Updated February 20, 2014

Sanofi Pasteur’s Clinical Vaccine Trial for Prevention of C.diff Now in Phase III Stage

Sanofi Pasteur, one of the world’s largest vaccine manufacturers, is developing a vaccine for prevention of Clostridium difficile.

Because of the unmet medical need regarding this disease, in 2010, The U.S. Food and Drug Administration (FDA) granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The vaccine is now in the Phase III stages of its Clinical Vaccine Trial and is looking for volunteers in several countries to participate in this preventative vaccine trial.

For more information regarding the Cdiffense Cdiff vaccine trial and trial centers, please visit http://www.cdiffense.org

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UPDATED: 27th January 2014

PUNCH™ CD Study Completes Enrollment In A Clinical Trial For The Treatment Of Recurrent Clostridium difficile Infection

This is the first multi-center study of a next-generation fecal transplant

The PUNCH™ CD study, sponsored by Rebiotix Inc., has completed enrollment. This study represents Rebiotix’s progress toward developing and commercializing a new non-antibiotic, therapy to treat patients with recurrent episodes of debilitating and potentially life-threatening Clostridium difficile infection (CDI).

What is CDI? Symptoms of Clostridium difficile infection include profuse watery diarrhea, abdominal pain and tenderness, fever and loss of appetite. The term for the diarrhea resulting from CDI is Clostridium difficile-associated (CDAD).

The purpose of the PUNCH CD study is to assess the safety of RBX2660, an upgraded version of fecal transplant (FT) therapy for the treatment of recurrent Clostridium difficile infection. Secondary objectives of the study include gathering information on the efficacy and cost-effectiveness of the therapy. A total of 40 patients at 13 centers across the United States were enrolled. Now that enrollment is complete, the study will continue until all follow-up data is collected. Rebiotix is currently working on a protocol for a randomized multicenter Phase 3

What is RBX2660? RBX2660 is a preparation of live microbes that is being studied to see if it safely treats recurrent CDI.

Similar microbial treatments have been used in the past, but RBX2660 is the first standardized and commercially prepared next generation fecal transplant therapy for the treatment of recurrent CDI. As such, it represents a milestone in translating knowledge about the human microbiome into a drug for human use.

Why is the PUNCH CD Study Important?

Although clinicians have prepared similar products using a variety of methods to treat recurrent Clostridium difficile infection for many years, the PUNCH CD study is the first time that a standardized commercially manufactured biological drug containing live microbes is being evaluated.

Why Participate in a Clinical Study?

People participate in clinical studies for many reasons. These include having the opportunity to:

· Receive a new, potentially helpful, research treatment before it is available commercially.

· Receive care at a leading healthcare center during the study.

· Help others with a similar condition.

· Help advance medical knowledge.

Where can I Learn More?

Additional information on the PUNCH CD study can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01925417?term=Rebiotix&rank=1

About Rebiotix:

Rebiotix Inc. is a biotechnology company founded to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company has developed a unique biopharmaceutical platform called Microbiota Restoration Therapy (MRT) to restore healthy gut flora through the transplantation of live microorganisms.

Visit Rebiotix on the Web at: www.rebiotix.com

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PUNCH™ CD Study Is Currently Enrolling Patients In A Clinical Trial For The Treatment Of Recurrent Clostridium difficile Infection

Could lead to the development of a new class of drugs based on the human microbiome

Now Enrolling
The PUNCH™ CD study, sponsored by Rebiotix Inc., is now enrolling subjects. This study represents Rebiotix progress toward developing and commercializing a new therapy to treat patients with recurrent episodes of debilitating and potentially life-threatening Clostridium difficile infection (CDI).

Purpose
The purpose of the PUNCH CD study is to assess the safety of RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile-associated diarrhea (CDAD).

What is CDAD?
Symptoms of Clostridium difficile infection include profuse watery diarrhea, abdominal pain and tenderness, fever and loss of appetite. The term for the diarrhea resulting from Clostridium difficile bacteria is CDAD.

What is RBX2660?
RBX2660 is a preparation of live microbes that is being studied to see if it safely treats recurrent CDAD.

Similar microbial treatments have been used in the past, but RBX2660 is the first standardized and commercially prepared microbiota restoration therapy (MRT) for the treatment of recurrent CDAD. As such, it represents a milestone in translating knowledge about the human microbiome into a drug for human use.

Why is the PUNCH CD Study Important?
Although clinicians have prepared similar products using a variety of methods to treat recurrent Clostridium difficile infection for many years, the PUNCH CD study is the first time that a standardized commercially manufactured biological drug containing live microbes is being evaluated.

Study Design
PUNCH CD is an open-label, non-randomized study. That means that all clinicians and patients in the study will know that RBX2660 is being given and that all patients in the study will receive RBX2660. Approximately 40 patients will be enrolled in the study, which will continue until all patients have completed six months of follow-up.

Which Healthcare Centers are Participating?
Approximately 20 centers in the US and Canada are participating in the study.

Who is Eligible to Participate?
In brief, the target patient population is adults (≥ 18 years old) with recurrent CDAD who have had:

• At least two recurrences of CDAD (at least three episodes) and have completed at least two rounds of oral antibiotic therapy.

Or

• Have had at least two episodes of severe CDAD resulting in hospitalization.

Why Participate in a Clinical Study?
People participate in clinical studies for many reasons. These include having the opportunity to:
• Receive a new, potentially helpful, research treatment before it is available commercially.
• Receive care at a leading healthcare center during the study.
• Help others with a similar condition.
• Help advance medical knowledge.

Where can I Learn More?
Additional information on the PUNCH CD study can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01925417?term=Rebiotix&rank=1

About Rebiotix
Rebiotix Inc. is a biotechnology company founded to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company has developed a unique biopharmaceutical platform called Microbiota Restoration Therapy. Lead product RBX2660 is targeted at recurrent Clostridium difficile, a life-threatening largely hospital-acquired infection.

Visit Rebiotix on the Web at http://www.rebiotix.com