Tag Archives: Merck

Merck Nearing FDA Approval For Its Antitoxin (bezlotoxumab) For Prevention Of C. difficile Infection (CDI) Recurrence

Merck  is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency’s priority review designation with the promise of a shortened vetting process.

The FDA accepted Merck’s application for bezlotoxumab and promised to hand down a final decision by July 23, shortening the standard 10-month review to 6 months.

The treatment, licensed from Medarex in 2009, is an antibody designed to block C. difficile toxin B, which damages the gut wall and leads to inflammation that trigger abdominal pain and diarrhea. In Phase III, adding bezlotoxumab to standard of care significantly reduced C. difficile recurrence in high-risk patients after 12 weeks, Merck disclosed in September.

Bezlotoxumab is among the most advanced assets in Merck’s infectious disease pipeline, bolstered by the company’s $9.5 billion buyout of antibiotics specialist Cubist Pharmaceuticals last year. Merck is also at work on therapies for pneumonia, bacterial infection and HIV as it awaits approval for a combination treatment targeting hepatitis C.

 

FULL STATEMENT FROM MERCK:

Merck  known as MSD outside the United States and Canada  January 28, 2016  (today) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016.

The company also has filed a marketing authorization application for bezlotoxumab with the European Medicines Agency (EMA) that is currently under review.

“Recurrence is a major challenge with C. difficile infection, one of the most common healthcare-associated infections in U.S. hospitals,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Currently, there are no therapies approved for the prevention of C. difficile infection recurrence. As part of Merck’s commitment to the fight against infectious diseases, we look forward to continuing to work with the FDA and EMA to bring forward this novel medicine for appropriate patients.”

The application for bezlotoxumab is based in part on data from the pivota lMODIFY I and MODIFY II clinical trials. Data from these trials were previously presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 joint meeting.

About bezlotoxumab

Bezlotoxumab is an investigational antitoxin given in conjunction with standard of care antibiotics that are used in the treatment of C. difficile infection. It is not an antibiotic. Bezlotoxumab is designed to neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to C. difficile-associated diarrhea.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visitwww.merck.com and connect with us on TwitterFacebookYouTube and LinkedIn.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

To read this article in its entirety please click on the link below:

http://www.fiercebiotech.com/press-releases/merck-announces-fda-acceptance-biologics-license-application-bezlotoxumab-i

 

AccessDIFICID (fidaxomicin) Is A Support Program For Patients Prescribed DIFICID®

Dificid (fidaxomicin)  Product Access and Support Information:

AccessDIFICID is a support program for patients who have been prescribed DIFICID® (fidaxomicin) tablets.

Case managers are available M-F, 8 am – 8 pm; SAT, 9 am – 1 pm, ET, to provide the following information and support:

  • Research your insurance benefits
  • Obtain information about your out-of-pocket costs
  • Provide information on co-pay assistance options
  • Provide a referral to the Patient Assistance Program (PAP)
  • Provide information about local pharmacies that stock DIFICID and/or options for overnight deliveries of DIFICID, where available, to the location of your choice
  • Answer questions about filling out the AccessDIFICID Enrollment Form

Getting started is simple

  • Download and complete the appropriate sections of the AccessDIFICID Enrollment Form with your health care provider
  • You or your health care provider can fax the completed form to 1-888-997-9329
  • A program representative will then contact you and your health care provider’s office
After your intake form has been processed, you will receive a phone call from an AccessDIFICID case manager, who will work with you throughout the process. You may also contact a case manager at 1-844-282-4782 (M-F, 8 am – 8 pm; SAT, 9 am – 1 pm, ET).

