TGV-Inhalonix, Inc., a New York-based pharmaceutical company, recently announced that it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration (FDA) for its novel antibiotic Mul-1867, which shows promise in treating drug-resistant bacterial pulmonary infections in patients with cystic fibrosis.
“Chronic pulmonary infections lead to progressive decline in lung function and eventually respiratory failure in patients with cystic fibrosis.” said Dr. Victor Tetz, chief scientific advisor at TGV-Inhalonix.
“Preclinical and clinical studies have shown that Mul-1687 holds promise as a treatment for life-threatening pulmonary infections from Pseudomonas aeruginosa, Burkholderia cepacia complex, and other bacteria,” said Dr. George Tetz, drug development advisor, at TGV-Inhalonix. “We believe our research has unlocked a key for slowing the growth of these potentially fatal antibiotic-resistant pathogens.”
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. According to the Cystic Fibrosis Foundation, the median predicted survival age in persons with cystic fibrosis in the United States is 39.3 years, and there is an unmet need of improved treatment of antibiotic resistant pulmonary infections in this population.
MWelborn Group, LLC, a U.S.-based regulatory consulting firm, provided assistance in preparing the Orphan Drug Designation application.
While the orphan status is reserved for pharmaceuticals that treat rare conditions, TGV believes Mul-1867’s unique mechanism also offers a broader potential for the treatment of numerous bacterial, fungal and viral respiratory tract infections, including COPD, which according to the World Health Organization is the fourth-leading cause of death in the United States. The COPD and mucosal infections drug market size in the United States is estimated at $18B.
TGV recently presented the study results on MUL-1867 at America’s largest microbiology conferences – ASM-2015 and ICAAC-2015. The first article about the novel compound was recently published in the Antimicrobial Resistance and Infection Controljournal.
“Taken together, our data suggested that Mul-1867 is a promising novel antimicrobial agent that has potent broad-spectrum antibacterial activity against clinically important microorganisms,” said Prof. Dr. Michael Cynamon, an infectious disease specialist at the Veterans Affairs Medical Center in Syracuse, New York, and a member of TGV’s advisory board.
TGV- Inhalonix is a New York-based research and development pharmaceutical company that provides a broad range of innovative products that are developed, manufactured and marketed worldwide by TGV-Laboratories Group of Companies. Mul-1867 was discovered as the result of years of research by Victor and George Tetz using a new concept they developed called Pangenome ( http://www.ncbi.nlm.nih.gov/pubmed/15990697). This concept acts like a guide that helps mark new therapeutic targets for drugs.
“As the result of applying the Pangenome concept to this promising infection-fighting agent, we have also developed drug candidates to treat other currently untreatable diseases, including graft-versus-host disease and neurodegenerative disorders,” said Dr. Victor Tetz. Dr. Tetz is research and development leader at TGV and a seasoned international researcher with dozens of international patents for breakthrough drugs. Pangenome is just one of the tools utilized by TGV in finding unique solutions aimed at treatment of incurable diseases.
The research of the TGV-Laboratories Group of Companies is focused on identifying new causes for diseases, studying the content of microbiota and its lifecycles, as well as blueprinting and creating small molecules and recombinant proteins.
About TGV-Laboratories Group of Companies.
TGV-Laboratories Group of Companies. is a research-based pharmaceutical company headquartered in New York that provides a broad range of innovative products to treat currently untreatable infectious, autoimmune and neurodegenerative diseases. TGV operates under two divisions: the Division of Drug Discovery & Development and the Division of Medical & Industrial Microbiology. For more information, visit http://tgv-labs.com.