Tag Archives: Loyola University Chicago Stritch School of Medicine

Dr Dale Gerding MD Has Retained The Chicago Corporation To Assist In Locating Exclusive Licensee for Patented Non-Toxigenic Clostridium difficile “NTCD” For Prevention and Treatment of C. diff. Infection

IN THE NEWS

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Dale Gerding, MD, an infectious diseases specialist, researcher, professor and hospital epidemiologist, and one of the leading international experts on Clostridium difficile (“C. diff”), has retained The Chicago Corporation to assist him in finding an exclusive licensee for his patented non-toxigenic Clostridium difficile (“NTCD”) technology for the prevention and treatment of Clostridium difficile infection. Dr. Gerding currently owns patents and all rights to the development, manufacturing, regulatory and clinical trial data for NTCD.

The lead pharmaceutical product, NTCD-M3, incorporating this technology has already completed Phase 1 and 2 Clinical Trials, has FDA Fast Track approval, and is expected to be eligible for Breakthrough Therapy Designation by the FDA for a Phase 3 Clinical Trial and to be eligible for Reference Product Exclusivity for 12 years for an approved biologics license application.  The exclusive licensee would be responsible for manufacturing, continuing development, obtaining pivotal trial regulatory approval in the US and Europe, marketing and selling of the pharmaceutical products. Phase 2 trial has shown that Dr. Gerding’s invention and treatment, NTCD-M3, is effective in significantly reducing the recurrence of C. difficile infection from 30 percent for placebo to 5 percent for the most favorable NTCD-M3 dosage.

CDC reports that C. diff, a highly infectious bacterium, is the most common microbial-cause of healthcare associated infections in the U.S. and can cause symptoms ranging from diarrhea to severe colitis to death, particularly in older patients. It occurs after use of antibiotic treatment and in the US affects over half million people a year including recurrences. It results in up to $5.9 billion per year in excess health care costs.  Reducing its occurrence is a national priority for the Centers for Medicare and Medicaid Services.

Dale Gerding, MD, MACP, FIDSA, FSHEA, is the Chief Medical Officer at a clinical stage biotechnology company and currently a Professor of Medicine in the Division of Infectious Diseases at Loyola University Chicago Stritch School of Medicine and Research Physician at Hines Veterans Administration Hospital.  He has been a Merit Review funded research investigator in the VA for over 35 years and is the author of over 300 peer-reviewed journal publications.

The Chicago Corporation is a middle-market investment banking firm that provides corporate finance services including merger and acquisition, capital raising and other financial advice to middle-market companies.

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

http://www.prnewswire.com/news-releases/dale-gerding-md-seeks-licensee-for-non-toxigenic-clostridium-difficile-treatment-and-prevention-technology-300247170.html

C difficile Study And Antibiotic Resistance; The Risks For Infection

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C. diff Study Provides Insight Into Antibiotic Resistance and Risks for Infection

Exposure to specific antibiotics is linked to the development of certain strains of antibiotic-resistant C. difficile, one of the fastest growing bacteria superbugs, according to a new study published by Stuart Johnson, MD, of Loyola University Health System (LUHS), Loyola University Chicago Stritch School of Medicine (SSOM) and the Hines VA Medical Hospital.

“This discovery takes us one step closer to preventing C. diff and supports targeting specific antibiotics for antibiotic stewardship monitoring programs in the setting of high infection rates due to specific strains of C. diff,” said Dr. Johnson, the lead author, who reported the findings of the retrospective C. diff case control study in Antimicrobial Agents and Chemotherapy.

C. diff has been associated with multiple healthcare facility outbreaks and high national rates of C. difficile infection (CDI) since 2001 and now rivals Methicillin-resistant staphylococcus aureus (MRSA) in both frequency and severity.

Several infectious diseases, including MRSA and C. diff, have become resistant to antibiotics.

As a result, the medical community has deliberately reduced the routine practice of prescribing antibiotics for infectious diseases.

There currently is not a highly effective prevention method for C. diff.

“Antibiotic exposure is arguably the most important risk factor for C. difficile infection (CDI),” Johnson wrote.

“We know that antibiotics wipe out beneficial flora in the gut, making patients susceptible to a C. diff infection.

The other role of antibiotics highlighted in our study is that overuse of specific antibiotics may facilitate infection due to C. diff strains that are highly resistant to those antibiotics.”

Dr. Johnson and a team that included his longtime research partner, foremost C. diff expert Dale Gerding, MD, LUHS, SSOM, identified 143 patients with first episode CDI between 2005 and 2007 in one U.S. hospital at a time when increased CDI rates and severity were noted nation-wide.

Of those 103 patients, or 72 percent, were infected with the BI/NAP1/027 C. diff strain, which is highly resistant to fluoroquinolones and macrolides.