 For continued information for AccessDIFICID please click on the following link:

http://www.accessdificid.com/

 

*The C Diff Foundation does not endorse this or any medical and non-medical treatment available for the
treatment of a C. difficile infection.  All possible treatment options are strictly information
based and for the general public and for general knowledge.   Discuss all treatment options
with the physician/s providing care for and and all diagnosis.  *

C. difficile, a leading Healthcare-Associated Infection, Brings Together World Topic Experts At the International Raising C. diff. Awareness Conference and Health EXPO in Boston, MA on November 9th

 2015 International Raising C. diff. Awareness Conference & Health EXPO

Boston, MA, USA   ~    November 9th

7:30 a.m – 5:00 p.m

Join us at our 3rd annual International Raising C. diff. Awareness Conference and Health EXPO on November 9th.  Not just another educational conference but one that pairs
world-renowned topic experts with presentations on state-of-the-art health care topics pertaining to a leading Healthcare-Associated Infection (HAI); C. difficile

*Prevention
*Treatments
*Research
*Prevention and Treatment Clinical trials and studies
*Microbiome research
*Infection Prevention
*Environmental Safety
*Fecal Microbiota Restoration and Transplants
……………………..and much more.

The panel of world-renowned topic experts will also discuss the burden of C. diff. the risk factors pertaining to current and emerging treatment options along with the importance of applying evidence-based clinical approaches to the prevention of  a C. diff. infection (CDI), one of the leading Hospital-Acquired Infections.

Clostridium difficile (also known as C. diff.) is an important cause of infectious disease death in the United States.  Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC). • More than 100,000 of these infections developed among residents of U.S. nursing homes alone.*  Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection.   Of these 29,000 – 15,000 deaths were estimated to be directly related to a  C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.  (Source: CDC)

Conference Venue:

Double Tree Suites Hotel – Boston – Cambridge
400 Soldiers Field Road, Boston, MA  02134  USA
1-617-783-0090 For Hotel Accommodations *   * There are hotel accommodations available for Sunday evening offered at a special event rate for guests of the C Diff Foundation.  Please inform the DoubleTree representative at the time of creating a reservation to receive the special event room rate.

Exclusive Admission:   $75.00

Student Admission:     $50.00

Each exclusive and student ticket includes admission to all presentations, formal and informal Q&A sessions, introductions to fellow healthcare professionals, continental breakfast  (7:30 a.m.) , a plated four course luncheon with the choice of Chicken Florentine or Petite Filet Mignon main entree, Access to the Health EXPO, a conference book, a educational DVD, and formal conference program.  

To Register and obtain tickets, please click on the following link

NOTE:  *Presentations should not be recorded audio or video or published without prior written and signed permission from the guest speaker and addressed by each attendee seeking publication of said presentations.

Guest Speakers

Key Speaker and Conference Chair:  Professor Mark Wilcox;  Professor of Medical Microbiology, Leeds Institute of Biomedical and Clinical Sciences, UK. Professor Mark Wilcox is a Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology at the Leeds Teaching Hospitals, Professor of Medical Microbiology at the University of Leeds, and is the Lead on Clostridium difficile for the Public Health England. He has formerly been the Director of Infection Prevention, Infection Control Doctor and Clinical Director of Pathology at Leeds Teaching Hospitals.

Dr. John Bartlett, MD; Assistant Professor Medicine, UCLA/Sepulveda Veterans Admin Hospital 1972-5, Associate Professor and Professor of Medicine, Tufts University School of Medicine, Boston, 1975-80, Professor of Medicine and Chair Division of Infectious Diseases Division, Johns Hopkins University School of Medicine 1980 – 2006; Professor of Medicine, 2006 – 13; Professor of Medicine emeritus, Johns Hopkins University School of Medicine, 2013.Dominant research interests: anaerobic infections and pulmonary infections 1968 – 74; community acquired pneumonia and diagnostic methods, 1974-1980; Bowel prep for elective colon surgery; Protected bronchoscopy brush catheter-1977; Clostridium difficile 1977 – 84, HIV 1983 – 2014; bioterrorism 1999 –2004; Clostridium difficile infection, HIV/AIDS and antibiotic resistance 2006-2013 with  Major current interests: Clostridium difficile infection, HIV infection, antibiotic resistance, careers in infectious diseases.
Presentation Topic: “The discovery of Clostridium difficile as the cause of antibiotic-associated colitis.”

