IRVINE, Calif., June 3, 2013 -- Monarch Labs and the BioTherapeutics, Education & Research (BTER) Foundation announced today their collaboration to develop two fecal microbiota transplantation (FMT) products. The two groups intend to conduct research in the current good manufacturing practice (CGMP) associated with the screening, transport, processing and storage of FMT material.
Monarch Labs plans to commercialize two FMT products. The first product is a CGMP processing and banking service for autologous FMT transplantation. The second product is Medical Microbiota(TM) a FMT product screened for major pathogens and CGMP processed for allograft transplantation. The BTER Foundation frequently places its trainees with clinical or research organizations. Two interns chose to work at Monarch Labs on the FMT project, where they will play key roles in the development process.
Several investigators have published promising clinical results and reviews on FMT for the treatment of Clostridium difficile infection and other bowel diseases.1,2,3 A clinical study recently published in The New England Journal of Medicine and reported in The New York Times found that "such transplants cured 15 of 16 people who had recurring infections with Clostridium difficile bacteria, whereas antibiotics cured only 3 of 13 and 4 of 13 patients in two comparison groups. The treatment appears to work by restoring the gut's normal balance of bacteria, which fight off C. difficile."4
In an April 25, 2013 letter, the Food and Drug Administration ("FDA") has written that it intends to regulate FMT as a biological drug requiring an Investigational New Drug (IND) application for further clinical testing.5 According to a FDA guidance document, CGMP is required in the manufacture of most investigational new drugs used in phase 1 clinical trials under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).6
Currently, the procedures for obtaining, testing, processing, storage and transport of FMT materials are not standardized, nor optimized. The procedures also do not always follow CGMP, which are essential for ensuring the safety of an investigational new drug.
Monarch Labs has conducted research that suggests the processing of FMT materials could be optimally performed in its existing CGMP facility in such a way as to allow tracking and quality controls that are critical for ensuring patient safety and FDA regulatory compliance. Monarch Labs is the only company in the U.S. allowed by the FDA to manufacture and distribute Medical Maggots(TM), which were cleared for marketing in 2004. Medical Maggots(TM) represent the first living organism allowed by the FDA for marketing as a medical device.
"Because FMT has been used sporadically for the past 50 years, there is a long history of safe and efficacious use. I see many parallels with the use of medicinal maggots, which were ultimately cleared for marketing by the FDA in 2004. However, there is still wide variation in FMT processing, which most likely should be standardized based on outcomes research. Processing is beyond the capabilities of most therapists who want to offer the procedure to their patients. We are open to collaborating with FMT investigators," stated Ron Sherman, MD, Monarch's Co-Founder and one of the Board Members of the BTER Foundation.
"We initiated this product development program after receiving multiple inquiries from health care institutions to supply FMT product. Monarch is seeking to be a controlled supplier of CGMP-processed FMT material. We want to be a leader in providing safe and effective materials for this emerging field of medicine," stated James Kuo, MD, Monarch's Chairman.
(1) van Nood, E, Vrieze, A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. N Engl J Med 2013;368:407-415
(2) Brandt, L. American Journal of Gastroenterology Lecture: Intestinal Microbiota and the Role of Fecal Microbiota Transplant (FMT) in Treatment of C. difficile Infection. Am J Gastroenterol 2013;108:177.
(3) Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat. Rev. Gastroenterol. Hepatol 2012;9, 88
(4) Grady D. When Pills Fail, This, er, Option Provides a Cure, The New York Times. January 17, 2013:A1
(5) Available online at: http://highroadsolution.
(6) FDA "Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies."
About Monarch Labs
Monarch Labs is the leading living medicine company in the United States. We manufacture and distribute Medical Maggots™ (disinfected Phaenicia sericata larvae), a natural and inexpensive wound treatment. Our products have been cleared by the FDA, used by thousands of health care institutions, and reimbursed by major insurance companies. We currently have product development underway on Medical Leeches(TM), Medical Microbiota(TM), and Medical Fish(TM). More information is available at http://www.
About the BTER Foundation
The BTER Foundation is a non-profit, membership-based service organization specializing in public support and professional education in biotherapeutic medicine. In 2013, the BTER Foundation began an Internship Program with training in Clinical Biotherapy, Research, Communications, Grantwriting and Videography. Two of the research interns recently chose to work on FMT at Monarch Labs. More information is available at http://www.