Tag Archives: C difficile prevention clinical study

Valneva Announces End To Phase II Study For Vaccine Candidate VLA84 – Prevention of C. difficile Infection (CDI)

Valneva SE July 26, 2016 announced the successful completion of its Phase II study for its prophylactic vaccine candidate VLA84 targeting primary prevention of C. difficile infection (CDI), which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide.

Valneva previously announced positive top-line data from the Phase II study at the end of 2015. These initial results, which included data up to Day 56 following initial vaccination, were presented at the American Society of Microbiology’s annual meeting, ASM Microbe 2016, on June 17 in Boston. VLA84 was immunogenic at all doses and formulations tested, in that Immunoglobulin G (IgG) and functional (neutralizing) antibody responses were observed. The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion rate against both toxins A and B and confirmed the favorable safety profile observed in Phase I.

Final Phase II results included the follow-up of study participants until Day 210. This long-term data confirmed the optimal vaccine dose and formulation that had been previously identified (high-dose formulation without adjuvant) with an immunogenicity profile at Day 210 in line with expectations. Long-term safety concerns were not seen in any of the different vaccine doses tested.

Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva, commented, “We are pleased with the positive final data generated in this Phase II trial and believe that our C. difficile candidate has the potential to address a growing unmet medical need. Infections caused by C. difficile are responsible for almost 30 thousand deaths every year in the US alone. There is currently no vaccine on the market that can protect patients and we are determined to find a partner to advance our vaccine candidate further.”

Valneva’s C. difficile Phase II trial was a randomized, placebo-controlled, observer-blind multi-center trial designed to further study and confirm the candidate vaccine’s safety, immunogenicity and proposed doses of immunizations in two different age groups (50 to 64 years of age and 65 years of age and older).

The trial was conducted in Germany and the United States under an Investigational New Drug application (IND) and enrolled 500 volunteers who were randomized in several study groups: low-dose vaccine without adjuvant, high-dose vaccine with or without adjuvant (Aluminium hydroxide), or placebo.

Valneva confirmed Phase III readiness through an independent Scientific Advisory Board (SAB) and is ready to support an end-of Phase II meeting (EOP2 meeting) with the regulatory authorities once the final Phase III design has been agreed with a partner.  As announced previously, Valneva expects to enter into a partnering agreement for this program by year end 2016.

Currently, no vaccine against C. difficile is approved and antibiotic treatment of the established disease has significant limitations with recurrence in approximately 20% of cases. The incidence of nosocomial infections is steadily increasing due to the growing number of medical interventions. Valneva estimates that the total market potential for prophylactic C. difficile products may exceed $1 billion annually

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

http://outbreaknewstoday.com/c-diff-vaccine-candidate-valneva-announces-end-to-phase-ii-study-71382/

Synthetic Biologics SYN-004 Intended for the Prevention of C. diff. Infection (CDI) and Antibiotic-Associated Diarrhea (AAD)

UPDATE:

Synthetic Biologics Announces Further U.S. Patent Successes Covering SYN-004 Intended for the Prevention of C. difficile Infection and Antibiotic-Associated Diarrhea

 

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced today that the U.S. Patent and Trademark Office (USPTO) issued Notices of Allowance for three patent applications which cover composition of matter claims and methods of protecting the gut microbiome from certain beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). These new allowances further strengthen the Company’s novel proprietary candidate, SYN-004, which is also covered by a composition of matter patent in the U.S.

 

 Synthetic Biologics, Inc. www.syntheticbiologics.com

What is SYN-004? 

SYN-004  is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the gut microbiome. C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 35 U.S. and foreign patents and approximately 30 U.S. and foreign patent applications, and carry patent terms that extend from at least 2031 to 2035.

“These new patents will complement our growing SYN-004 patent estate and support our C. difficile prevention program, including two ongoing Phase 2 clinical trials,” said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “We’re on schedule with respect to patient enrollment in our global Phase 2b proof-of-concept clinical trial intended to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower-respiratory tract infection. During the first half of 2016, we also anticipate announcing topline data from the second Phase 2a clinical trial which is evaluating the ability of SYN-004 to degrade IV ceftriaxone in the presence of a proton pump inhibitor.”

About Synthetic Biologics, Inc. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

 

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

C. diff. Spores and More – CdiffRadio – Welcomes Guests; Dr. Guy de Bruyn,MD, Dr. Christian Felter,MD, and Dr. Patricia J. Pietrobon,Ph.D. of Sanofi Pasteur

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Join us on Tuesday, March 1st as we discuss ——-

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense”

Tuesday, March 1st — Live Broadcast Times

10 a.m. Pacific Time,,   11 a.m. Mountain Time,
12 p.m. Central Time,    1 p.m. Eastern Time

We invite you to  listen to the live broadcast and archived programs by clicking on the
Cdiff radio logo displayed below:

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This episode we will introduce  Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is in the midst of its Phase III clinical trial called Cdiffense to study its investigational vaccine to prevent Clostridium difficile infection (CDI).

The trial is now in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic CDI.

The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut. The investigative vaccine ultimately may help prevent a future infection from occurring. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year.

For more information on the Cdiffense trial – Please visit www.Cdiffense.org 

Join Guests: 
Dr. Guy de Bruyn, MD  –  Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Dr. Christian Felter, MD  –  Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine. Dr. Felter has 11 years of experience in medical affairs roles in the US and Europe, covering therapeutic areas including Immunology, Rheumatology, and Infectious Diseases.

Dr. Patricia J. Freda Pietrobon, PhD  – Associate Vice President, Research & Development Sanofi Pasteur 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.

Join us as we introduce Sanofi Pasteur and discuss updates focused on

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense

C. diff. Spores and More™  Global Broadcasting Network –  producing educational programs dedicated to  C. difficile Infections and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

 

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