|Gilead Reports Preclinical Data; Bristol-Myers Squibb Launches Phase III Trial Of HIV Drug|
|By Josh Gee|
|Wednesday, 25 February 2015 20:06|
Gilead Sciences, Inc. (NASDAQ:GILD) announced results from a preclinical study conducted in collaboration with researchers at Beth Israel Deaconess Medical Center evaluating a proprietary investigational oral toll-like receptor 7 (TLR7) agonist and analogue of GS-9620 as part of an HIV eradication strategy. Data demonstrate that treatment with the TLR7 agonist induced transient plasma Simian Immunodeficiency Virus (SIV) RNA, as well as reduced SIV DNA in virally suppressed rhesus macaques given antiretroviral therapy (ART). In addition, the study found that after discontinuation of ART, SIV viral loads were lower among macaques that received the proprietary TLR7 agonist compared to the placebo group. These data were presented in an oral session (Session O-9) at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
“One reason current therapies can’t cure HIV is that latent reservoirs of the virus persist even among individuals who are virally suppressed on ART,” said James Whitney, PhD, Assistant Professor of Medicine, Harvard Medical School, and study Principal Investigator in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. Dr. Whitney is also an Associate Member of The Ragon Institute of MGH, MIT and Harvard, which was founded in 2009 to contribute to the accelerated discovery of an HIV/AIDS vaccine and to establish itself as a world leader in the collaborative study of immunology. “These data demonstrate that, given alongside ART, the TLR7 agonist may have the potential to both stimulate virus production and eliminate latently infected cells – an eradication strategy being explored today.”
In this placebo-controlled study, 10 SIV-infected rhesus macaques received ART for 38 weeks, at which point they were virally suppressed (plasma RNA less than 50 copies/mL). At week 38, six macaques were given placebo and four macaques were given seven bi-weekly doses of the TLR7 agonist, while maintaining ART. Total viral DNA levels were measured at baseline and two weeks after completion of the TLR7 agonist dosing in peripheral blood mononuclear cells (PBMC), colon and inguinal lymph nodes – where latent SIV reservoirs are common. ART was discontinued two weeks after the final dose of the TLR7 agonist to assess plasma viral rebound.
The four macaques receiving bi-weekly doses of the TLR7 agonist were given 0.1 mg/kg for the first dose, 0.2 mg/kg for the second dose and 0.3 mg/kg for each of the last five doses. Doses 1-3 had no effect on plasma viremia, whereas doses 4-7 led to transient and consistent increases in plasma virus (500-1,000 SIV RNA copies/mL) in all four macaques with a return to less than 50 copies/mL within four to seven days after receiving the TLR7 agonist. In addition, SIV DNA levels of the four treated macaques were reduced by 30 to 90 percent compared to the placebo group, which remained unchanged. Following discontinuation of ART in the macaques that received the TLR7 agonist, plasma SIV RNA was ~0.5 log10 lower compared to the placebo group.
“These preliminary results suggest that TLR7 agonists may have a role to play in HIV eradication strategies,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “GS-9620 is a potent TLR7 agonist currently being evaluated in a Phase 2 study in patients with chronic hepatitis B for its potential to reduce HbSAg. Based on today’s results, we are now also looking forward to moving GS-9620 into proof-of-concept studies in HIV-infected individuals taking ART.”
The proprietary TLR7 agonist compound and GS-9620 are investigational agents and their safety and efficacy have not been established.
Bristol-Myers Squibb Co (NYSE: BMY) launched a Phase III trial of an experimental HIV treatment for patients who have become resistant to other therapies. Shares of the pharmaceuticals giant changed hands recently at $61.35, down 0.16 percent.
Positive interim results of an ongoing Phase IIb safety trial enabled launch of the Phase III clinical trial on Monday, Bristol-Myers said. After 48 weeks, the safety trial didn't result in serious adverse events or safety concerns related to dose responses.
Results of the safety trial were presented Tuesday at a Seattle conference on retroviruses and opportunistic infections. The clinical development program for the drug, Fostemsavir, or BMS-663068, "exemplifies our commitment to focusing on patients living with HIV who have high unmet needs," according to Douglas Manion, head of specialty development, Bristol-Myers Squibb.
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Robert L. Bowen, Vice President & Chief Financial Officer, will present at the Cowen and Company 35th Annual Health Care Conference on Wednesday, March 4, 2015 at 11:20 a.m. EST.
