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Andrew Nava LLC is a healthcare focused consulting and investment firm. Prior to launching Andrew Nava LLC, I was a venture analyst, buy-side analyst, and most recently, the Director of Research at Actin Biomed, a New York-based healthcare investment firm where I was responsible for the medical,... More
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  • ASCO Watch: ABII, ARIA, CYCC, PCYC 2 comments
    Apr 12, 2010 9:56 AM | about stocks: ABII, ARIA, CYCC, PCYC
    ASCO (The American Society of Clinical Oncology 2010 Annual Meeting) is approaching (June 4-8, 2010).  Here's a short list of companies who are presenting new or updated data:

    Abraxis BioScience (ABII)

    ABII reported top-line data on March 17, 2010 from its Phase 3 NSCLC trial evaluating Abraxane + Carboplatin vs Taxol + Carboplatin.  ABII reported that the study's primary endpoint of overall response rate (powered for superiority) was greater in the Abraxane/Carb arm than in the Taxol/Carb arm.  ABII submitted the data for consideration as a late breaking presentation at ASCO.  ABII also mentioned that they are expecting survival data from its ongoing Phase 2 pancreatic cancer study in time for an ASCO late-breaker.

    Ariad Pharmaceuticals (NASDAQ:ARIA)

    ARIA has numerous upcoming catalysts, including a second interim analysis of its Ridaforolimus (Rida) pivotal trial evaluating 2/3 of the study's PFS events (expected 2Q10), and a possible renegotiation of the Rida agreement with Merck (also expected in 2Q10).  At ASCO, ARIA will be presenting updated AP24534 Phase 1 data in CML patients, including data on durability of hematologic and cytogenetic responses and results from the new dosing cohort.  In December, ARIA presented data at ASH demonstrating that in 20 chronic phase CML patients, five (5) patients had a complete cytogenetic response, nine (9) patients had a major cytogenetic response, and 12 patients had a cytogenetic response. Additionally, complete hematologic responses were seen in ten (10) of 12 chronic phase CML patients and three (3) major hematologic responses in four (4) accelerated phase patients. At ASH, ten (10) out of 18 CML patients had the T315I mutation with nine (9) of those patients remaining on study.

    Cyclacel Pharmaceuticals (NASDAQ:CYCC)

    CYCC is expected to report interim data from its phase 2 sapacitabine trial in MDS patients.  At ASH, CYCC had completed enrollment of 60 elderly MDS patients across three arms previously treated with azacitidine and/or decitabine. Each arm enrolled 20 patients randomized across the same three dosing schedules of sapacitabine (Arms A, B and C). The highest number of responses were observed on Arm B, the 7-day high dose schedule. Thirty-day mortality from all-causes was 8.2% with approximately 30% of the patients receiving four (4) or more cycles of therapy.  On a separate note, CYCC submitted an SPA for AML patients in 1Q10.  The FDA has 45 days to respond to the SPA submission, although no assurances are given that the first submission will result in the granting an SPA. 

    Pharmacyclics (NASDAQ:PCYC)

    PCYC is expected to present updated data on PCI-32765, a Bruton’s tyrosine kinase (Btk) inhibitor currently in a Phase 1 trial for patients with relapsed or refractory lymphomas.  Interim data at ASH on 16 heavily pretreated and progressing lymphoma patients demonstrated 2 PRs (partial responses) in the 1st dose cohort (1 mantle cell, 1 follicular), 3 PRs in the second dose cohort (1 mantle, 2 CLL/SLL) and two SDs (stable disease) over two (2) cycles of therapy, and three (3) PRs in the third dose cohort, all with CLL/SLL.  PCYC is expected to present updated data from the third dose cohort as well as preliminary data on cohorts four and five.

    All the information above is derived from andrewnava.com which contains close to 1000 upcoming biotech catalysts spread across 17 different catalyst types, including PDUFA dates, complete response letter responses, expected NDA filings and acceptances, upcoming Phase 1, 2 and 3 data, earnings dates and notes, sales guidance, expected government contracts, and much more.  Additionally, the database tracks all clinical and regulatory data from over 280 publicly-traded biotech companies - useful for researching past trials, results, and regulatory strategies.

    Find out more at andrewnava.com


    Disclosure: ABII, ARIA, CYCC, PCYC: No positions
    Stocks: ABII, ARIA, CYCC, PCYC
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  • Tom Demian
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    Comments (489) | Send Message
     
    dont forget Sunesis and vorolexin
    29 May 2010, 09:03 PM Reply Like
  • Andrew Nava
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    Comments (3) | Send Message
     
    Author’s reply » Here's a more recent post seekingalpha.com/insta...
    30 May 2010, 02:43 AM Reply Like
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