Professor Simon M. Cutting, Professor of Molecular Microbiology at Royal Holloway, University of London is a bacterial geneticist with over 25 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. His D.Phil was on understanding the genetic control of spore formation in Bacillus. After spending 7 years in the renowned laboratory of Professor Richard Losick at Harvard University Biological Laboratories (USA) he spent 3 years as an Assistant Professor at the University of Pennsylvania Medical School in Philadelphia. He returned to the UK in 1996 and since then has worked on developing bacterial spores as novel oral vaccines at
Royal Holloway, University of London. The Cutting lab has developed a number of prototype oral vaccines and is now entering a ‘first in man’ phase 1/IIa clinical trial of a prototype oral vaccine to 
Clostridium difficile (see www.cdvax.org). His other expertise is in the use of Bacillus spores as probiotics and has a number of contracts and consultancies with European and US companies in the food and feed sectors 
(see SporeGen.com).
Presentation Topic: “Mucosal Vaccination: Decolonisation is Essential to Full Protection Against C. difficile

Dr. Sadeq A. Quraishi, MD, MHA, MMSc   Anesthesiologist/Intensive Care physician in the Department of Anesthesia, Critical Care and Pain Medicine at the Massachusetts General Hospital in Boston, MA. He is also Assistant Professor of Anaesthesia at Harvard Medical School in Boston, MA. Dr. Quraishi’s overall research goal is to better define how macro- and micro-nutrient status influence outcomes during acute stress and critical illness. In particular, his research group has focused on the immunomodulatory effects of vitamin D in the perioperative setting, during acute care hospitalization, and for patients in the intensive care unit. Recently, Dr. Quraishi’s group has identified vitamin D status as a potentially modifiable risk factor for hospital acquired C. diff infections and that the severity of C. Diff infections may also be related to vitamin D status .
Presentation Topic:  “Vitamin D as nutritional immunomodulation
for Clostridium difficile infections.”

Dr. Mary Beth Dorr , Phd, studied Pharmacy at the University of the Sciences in Philadelphia and received a PhD in pharmacokinetics and drug metabolism from the University of North Carolina. For the last 28 years Dr. Dorr has worked in the pharmaceutical industry in various capacities, with the majority of the time devoted to the design and implementation of Phase 1 to 4 clinical trials, primarily for anti-infective products.  Prior to joining Merck, Dr. Dorr directed several large, international clinical studies of the efficacy and safety of two IV antibiotics, Synercid and dalbavancin.  She also directed clinical research programs for gastrointestinal and women’s health products.  Mary Beth joined Merck in February 2011 and is currently a Clinical Director in the Late Stage Clinical Development Department as the Clinical Monitor directing 2 large pivotal Phase 3 trials investigating the safety and efficacy of the monoclonal antibodies actoxumab and bezlotoxumab as adjunctive therapy for the prevention of C. difficile recurrence.
Presentation Topic: Bezlotoxumab for Prevention of Recurrent C. difficile Infection in Patients on Standard of Care Antibiotics:  Results of Phase 3 Trials (MODIFY I and MODIFY II)

Dr. Hudson Garrett, Jr., PhD, MSN, MPH, FNP, CSRN, VA-BC, CDONA,FACONA,DON-CLTC
Dr. Hudson Garrett is currently employed as the VP, Clinical Affairs for PDI and NIce-Pak, and is responsible for the global Clinical Affairs program and also the Medical Science Liaison program for all divisions within the company. He holds a Bachelor of Science degree in Biology/Chemistry and Nursing, a dual Masters in Nursing and Public Health, Post-Masters Certificate as a Family Nurse Practitioner, a Post-Masters Certificate in Infection Prevention and Infection Control and a PhD in Healthcare Administration and Policy. He has completed the Johns Hopkins Fellows Program in Hospital Epidemiology and Infection Control, and the CDC Fundamentals of Healthcare Epidemiology program, and is board certified in family practice, critical care, vascular assess, moderate sedation, legal nurse consulting, and a director of nursing in long term care.  Dr. Garrett is also a Fellow in the Academy of National Associations of Directors of Nursing Administration in Long Term Care.
Presentation Topic:  Preventing Clostridium difficile thru Antibiotic Stewardship

