|What to watch at ASH 2010|
|By Patrick Crutcher|
|Friday, 03 December 2010 14:34|
The 52nd Annual Meeting of the American Society of Hematology (ASH) kicks off this weekend and with that in mind, we wanted to highlight some stocks that investors should watch going into this meeting. Many companies will be presenting new data from ongoing and completed trials.
This is the biggest gathering professionals concerned with the causes and treatments of blood disorders. The meeting runs from December 4th-7th in Orlando, Florida. Companies The all important oral sessions of the meeting will take place on Monday and Tuesday. Most importantly for investors, we get to see how pipeline candidates are progressing for companies. Let's make our way through some that we find interesting.
Cyclacel Pharmaceuticals (NASDAQ: CYCC) plans to present Phase 2 1-year survival data of sapacitabine in patients with myelodysplastic syndromes (MDS). CYCC hopes that sapacitabine will eventually be used as a 2nd-line treatment in MDS. There needs to be >50% survival rate at 1-year for sapacitabine to be meaningful in this disorder. At ASCO 2010, they reported interim data on the overall response rate with 24 ‐ 35%. Beyond ASH 2010, keep in mind CYCC is still awaiting top-line results from the APPRAISE NSCLC Phase 2b trial of seliciclib and interim Phase 2 data of sapacitabine in patients with NSCLC.
UPDATE: We contacted management about the survival rate and what we should be looking for. Cyclacel's Director of Corporate Finance, Corey Sohmer, had this to say,"As there is no approved drug for MDS refractory to hypomethylating agents (Vidaza, Dacogen are both approved for front line), there is no published benchmark for 1-year survival. The suggested 50% rate is very close to the presumed rate for front line MDS drugs.
The population of our Phase 2 study includes many patients who have failed both Vidaza and Dacogen. There are also several who have failed Revlimid in addition to one or both of the other two. In light of this heavily pretreated patient population, including double and triple refractory patients, we use a 20% or higher rate of 1-year survival to determine whether sapacitabine should be further developed in MDS refractory to hypomethylating agents." (Thanks, Nick DeCesare!)
Array BioPharma (NASDAQ:ARRY) will be presenting Phase 1 data on their KSP inhibitor, ARRY-520, in multiple myeloma. Management has commented that some patients have been receiving treatment for more than 12 months. This drug is garnering within the company and broader medical community. It is currently unpartnered. Notably, they have seen strong pre-clinical data when combining ARRY-520 with Velcade in MM patients. ARRY will be initiating a Phase 1b combination trial of 520 and Velcade in MM patients. They also recently got a $10M milestone payment from Celgene for preclinical work.
YM Biosciences(NASDAQ: YMI) will be presenting detailed results on their JAK 1/2 inhibitor, CYT387. CYT387 is currently being investigated in a Phase I/II clinical study at Mayo Clinic in patients with myelofibrosis. YM Biosciences has already published some data from this presentation, which showed good clinical improvements in anemia rates, spleen size reduction and other symptoms. They recently filed a $115M shelf, so keep that in mind.
Seattle Genetics (NASDAQ: SGEN) is certainly a company investors should be watching thru ASH 2010. SGEN will be giving 2 oral presentations on brentuximab vedotin (SGN-35), providing more complete data from a pivotal trial in relapsed or refractory Hodgkin lymphoma(HL) and a Phase 2 trial in relapsed or refractory anaplastic large cell lymphoma(ALCL). Extremely positive top-line data from both trials were reported in late September. SGEN is hopeful to submit a BLA including both Hodgkin lymphoma and ALCL indications in the first half of 2011. See our recent report on them. (Link below)
ASH 2010 Home page - http://www.hematology.org/Meetings/Annual-Meeting/
ASH 2010 Abstracts - http://ash.confex.com/ash/2010/webprogram/start.html
Novartis PR on ASH 2010 - http://bit.ly/g243qs
YMI to present on CYT387- http://yhoo.it/9U6Jy3
AEZS/KERX to present on perifosine - http://yhoo.it/h1SSHC
CYCC to present on sapacitabine in MDS - http://yhoo.it/gIEC7nARRY to present on ARRY-520 - http://yhoo.it/dVJGHV