell Patient Receives Infusion
7. Lexicons Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA
8. Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks
9. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
10. USC Keck School of Medicines Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic
11. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
Post Your Comments:
(Date:12/1/2015)... Dec. 1, 2015 Array BioPharma ... that its Chief Executive Officer, Ron ... Annual Healthcare Conference in New York.  The ... conference through a webcast on the Array ... , --> , ...
(Date:12/1/2015)... Dec. 1, 2015 Assurex Health, Inc. ... test giving healthcare providers an expanded range of ... patients suffering from depression, anxiety, bipolar disorder, posttraumatic ... conditions. i .   ... With the addition of two new drug classes, ...
(Date:12/1/2015)... 1, 2015 --> ... report "Nucleic Acid Labeling Market by Product (Reagents & ... Primer, In Vitro Transcription, Reverse Transcription, End Labeling), by ... The global market is expected to reach USD 1,925.7 ... growing at a CAGR of 8.65%. Browse ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 02, 2015 , ... ... events and association with initiation of treatment for osteoporosis ”. , As corresponding ... pharmacological treatment in patients diagnosed with osteoporosis. Based on a large US managed ...
(Date:12/1/2015)... ... December 01, 2015 , ... According to an article published ... discrimination claim against the U.S. Department of Health and Human Services, claiming that any ... plans are breaking the clause in the law prohibiting the denial of coverage for ...
(Date:12/1/2015)... ... December 01, 2015 , ... Dr. Paul Vitenas, one of ... has been named by MedEsthetics magazine as the Best Single Physician Practice in the ... the many elite aesthetic physicians honored by the industry publication. , Dr. Vitenas ...
(Date:12/1/2015)... NY (PRWEB) , ... December 01, 2015 , ... ... in the 1980s we have seen vast improvements in scientific research and discoveries, ... significant strides, providing increased hope and relief to those affected by HIV/AIDS. Mediaplanet’s ...
(Date:12/1/2015)... ... December 01, 2015 , ... Diabetic ... United States. Podiatrists are well aware that psychology-based patient non-compliance (disobedience of a ... catastrophic contributors to diseases of the diabetic foot. The American Board of ...
Breaking Medicine News(10 mins):