What to watch at ASH 2010 Print E-mail
By Patrick Crutcher   
Friday, 03 December 2010 14:34

ASH-logo 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!)

Aeterna Zentaris (NASDAQ:AEZS) and Keryx Biopharmaceuticals (NASDAQ: KERX) have multiple abstracts for data concerning KRX-0401 (perifosine). They are currently running a Phase 3 program in multiple myeloma and advanced metastatic colorectal cancer, which is being conducted under an SPA.  We shouldn't forget that they are also testing perifosine in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and several others. Some of this data will be at ASH along with data about combination therapies with perifosine. Holding AEZS over the next few months could be idea, especially if perifosine delivers.

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)

For those more interested in big pharma, there is still something to be excited about. Norvartis (NASDAQ: NVS) has nearly 170 abstracts accepted, so you can expect to hear a lot about what's happening in their hematology division. Specifically, we're interested in the 24-month update on Phase III data comparing Tasigna® to Gleevec® in patients with newly diagnosed Ph+ chronic myeloid leukemia(CML) in chronic phase. Additionally, companies like Roche and Pfizer have important presentations regarding Rituximab and Crizotinib.

No matter what your preference, there are companies publishing data over the next few days that could have an appreciative effect on their value. We will keep you updated over the next week as the results from these presentations make their way to the public.

Disclosure: Long AEZS, ARRY, CYCC

ASH 2010 Home page - http://www.hematology.org/Meetings/Annual-Meeting/

ASH 2010 Abstracts - http://ash.confex.com/ash/2010/webprogram/start.html

Our report on SGEN - http://biomedreports.com/2010112360507/strong-immunotherapy-company-going-into-2011.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/gIEC7n

ARRY to present on ARRY-520 - http://yhoo.it/dVJGHV



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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