|Amgen Announces Positive Results From Phase 3 GAUSS-2; Pfizer Reports Top-Line Results From ALO-02 Phase 3 Study|
|By Staff and Wire Reports|
|Thursday, 23 January 2014 20:00|
Amgen (NASDAQ: AMGN) announced that the Phase 3 GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, compared to ezetimibe were consistent with results observed in the Phase 2 GAUSS study.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1
The GAUSS-2 trial evaluated safety, tolerability and efficacy of evolocumab in 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins due to muscle-related side effects. Patients were randomized to one of four treatment groups: subcutaneous evolocumab 140 mg every two weeks and oral placebo daily; subcutaneous evolocumab 420 mg monthly and oral placebo daily; subcutaneous placebo every two weeks and oral ezetimibe 10 mg daily; or subcutaneous placebo monthly and oral ezetimibe 10 mg daily.
Safety was generally balanced across treatment groups. The most common adverse events (> 5 percent in evolocumab combined group) were headache (7.8 percent evolocumab; 8.8 percent ezetimibe), myalgia (7.8 percent evolocumab; 17.6 percent ezetimibe), pain in extremity (6.8 percent evolocumab; 1.0 percent ezetimibe), and muscle spasms (6.3 percent evolocumab; 3.9 percent ezetimibe).
"We are pleased to continue to see promising results from the Phase 3 studies in our comprehensive development program for evolocumab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The positive GAUSS-2 results suggest that evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins."
Data from the Phase 3 GAUSS-2 trial will be submitted to a future medical conference and for publication.
According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C.2 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.3-4 While statins are effective, it is estimated that five to 15 percent of patients cannot tolerate statins, primarily due to muscle-related side effects.5
GAUSS-2 Study Design GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) is a Phase 3 randomized, multicenter, double-blind, placebo- and ezetimibe-controlled trial designed to evaluate the safety, tolerability and efficacy of evolocumab in 307 hyperlipidemic patients who could not tolerate effective doses of at least two different statins due to muscle-related side effects. Patients were randomized to one of four treatment groups: subcutaneous evolocumab 140 mg every two weeks and oral placebo daily; subcutaneous evolocumab 420 mg monthly and oral placebo daily; subcutaneous placebo every two weeks and oral ezetimibe 10 mg daily; or subcutaneous placebo monthly and oral ezetimibe 10 mg daily. The co-primary endpoints were the percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. Secondary efficacy endpoints included means at weeks 10 and 12 and at week 12 for the following: absolute change from baseline in LDL-C; LDL-C < 70 mg/dL; and the percentage change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a), triglycerides, HDL-C and very low-density lipoprotein cholesterol (VLDL-C).
Pfizer Inc. (NYSE: PFE) announced today top-line results from a Phase 3 study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic low back pain. In this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo.
This was a 12-week, double-blind, placebo-controlled, randomized withdrawal design efficacy and safety study in patients with moderate-to-severe chronic low back pain. Patients who achieved a stable and effective dose of ALO-02 (10-80 mg twice per day) during the 4-to-6 week, open-label titration period were randomized (n=281) to the 12-week, double-blind period in which they were either maintained on their current dose regimen of ALO-02 (n=147) or were tapered to placebo (n=134). The primary efficacy endpoint of the study was defined as the difference between ALO-02 and placebo in the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to the final two weeks of the double-blind treatment period. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain). Mean changes in the primary endpoint, NRS-Pain scores from baseline to the final 2 weeks, were significantly different between ALO-02 and placebo.
The most common adverse events with ALO-2 during the double-blind period in this study were nausea, vomiting and diarrhea.
Results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
Amgen (NASDAQ: AMGN) today announced that it will report its fourth quarter and full year 2013 financial results on Tuesday, Jan. 28, 2014, after the close of the U.S. financial markets.
Anavex Life Sciences Corp. (OTCQB:AVXL) today announced that a publication in the current issue of scientific journal Neuropathology potentially extends the opportunity for ANAVEX PLUS to additional neurodegenerative diseases beyond Alzheimer's.
Atossa Genetics Inc. (NASDAQ: ATOS) today announced that it intends to offer units consisting of shares of common stock and warrants in a public offering. While the offering is expected to price before 9:30 am EST on January 24, 2014, the offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, today announced its CEO Panna Sharma will present at the 4th Annual Life Science Chief Executive Officer Forum on January 30, 2014 at 4:15 p.m. ET.
