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ORR in Sunesis Pharma's (SNSS) Vosaroxin + Decitabine Phase III Improves; Roth Affirms 'Buy' Rating

June 3, 2014 9:42 AM EDT
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Price: $5.32 --0%

Rating Summary:
    5 Buy, 6 Hold, 2 Sell

Rating Trend: = Flat

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Roth Capital has Sunesis Pharmaceuticals (Nasdaq: SNSS) with a Buy rating and target price of $15 following an ASCO presentation of ongoing data from MD Anderson Phase I/II study of vosaroxin + decitabine in elderly AML and high-risk MDS.

Analyst Joseph Pantginis comentted, Recall that at AACR in April, M.D. Anderson presented encouraging data from this study combining vosaroxin and decitabine (Dacogen) in older AML patients with no prior treatment. An overall response rate (ORR) of 67% (24 evaluable patients) was seen. Now with 30 evaluable patients, the high ORR has been improved to 73%. In addition, 13 patients (43%) have achieved CR. We see these high response rates as very encouraging in this population that is not eligible for chemotherapy. We are also encouraged that these responses were seen in a variety of cytogenetic and mutation backgrounds. Focus remains on the unblinding of VALOR, the 700-patient Phase III study of vosaroxin in r/r AML, slated for either 3Q or 4Q14. Under 5% of events remain to unblind the study and the company attributes the slowing of the event rate to patients bridging to stem cell transplantation. Unblinding will be a binary event for SNSS, but we believe the previous interim analysis driven upsizing of the study due to favorable characteristics bodes well. SNSS has begun investing in a U.S. launch plan including the hiring of commercial and medical science leadership teams. The company is making preparations for NDA and MAA submissions. VALOR data will be supported by several additional studies including a Phase I/II investigator-sponsored study of vosaroxin in combination with azacitidine in MDS patients at Washington University and a Phase I/II IST in previously treated high-risk MDS at Weill-Cornell.

For an analyst ratings summary and ratings history on Sunesis Pharmaceuticals Inc. click here. For more ratings news on Sunesis Pharmaceuticals Inc. click here.

Sunesis Pharmaceuticals closed at $5.12 yesterday.



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