Tag Archives: Oral Presentation

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Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vanip

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Merck to Present New Data on VICTRELIS ® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver Congress TM / 2013 EASL Annual Meeting

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck’s investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting. The meeting will take place in Amsterdam from April 24-28, 2013.

Key Presentations About VICTRELIS 200 mg Capsules

  • Safety And Efficacy Of Boceprevir/Peginterferon/Ribavirin (Boc/P/R) Combination Therapy For Chronic HCV G1 Patients With Compensated Cirrhosis: A Meta-Analysis Of Five Phase III Clinical Trials, J.M. Vierling et al. Late Breaker. Thursday, April 25, 9:00- 18:00. RAI Convention Centre.
  • Virologic Response Rates Are Similar In Previously Untreated And Previously Treated And Relapsed Patients Receiving Boceprevir Triple Therapy: A Retrospective Analysis. Bacon, B. et al. Poster 791. Friday, April 26, 12:30-14:00. RAI Convention Centre.

Key Investigational Compound Presentations

  • High Sustained Viral Response at 12- and 24-week follow-up of MK-5172 with Pegylated Interferon alfa-2b and Ribavirin (PR) in HCV Genotype 1 Treatment-naïve Non-cirrhotic Patients. Manns, M. et al. Oral Presentation: Friday, April 26, 16:00-18:00, RAI Convention Centre.
  • MK-5172 In Combination With Peg-Interferon And Ribavirin Elicits Limited Resistance While Demonstrating Robust Efficacy In Treatment Naïve Genotype 1 Chronic HCV-Infected Patients. Howe, A. et al. Poster 1197. Saturday, April 27, 12:30-13:30. RAI Convention Centre.
  • Sustained Viral Response And Safety Of MK-7009 In Cirrhotic Treatment-Experienced Patients With Genotype 1 HCV Infection Who Have Failed Previous Pegylated Interferon And Ribavirin Treatment. Rodriguez-Torres, M. et al. Oral Presentation. Saturday, April 27, 8:30-10:30. RAI Convention Centre.

“We are pleased to present new data on VICTRELIS that will help inform health care professionals as they consider the use of VICTRELIS in appropriate patients,” said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Advaxis Announces Abstract Accepted for Oral Presentation at SITC Cancer Immunotherapy Clinical Tria

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Advaxis Announces Abstract Accepted for Oral Presentation at SITC Cancer Immunotherapy Clinical Trials Workshop

PRINCETON, N.J.–(BUSINESS WIRE)– Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that an abstract has been accepted for oral presentation at The Society for Immunotherapy of Cancer (SITC) Cancer Immunotherapy Clinical Trials: Concepts and Challenges workshop being held April 4-5, 2013 at the National Institutes of Health Campus (Masur Auditorium) in Bethesda, MD.

The abstract titled “Early Therapeutic Cancer Vaccine Clinical Trial Development” will be presented Thursday, April 4 at 10:30 am during Session 1 by Dr. Robert Petit, VP of Clinical Development and Medical Affairs at Advaxis, and will describe Advaxis’ experience with conducting early clinical trials with therapeutic Lm-LLO immunotherapies.

“The selection of our abstract for presentation at SITC provides an opportunity for Advaxis to share our experience in introducing Lm-LLO immunotherapy in a global clinical trial setting where there is great medical need,” commented Dr. Petit. “We are working toward a future when immunotherapy can fully take its place alongside conventional treatments in the global battle against cancer.”

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacteriumto the cancer itself.

In April 2012, Advaxis’ lead construct, ADXS-HPV, was selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines. The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months. Additional information is available at the World Vaccine Congress website.

ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), head & neckcancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trial.gov Identifier NCT01671488). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of …read more
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Business, Finance, Occupation & Industry

Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Car

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Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference

ST. PAUL, Minn., & SAN FRANCISCO–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , will present data from its ORBIT II study of coronary artery disease at the 2013 American College of Cardiology (ACC) conference in San Francisco, Mar. 9-11, 2013. This marks the first time CSI will share results from this landmark pivotal trial, which is the first Investigational Device Exemption (IDE) study in history to seek approval for treating severely calcified coronary lesions.

ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating this problematic subset of patients. Moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, according to estimates. Moderate to severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse coronary events. A coronary application would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. CSI is targeting the end of March to submit its Premarket Approval application to the Food and Drug Administration (FDA).

…read more
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Oral Presentation at ACC: Mar. 9