Most patients received multiple antibiotics within six weeks of being diagnosed with CDI. Fluoroquinolone and macrolide exposure was more frequent in patients with B1 strains, and the C. difficile bacteria recovered from the stool specimens of these BI-infected patients also showed high-level resistance to these antibiotics.

 

The article, “Fluoroquinolone and Macrolide Exposure Predict Clostridium difficile Infection with the Highly Fluoroquinolone-and Macrolide-Resistant Epidemic C. difficile Strain Bi/NAP1/027,” can be read online. Authors are Jeffrey T. Wieczorkiewicz, Bert K. Lopansri, Adam Cheknis, James R. Osmolski, David W. Hecht, Dale N. Gerding and Stuart Johnson.

Source: Loyola University Health System

 

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

http://www.infectioncontroltoday.com/news/2016/02/c-diff-study-provides-insight-into-antibiotic-resistance-and-risks-for-infection.aspx

Loyola Int’l C. diff. Research, Dr. Dale Gerding, MD Makes Important Breakthrough Towards the Prevention of Recurring C.diff. Infection

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In what is a major step towards the prevention of recurring bouts of Clostridium difficile (C.diff.) infection, an international team led by Dr. Dale Gerding, MD, Hines Veterans Administration (VA) research physician and professor of Medicine at Loyola University Chicago Stritch School of Medicine, has shown that giving spores of non-toxic C.diff. by mouth is effective in stopping repeated bouts of C.diff. infection which occurs in 25-30 percent of patients who suffer an initial episode of diarrhea or colitis.

 

The study is published in the May 5 issue of the Journal of American Medical Association (JAMA) and is the focus of a JAMA-produced video.

“The results of this study are very gratifying because the preclinical laboratory and patient studies were all done through our VA research program supported by the Department of Veterans Affairs Research Service,” says Gerding. “Results of this study confirm findings of earlier studies that showed that if we can establish non-toxic C.diff. as a resident of the gut of the patient, that we can protect the patient from infection by the toxic strains of C.diff..” Viropharma and Shire pharmaceutical companies supported the clinical trials.

These results warrant additional study to confirm that treatment with non-toxic C.diff. spores can reduce recurrent C.diff. infection and prevent a first episode of C.diff. infection in those who are taking any antibiotics and are at high risk of infection, he added.

Gerding and an international team of infectious disease researchers, including those at Loyola University Medical Center (LUMC), randomly assigned 168 adult patients with C.diff. infection who had been treated for their infection with antibiotics to receive doses of 10 thousand or 10 million spores per day of non-toxic C.diff. in liquid form for 7 or 14 days, or to receive an identical placebo. Of those assigned any dose of non-toxic C.diff. , 11 percent experienced a repeat of infection within 42 days compared with 30 percent of those given a placebo, a statistically significant reduction. For the most favorable dose tested, 10 million spores a day for 7 days, the recurrence of C.diff. infection was reduced to 5 percent.

Healthcare-acquired infections (HAI) including a leading HAI, C.diff. causes severe diarrhea and inflammation of the lower bowel or colon, continues to escalate in frequency and severity in the U.S.

According to the Centers for Disease Control and Prevention (CDC) report published in
February 2015, almost 500,000 C.diff. infections occurred in the U.S. in 2011, with 83,000 recurrences and 29,000 deaths within 30 days of diagnosis.  Older adults taking antibiotics and who receive care at medical institutions have a higher risk at acquiring this infection.

Cheryl O’Riordan, who has had repeated bouts of C.diff. infection, said having C.diff. made her visit the bathroom on an average of 10 times per day. “Before receiving effective treatment, I was unable to leave the house,” says the active cyclist, skier and hiker. O’Riordan went into remission after being treated successfully at LUMC. “I am back cycling more than 3 miles every day and have several major adventure trips planned.”

Gerding, who has published more than 135 studies on C.diff. is considered one of the leading international experts on C.diff..

Stuart Johnson, MD, infectious disease specialist at LUMC, is also the director of research at Hines VA hospital. Together Gerding and Johnson have partnered on C.diff. research for almost three decades, involving many LUMC patients.

“The study offers real hope for those debilitated by recurring bouts of C.diff.,” says Johnson “This study represents a novel and potentially highly effective bacteriotherapy approach to restoring colonization resistance against toxic strains of C.diff. in these patients,” he adds.

Loyola University Health System is recognized internationally as a leader in infection control and prevention.

LUMC is one of a few select hospitals who invest in universal screening of all inpatients for MRSA. Loyola was one of the first institutions to require all staff to have mandatory flu shots as a condition of employment. Loyola was one of several academic hospitals that participated in this recent benchmark international study.

 

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

http://www.eurekalert.org/pub_releases/2015-05/luhs-lso050115.php