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Omacetax ine mepesuccinate (formerly known as Ceflatonin®, homoharringtonine or HHT), an investigational small molecule agent, is in Registration-Directed clinical trials to evaluate its safety and potential efficacy for the treatment of chronic myelogenous leukemia (CML) patients with the T315I point mutation who are resistant to Gleevec®. Omacetaxine is also in Phase 2 clinical trials in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Omacetaxine induces the death of cancerous cells through the process of apoptosis, or programmed cell death. This drug has demonstrated promising clinical activity in CML patients who have developed resistance to Gleevec® (imatinib mesylate) and other tyrosine kinase inhibitors, and may offer new options for the increasing number of CML patients who are developing resistance to tyrosine kinase inhibitors. 

Quinamed® (amonafide dihydrochloride), is in a Phase 2 trial for the treatment of hormone refractory prostate cancer. In a Phase 1 study to determine the best dose based on a patient's genotype, Quinamed® generated responses in patients with refractory prostate, ovarian and gastric tumors. In Phase 2, patients are genotyped prior to therapy to determine how quickly they metabolize the drug and are then assigned a specific dose based on their metabolic profile, or genotype. The goal is to maximize Quinamed®'s therapeutic potential while minimizing drug side-effects. 

Cash Position: The company had cash of $17,655,431 at 30 June 2009

Upcoming Events:
 - The completion of a rolling submission to the U.S. Food and Drug Administration (FDA) of an NDA for omacetaxine

 - The completion of a submission to the European Medicines Agency (EMEA) of an MAA for omacetaxine

Possible Competition & Similar Companies:
 - Epicept in Phase II for AML
 - Vion Phase III for AML

Some Key people in the company:
Dr George Morstyn MBBS BMedSci MAICD PhD FRACP (Non-executive Director). Dr. Morstyn has substantial clinical, research and commercial experience in biotechnology and oncology. He was Senior Vice President of Development and Chief Medical Officer at Amgen Inc from 1991 to 2002 (the world's largest Biotech company based in California). He has been a Director of a number of other high profile Australian biotechnology companies and chairman of the Board of GBS Ventures (a Venture capital firm).