Dr. David Cook, PhD;  A scientist and entrepreneur who has held senior operating and management positions in the biotechnology industry over his 20-year career. Before joining Seres Therapeutics, he was the chief operating officer for the International AIDS Vaccine Initiative, a global R&D organization whose mission is to develop a safe, globally accessible vaccine for HIV. Prior to IAVI, David was the founding CEO at Anza Therapeutics, a biotechnology start-up developing a novel microbial vaccine platform to induce cellular immune responses to fight or prevent diseases such as cancer, hepatitis C, malaria and tuberculosis. He is also a co-inventor on over twenty-five patents. He received his undergraduate degree from Harvard College and his PhD in chemistry from the University of California, Berkeley. Dr Cook is presently Executive Vice President of R&D, Chief Scientific Officer with Seres Therapeutics, Inc.. Presentation Topic: “The role of the microbiome in resisting
C. difficile infection and the mechanism of Ecobiotic drugs.”

Julie Gubb, PhD, CIC,   has worked in the field of Infection Prevention in varying roles at healthcare facilities in multiple states for more than two decades. After graduating from the University of Detroit Mercy with a degree in Medical Technology, she began her career as Senior Clinical Microbiologist at an acute care hospital in Detroit, Michigan, where she developed an interest in Infection Control while managing the activities of a full-service microbiology laboratory. She was the Director of Infection Control at Mount Clemens Regional Medical Center in Michigan, and has also held positions in Infection Prevention at healthcare facilities in California and Nevada. As a Senior Infection Preventionist for Xenex, Julie works closely with hospitals throughout the United States to understand their infection prevention goals and develop strategies for attaining those goals. As an active member of the national organization Association for Professionals in Infection Control & Epidemiology (APIC), she has maintained Board Certification in Infection Control and Epidemiology since 1993 and speaks frequently at APIC chapter meetings.
Presentation Topic: Stand Up for Cleanliness / Enhanced Room Disinfection

Dr. Patricia J. Freda Pietrobon, PhD: Associate Vice President, R&D,
Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines. Patricia began her career in diagnostic assay development with a focus on validation and quality alignment to regulatory requirements and GXPs. Patricia has been with Sanofi Pasteur for over 25 years and has contributed to the development and licensure of new bacterial & viral vaccines for pediatric & adult populations worldwide.

Barley Chironda, Manager of Infection Prevention and Control (IPAC) and Medical Device Reprocessing Device at St. Joseph Health Centre in Toronto, Canada. He is certified in Infection prevention and control (CIC TM) and has worked extensively as an Infection Preventionist. Barely has been an integral to the successful decline in Clostridium difficile infections through implementing innovative technology and quality improvement behavioral changes.   Barley’s presentation will show a behind the scenes account of the C. diff. management from the healthcare facilities perspective while providing a call to action.

Dr. Martha Clokie, PhD, Leicester UK, Professor in Microbiology.  Dr. Cloakie’s research focuses on phages that infect bacterial pathogens of medical relevance and  has published 41 papers in this area. Her major focus has been on Clostridium difficile where she has  isolated a large phage collection. In vitro and in vivo data has shown that the viruses have therapeutic potential. A patent has been filed  on these phages and  working with AmpliPhi to develop a product. Dr. Cloakie  has regular contact with the BBC and other media to talk about her work, and other phage projects, and has consulted with Science museum, London and Eden Project, UK to advise on bacteriophage displays.