Actavis plc (NYSE: ACT) today announced the U.S. Food and Drug Administration (FDA) has approved AVYCAZ™ (ceftazidime-avibactam). AVYCAZ was approved for the treatment of adult patients with complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
Allscripts (Nasdaq:MDRX) client St. Clair Hospital (Mt. Lebanon, Pa.) received the 2014 HIMSS Enterprise Davies Award for its success in improving patient outcomes and its financial results through the use of health information technology.
Amedisys, Inc. (Nasdaq:AMED) today announced for the third year in a row it has proven clinical excellence with its Speech-Language Pathology (SLP) program as evidenced by the American Speech-Language and Hearing Association (ASHA) National Outcomes Measurement System (NOMS) report for 2014.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced that the Company will issue its financial results for the fourth quarter of 2014 on Monday, March 9, 2015, after the close of the market, and will hold a conference call on this day at 4:30 p.m. ET to discuss the financial results and provide a company update.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the pricing of an underwritten public offering of 7,250,000 shares of its common stock, offered at a price to the public of $24.00 per share for an aggregate offering of $174.0 million of common stock.
Cellular Dynamics International, Inc. (Nasdaq:ICEL) today announced that the company will host a webcast and conference call to discuss its financial results for the fourth quarter and for the fiscal year ended December 31, 2014.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the quarter and year ended December 31, 2014 and provided an update on recent corporate developments.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix, will present at the Cowen & Co. 35th Annual Health Care Conference on Tuesday, March 3, 2015 at 9:20 am EST at the Boston Marriott Copley Place Hotel in Boston.
CollabRx, Inc. (Nasdaq:CLRX) today announced the closing of its previously announced underwritten public offering of 3,840,000 shares of its common stock and warrants to purchase up to an aggregate of 3,840,000 shares of its common stock at an offering price of $1.25 per common share and $0.0001 per warrant.
CollabRx, Inc. (Nasdaq:CLRX) today announced that it intends to offer for sale shares of its common stock in an underwritten public offering.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today reported financial results for the fourth quarter and full year ended December 31, 2014.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, announced today that Kevin Connors, the Company's President and CEO, will be presenting at the 27th Annual Roth Conference to be held March 9 – 12, 2015 at the Ritz Carlton in Laguna Niguel, California.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced that Christian Weyer, M.D., M.A.S., President and Chief Executive Officer, will present at the Cowen & Company 35th Annual Health Care Conference on Wednesday, March 4, 2015 at 11:20 am EST in Boston, MA.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), today announced that Mike Kosloske, Chief Executive Officer, and Dirk Montgomery, Chief Financial Officer, of HII will present an overview of the company Monday, March 2, 2015 at 2:15 p.m. Eastern Time at the Raymond James & Associates 36th Annual Institutional Investors Conference to be held March 1-4, 2015 at the JW Marriott Grande Lakes in Orlando, Florida.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the company is scheduled to present at the Cowen and Company 35th Annual Health Care Conference on Tuesday, March 3, 2015 at 10 a.m. EST.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), a provider of peripheral vascular devices and implants, today reported Q4 2014 results.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, today announced its financial results for the three months and year ended December 31, 2014.
Lion Biotechnologies, Inc. (OTCBB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL), today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering.
MedAssets (Nasdaq:MDAS) today announced that its latest National Collaborative event, a sourcing program designed to generate cost reductions for products and services through pre-committed purchasing volume, will drive an estimated $2 million in savings annually in the linen and apparel category.
MediciNova, Inc., (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has been invited to and will present data and Phase 2 clinical study design regarding MN-001 (tipelukast) during the American Association for the Study of Liver Diseases (AASLD) and Industry Colloquium: Novel Targets and Therapies in Liver Disease, to be held March 20-21 in Durham, North Carolina.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced its fourth quarter and full year 2014 financial results.
Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced that William Lis, chief executive officer, will present at the Cowen and Company 35th Annual Health Care Conference on Tuesday, March 3, 2015 at 8:40 a.m. Eastern Time in Boston.
Richard E. Perlman, Executive Chairman and James K. Price, Chief Executive Officer of ExamWorks Group, Inc. (NYSE:EXAM), will present at the Barclays Global Healthcare Conference, March 12th at 10:45 a.m. The conference will be held at the Loews, Miami, Florida.
Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, announced today that it will release its fourth quarter and full year 2014 financial results on Wednesday, March 11, 2015 after the market close.
Wright Medical Group, Inc. (Nasdaq:WMGI) today reported financial results for its fourth quarter and full-year ended December 31, 2014 and provided 2015 guidance. As a result of the completed sale of the hip and knee business to MicroPort Medical B.V., a subsidiary of MicroPort Scientific Corporation (MicroPort), this business is reported as discontinued operations.