from lifesciadvisors.com report.At the American Society of...

from lifesciadvisors.com report.


At the American Society of Hematology Meeting (ASH), ChemGenex presented new analysis of clinical data from all chronic phase (CP) chronic myeloid leukemia (CML) patients treated with OMAPRO in the CML-202 (T315I mutation) and CML-203 (resistant or intolerant to ?? 2 TKIs) Phase II (pivotal) studies.

Abstract 2290. ChemGenex poster entitled, ??Subcutaneous Omacetaxine (OM) Treatment of Chronic Phase (CP) Chronic Myeloid Leukemia (CML) Patients Following Multiple Tyrosine Kinase Inhibitor (TKI) Failure,?? was presented at ASH on Sunday evening. This poster combines data from both the ??evaluable?? (n=61) and ITT (n=85)chronic phase CML patients from ChemGenex two on-going open-label Phase II studies. As a reminder, over half of CML patients enrolled in the CML-202 and CML-203 where chronic phase patients, with the balance split between accelerated and blast phase patients (see our Initiation Report, available via download at www.lifesciadvisors.com). Evaluable patients are defined as those patients who 1) had been adjudicated by an independent Data Monitoring Committee (DMC), and 2) had a bone marrow report available for cytogenetic assessment.

The Pivotal Studies. As a reminder, Study CML-202 enrolled patients with imatinib-resistant CML who had the T315I mutation and Study CML-203 enrolled patients who were resistant or intolerant to ?? 2 TKI. These studies will form the basis a new NDA combining data from both for the treatment of CML patients who have failed two or more TKIs independent of their mutation status. While these trials have completed enrolling, data collection is ongoing. This new NDA is expected to be filed in 2H11.

Poster Data. Of the 85 CP-CML patients analyzed in this poster, 48 (56%) had 2 prior TKIs and 37 (44%) had 3 prior TKIs. The median duration of study participation was 8.3 months and the median number of cycles administered was 5.
We have summarized the results of the analysis for the combined 2 and 3 prior TKI experienced patients in

Figure 1. We believe these results bode well for approval of this NDA given the lack of therapeutic options for this population.







Safety. The safety profile for OMAPRO is as has been reported previously. The most common treatment-emergent adverse events are hematological in nature. Grade 3/4 hematological adverse events (>5%) were thrombocytopenia 54/85 (64%), anemia 29/85 (34%), neutropenia 40/85 (47%), febrile neutropenia 12/85 (14%), leukopenia 18/85 (21%), lymphopenia 15/85 (18%), pancytopenia 8/85 (9%), and bone marrow failure 9/85 (11%).

Our Observations. In addition to representatives from Cephalon, we note an increased interest in the ChemGenex poster over what we saw at ASCO, for example, from representatives from other pharma companies in the space. While Cephalon does have the option to increase their position in ChemGenex to 19.9% come March 31st, the current relationship does not preclude another pharma from entering the picture.

Upcoming Milestones

YE 2010: Shareholder vote to allow Cephalon to exceed 20% ownership
March 31, 2011: Exercise of Cephalon?? option to acquire additional 19.9%.
1H 2011: Possible approval for OMAPRO in T315I patients in Europe
2H 2011: New ??Third-line?? NDA expected to be filed for OMAPRO
1H 2012: Expected FDA approval of OMAPRO (Priority Review) and possible panel