Lee Jones, Founder, President and CEO of Rebiotix Inc, has over thirty years of experience in the medical technology industry in large and small companies and academia. Most recently Lee was Chief Administrative Officer of the Schulze Diabetes Institute at the University of Minnesota, Minneapolis, MN and is the former president and chief executive officer of Inlet Medical. Inlet Medical was sold to Cooper Surgical in 2006. Lee will introduce Rebiotix Inc.,  a biotechnology company founded in 2011 in Roseville, MN to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome The company is developing an entirely new kind of biological drug designed to reverse pathogenic processes responsible for disease through the transplantation of live human-derived microbes into a sick person’s intestinal tract.
Presentation Topic:  Blazing a Trail with the Gut Microbiome

Professor Nancy Sheridan,   a C. diff. Survivor and  Associate Professor at the Fashion Institute of Technology and a winner of the prestigious SUNY Chancellor’s Award for Excellence in Teaching. Professor Sheridan will share her personal experience being treated for a painful and extended journey with a C. diff. infection (CDI).  Professor Sheridan has been teaching since fall 2000 in the Fashion Merchandising Management Department within the School of Business and Technology. For the past seven years, she has also taught at the University of Pennsylvania, Wharton Business School to undergraduate and MBA students.

Dr Mel Thomson, PhD,  completed her Honors degree in microbiology and immunology at the University of Melbourne . She then immigrated to the UK where she worked on various projects as diverse as allergy and cancer before undertaking further studies. She completed a Masters of Research in functional genomics before reading for a PhD in microbial genetic regulation in Neisseria species, both at University of York, UK. After the award of her PhD, Dr Thomson became interested the host-pathogen interactions at the Leeds Institute of Molecular Medicine, UK.  Dr Thomson returned to Australia in 2011 to start her own research group studying host-pathogen interactions in the GI tract, at Deakin Medical School. A passionate science communicator, and has recently become a national ‘torch bearer’ for the concept of crowd funding academic research, which a track record of three successful ‘Pozible’ crowd funding campaigns, ‘Mighty Maggots’, ‘Hips 4 Hipsters’ and ‘No more Poo Taboo’
Presentation Topic: All that glitters is C.diff awareness gold and Crowdfunding: The ‘No more poo taboo’ animation”

Dr Rahma Wehelie – LifeClean International AB – Sweden; LifeClean International AB is a Swedish company with an international orientation that conducts research, development, and production in the spore, bacteria, and virus eliminating industry. LifeClean was established in 2013 after many years of research and the headquarter lies in Uddevalla, Sweden.
Presentation Topic: Dr Wehelie will be discussing LifeClean’s research, development and production eliminating Clostridium difficile, Norovirus, and other multidrug-resistant bacteria

Dr. Klaus Gottlieb, MD, FACG,Synthetic Biologics, Inc.,Vice President, Clinical;Regulatory Affairs   Dr. Gottlieb is an experienced board-certified internist and gastroenterologist with a strong clinical science, business and drug development background. He joined Synthetic Biologics after serving as Senior Medical Director-Therapeutic Strategy Lead Gastroenterology of Quintiles, a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services. At Quintiles, Dr. Gottlieb served as Global Medical Advisor for three separate large Phase 3 inflammatory bowel disease (IBD) trials and provided significant input on the shaping, design and evaluation of numerous IBD and other gastrointestinal (GI) clinical trials throughout all stages of development programs. Prior to joining Quintiles in 2013, he was with the FDA in Silver Spring, MD as a Senior Clinical Reviewer for the Division of Gastroenterology and Inborn Errors Products. Widely published, his academic contributions have been recognized by an appointment as Professor of Medicine (Clinical) at George Washington University and the following elected fellowships: Fellow American College of Physicians, Fellow American College of Gastroenterology, Fellow American Society of Gastrointestinal Endoscopy.  Presentation Topic: Protecting the Gut Microbiome

For additional information contact the C Diff Foundation: (919) 201-1512 or
info@cdifffoundation.org

To Register and obtain tickets, please click on the following link

We would like to sincerely thank the following Exclusive and Supporting Corporate Sponsors for their continued support  and joining the Foundation in
Raising C. diff. Awareness worldwide.