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that the Biomedical Advanced Research and Development Authority ("BARDA") has terminated negotiations related to the Company's proposal for further development of Entolimod as a medical radiation countermeasure, noting that all such negotiations are subject to the availability of funds.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement with Galaxy Health Network for coverage of CombiMatrix's diagnostic laboratory services.
The Cooper Companies, Inc. (NYSE:COO) today announced the appointment of Randal L. Golden to General Counsel, effective February 1, 2014. Golden will be responsible for the Company's global legal affairs.
Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) (OTCQX:CYNAF), a specialty pharmaceutical company, today announced that in January, 125,324 warrants with an exercise price of $0.575 have been exercised for total proceeds of $72,062.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that its executive chairman James Czirr will present during the RedChip Emerging Growth Showcase on Thursday, January 23, 2013 at 11:30 a.m. Eastern Standard Time.
Kips Bay Medical, Inc. (Nasdaq:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, the eSVS® Mesh, for use in coronary artery bypass grafting surgery, today announced its intention, subject to market and other conditions, to commence a public offering of its common stock.
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX™—a corporate portfolio company of Medical Marijuana, Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc.— is accelerating the Company's strategic plan to educate the public on benefits of cannabidiol (CBD)-rich hemp oil dietary supplements, personal care, lifestyle, and anti-aging products.
Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced enrollment of its first patient in a Phase 1 dose-escalating clinical study of MM-398 in conjunction with cyclophosphamide for the treatment of pediatric solid tumors. MM-398 is a stable nanoliposomal irinotecan that is designed to exploit leaky tumor vasculature for enhanced drug delivery to tumors.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that results from four studies in prostate cancer with Prolaris® and one study in renal cancer will be presented at the 2014 ASCO Genitourinary Cancers Symposium, which will be held Jan. 30-Feb. 1, 2014 in San Francisco, Calif.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it will issue financial results for the second fiscal quarter 2014 following the close of market on Tuesday, February 4, 2014.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has published a report on the current market opportunities for its homeland security and medical diagnostics technologies.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that Health Canada has completed a successful on-site evaluation of the Company's manufacturing facility in Carmiel, Israel, as part of its ongoing review of the new drug submission (NDS) for taliglucerase alfa for the treatment of Gaucher disease.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding and cell adhesion, announced today that, pursuant to its License, Development, and Commercialization Agreement with Roche, it will receive the $30 million upfront payment from Roche as a result of the License Agreement having become effective upon the expiration of the Hart-Scott-Rodino waiting period.
PPJ Enterprise (OTC Pink: PPJE) a proprietary automated health care software company, is pleased to share new developments in its collection litigation.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) today announced that certain subsidiaries of Sabra (the "Issuers") had received as of 5:00 p.m., New York City time, on January 22, 2014 (the "Consent Expiration"), tenders and consents from the holders (the "Holders") of approximately $210.9 million in aggregate principal amount, or approximately 99.8%, of the Issuers' outstanding 8.125% Senior Notes due 2018 (the "Notes") in connection with their previously announced cash tender offer (the "Offer") to purchase any and all of the Notes and the related solicitation of consents ("Consent Solicitation") from Holders of the Notes to proposed amendments that would eliminate substantially all of the restrictive covenants and certain events of default provisions (the "Proposed Amendments") contained in the indenture governing the Notes (as supplemented, the "Indenture").
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) announced its outlook for the year ending December 31, 2014, Sabra's board of directors declared quarterly cash dividends of $0.36 per share of common stock and $0.4453125 per share of Series A Preferred Stock, and Sabra announced the completion of $44.8 million of mortgage debt refinancing with HUD.
Spherix Incorporated (NASDAQ: SPEX), an intellectual property development company committed to the fostering and monetization of intellectual property, announced today that its annual meeting of stockholders scheduled for, and convened on January 22, 2014, was adjourned due to the lack of requisite quorum.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced it will release results for the fourth quarter of 2013 on Thursday, February 13, 2014, before the market opens.
WEALTHMAKERS.COM, a Wall Street research and trading firm providing unbiased statistical stock market predictions to empower investors, securities professionals and public company employees to make precise, predictive and profitable trading decisions, has issued a new research report today on Nuvilex, Inc. (OTC:NVLX).