Enrollment in Expansion Phase of Trials, Results and Initiation of Phase 2 Studies and Stock Movements - Analyst Notes on Pfizer, Cytokinetics, Portola Pharmaceuticals, Volcano, and Array BioPharma
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NEW YORK, April 9, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Pfizer Inc. (NYSE: PFE), Cytokinetics, Incorporated (NASDAQ: CYTK), Portola Pharmaceuticals, Inc. (NASDAQ: PTLA), Volcano Corporation (NASDAQ: VOLC), and Array BioPharma, Inc. (NASDAQ: ARRY). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.AnalystsReview.com/register
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Pfizer Inc. Analyst Notes
On April 6, 2014, Pfizer Inc. (Pfizer) released detailed results from the PALOMA-1 study. According to the release, PALOMA-1, a randomized Phase 2 study of palbociclib (PD-0332991) in combination with letrozole, has achieved its primary endpoint by significantly extending progression-free survival (PFS) compared with letrozole alone in postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Pfizer stated that for women who were treated with the combination of palbociclib plus letrozole, the median PFS was 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who received letrozole alone (HR=0.488 [95% CI: 0.319, 0.748]; p=0.0004). Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology, stated, "These data demonstrate the potential of palbociclib to be a major advance in the treatment of women with this type of advanced breast cancer. We are proud to be at the forefront of research and development with respect to this promising new class of investigational anticancer agents and have initiated a broad clinical development program for palbociclib that includes breast and non-breast cancers." The full analyst notes on Pfizer Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/PFE/report.pdf
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Cytokinetics, Incorporated Analyst Notes
On March 28, 2014, Cytokinetics, Incorporated (Cytokinetics) announced that the COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) expansion phase, has opened for enrollment. Cytokinetics stated that COSMIC-HF is a Phase II double-blind, randomized, placebo-controlled, multicenter clinical trial designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosing orally in patients with heart failure and left ventricular systolic dysfunction. According to the Company, the COSMIC-HF expansion phase will enroll approximately 450 patients randomized 1:1:1 to receive placebo, 25 mg, or 50 mg twice daily of omecamtiv mecarbil, with an escalation to the 50 mg dose depending on the plasma concentration of omecamtiv mecarbil following 2 weeks of oral dosing at 25 mg twice daily. Cytokinetics' Senior Vice President of Clinical Research and Development and Chief Medical Officer, Andrew A. Wolff, M.D., FACC, stated, "The opening to enrollment of the expansion phase of COSMIC-HF is an important step forward in the evaluation of a plasma concentration-guided dose titration strategy for omecamtiv mecarbil in patients with heart failure. This international clinical trial has the potential to inform further clinical development strategies for omecamtiv mecarbil." The full analyst notes on Cytokinetics, Incorporated are available to download free of charge at:
http://www.AnalystsReview.com/04092014/CYTK/report.pdf
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Portola Pharmaceuticals, Inc. Analyst Notes
On March 27, 2014, Portola Pharmaceuticals, Inc. (Portola Pharmaceuticals) announced that it has initiated a Phase 2 proof-of-concept study to evaluate andexanet alfa, the potential First-in-Class Factor Xa Inhibitor Reversal Agent as a reversal agent for Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban in healthy volunteers. According to the release, the Company is pursuing an Accelerated Approval pathway for andexanet alfa, the only agent that has demonstrated reversal of the anticoagulation activity of Factor Xa inhibitors treated patients who are suffering a major bleeding episode or who require emergency surgery. John T. Curnutte, M.D., Ph.D., Executive Vice President, Research and Development at the Company, stated, "Our development team leveraged our cutting-edge science in the area of thrombosis to create andexanet alfa as a possible solution. The initiation of this new Phase 2 study with edoxaban moves us closer to our goal of bringing andexanet alfa to market as a universal antidote for Factor Xa inhibitors." According to the Company, in the said clinical collaboration between Portla Phamaceuticals and Daiichi Sankyo for the Phase 2 study Daiichi Sankyo provides funding for the study while Portola retains full worldwide commercial rights to andexanet alfa. The full analyst notes on Portola Pharmaceuticals, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/PTLA/report.pdf
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Volcano Corporation Analyst Notes
On April 4, 2014, Volcano Corporation's (Volcano) stock dipped by 3.76%, closing the day at $19.73 per share. However, for the past five day trading period, the Volcano shares increased by 2.07% compared to the Nasdaq Composite which declined by 0.67% during the same period. The full analyst notes on Volcano Corporation are available to download free of charge at:
http://www.AnalystsReview.com/04092014/VOLC/report.pdf
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Array BioPharma, Inc. Analyst Notes
On April 4, 2014, Array BioPharma, Inc.'s (Array BioPharma) shares slipped by 5.01%, closing at $4.17 per share. Over the previous six month trading session, Array BioPharma stock price reflected a decrease of 35.75%, compared to the Nasdaq Composite which increased by 8.40% during the same trading period. The full analyst notes on Array BioPharma, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/ARRY/report.pdf
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