  • Enjoy visiting our Exclusive Corporate Sponsors websites by simply clicking on their logos below

This conference is supported through an educational grant from Sanofi Pasteur US

 

This activity has been supported by an independent patient
advocacy grant from Merck & Co., Inc.

Merck’s Phase 3 Studies of Bezlotoxumab, its Investigational Antitoxin to Prevent C. difficile Recurrence Met Primary Endpoint

IN THE NEWS

Merck  known as MSD outside the United States and Canada, announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for
the treatment of C. difficile.

Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

“These results were also demonstrated in patient subgroups known to be at
high risk for C. difficile recurrence.”

Results from the studies were presented for the first time at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, Sept. 17-21.

“Results of these studies showed that a single, one-time infusion of the antitoxin bezlotoxumab given with standard of care C. difficile antibiotic treatment significantly reduced the recurrence of C. difficile infection compared to standard of care alone, and demonstrated this benefit over a 12-week period,” said Dr. Mark Wilcox, Leeds Teaching Hospitals and University of Leeds, U.K., and a lead investigator for the studies. “These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence.”

Bezlotoxumab is not an antibiotic. It is a selective, fully-human, monoclonal antibody designed to
neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to the symptoms of C. difficile enteritis, which include abdominal pain and watery diarrhea.

Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and licensed to Merck in 2009 for development as a potential
therapeutic for C. difficile infection.

“Recurrence is a major challenge with C. difficile infection, and novel approaches are
needed to help prevent the cycle of C. difficile recurrence,” said Dr. Dale Gerding, professor of medicine, Loyola University Chicago Stritch School of Medicine, Maywood, Ill., and a lead investigator for the studies.

About the pivotal Phase 3 studies

Two global, Phase 3, double-blind studies were conducted to evaluate bezlotoxumab, either alone or in combination with actoxumab (a fully human monoclonal antibody against C. difficile toxin A), compared to placebo for the prevention of recurrent C. difficile infection in patients on standard of care antibiotics for a primary or recurrent C. difficile infection. The MODIFY I study (MONOCOLONAL ANTIBODIES FOR C. DIFFICILE THERAPY) enrolled 1452 patients (median age 65 years) in 19 countries and the MODIFY II study enrolled 1203 patients (median age 67 years) in 17 countries. The studies were conducted in both hospital and outpatient settings, and the primary endpoint for each study was evaluated through 12 weeks following study drug administration.

In the MODIFY I study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=403), actoxumab (10 mg/kg) (n=242), the combination of bezlotoxumab and actoxumab (10 mg/kg each) (n=403) or placebo (n=404). The actoxumab arm was stopped for efficacy and safety reasons after an interim analysis. In the MODIFY II study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=407), bezlotoxumab and actoxumab (10 mg/kg each) (n=397) or placebo (n=399).

In both MODIFY I and MODIFY II, the rate of C. difficile infection recurrence through week 12, the primary efficacy endpoint, was significantly lower in the bezlotoxumab arms (17.4%, p=0.0003) and (15.7%; p=0.0003), and the combination bezlotoxumab and actoxumab arms (15.9%, p<0.0001) and (14.9%, p<0.0001), compared to the placebo arms (27.6%) and (25.7%), respectively. In MODIFY I and MODIFY II, 1396 and 1163 patients were evaluated in the full analysis sets, respectively.

In both studies, the rate of C. difficile infection recurrence was lower in the bezlotoxumab arms compared to the placebo arms in patient subgroups known to be at high
risk for C. difficile recurrence, including patients with any prior
episode(s) of C. difficile infection within the previous six months, patients infected with the BI/NAP1/027 strain, patients with severe C. difficile infection (Zar score ≥ 2), patients 65 years of age or older, and patients with compromised immunity. These subpopulation analyses were pre-specified in the protocol for each study.

In the studies, the adverse reaction rates were comparable across the bezlotoxumab and placebo arms. In MODIFY I, the most common adverse reactions through four weeks after infusion (nausea, diarrhea and pyrexia) occurred at similar rates in the bezlotoxumab group (7.4%, 6.7% and 5.6%) and the placebo group (6.5%, 5.0% and 2.8%). In MODIFY II, the most common adverse reactions through four weeks after infusion (nausea, diarrhea and urinary tract infection) occurred at similar rates in the bezlotoxumab group (5.8%, 5.3% and 4.5%) and the placebo group (3.4%, 6.6% and 4.2%). Additionally, rates of serious adverse reactions and deaths assessed through 12 weeks after infusion were comparable across these treatment arms.

Treatment with the combination of bezlotoxumab and actoxumab did not provide added efficacy over bezlotoxumab alone. Furthermore, actoxumab alone provided no benefit in the prevention of C. difficile recurrence compared with placebo. Based on these results, bezlotoxumab alone was selected for the marketing authorization application.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

 

To read the article in its entirety click on the following link:

http://www.businesswire.com/news/home/20150920005053/en/Pivotal-Phase-3-Studies-Bezlotoxumab-Merck%E2%80%99s-Investigational#.VgFWTpftVQs

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Dr. Nicholas Kartsonis Discusses Merck’s History In Infectious Disease and Their Ongoing Research Plus Some Of The Company’s Current Treatments, Including Dificid, To Address C. diff. Infections (CDI)

                What’s new in the C Diff Foundation?

Let us introduce you to the first internet radio talk show dedicated to C. diff. and more……

C. diff. Spores and More”

 

UPCOMING SHOW:  TODAY ~ Tuesday, May 26th: 

 Dr. Nicholas Kartsonis;  Merck Research Laboratories (MRL)

Join us today, Tuesday, May 26th,  as our guest Dr. Nicholas Kartsonis , Associate Vice President of Clinical Research for Infectious Diseases for Merck Research Laboratories (MRL) and Section Head within MRL for antibiotics, antibacterials and cytomegalovirus  shares his time and discusses the past, present, and future contributions of Merck Research Laboratories.  

Dr. Kartsonis joined Merck Research Laboratories in February 2000 and has been actively involved in programs for new antibacterials, antifungals, anti-HIV, anti-CMV, and agents targeted against C. difficile infection.  Most recently, he has led the efforts to ensure the integration of the Cubist Pharmaceuticals clinical research portfolio within Merck. 

 Dr. Kartsonis will provide an overview of Merck’s current efforts to address the worldwide public health crisis posed by antimicrobial resistance, as well as the company’s history in infectious disease and antimicrobial stewardship. In addition, he will talk about the company’s current treatment for C. difficile and ongoing research efforts to address C. difficile infections (CDI).

http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

We invite you to join us in listening to this exciting, new internet talk show that broadcasts live every Tuesday at the following times:

 Click Image Above to Listen to Archived Shows

 


PT 11a,  MT 12p, CT 1p, ET  2 p

 

We are pleased to share C. diff. Spores and More” with you because, as advocates of C. diff., we know how important this cutting-edge new weekly radio show means for our Foundation’s community worldwide.

Hard Facts: Deaths and illnesses are much higher than reports have shown. Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.

Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.
Previous studies indicate that C. diff. has become the most common microbial cause of Healthcare-Associated Infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection. The CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

“This does not include the number of C. diff. infections taking place and being treated in other countries.”  “The  CDF supports hundreds of communities by sharing the CDF mission and    raising C. diff. awareness to healthcare professionals, individuals, patients, families,  and communities working towards a shared goal ~  witnessing a reduction of newly diagnosed            C. diff. cases by 2020 .”   ” The CDF Volunteers are greatly appreciated as they create positive changes sharing their time so generously worldwide aiding in the success of our mission and raising C. diff. awareness.”

C. diff. Spores and More” spotlights world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more.

Through their interviews, the CDF mission will connect, educate, and empower many worldwide.

 

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.

 

Please join us Tuesdays in listening to the educational episodes of C. diff. Spores and More”

View the programs and radio information and access previous episodes available as a podcast by clicking on the link below:

www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

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