ANN ARBOR ? The MichBio Expo Sept. 29 was the coming out party for a new Michigan biopharmaceutical company that hopes to commercialize research developed by a University of Michigan geneticist that might cure a fatal lung disease that kills 40,000 people in the United States each year ? the same number killed annually by breast cancer.
Pipex Therapeutics is developing new orally available small molecule drug candidates for the treatment of neurologic and fibrotic diseases for which there are currently no FDA-approved therapies.
The company has been built around technology licensed from the University of Michigan and developed by Dr. George Brewer, former chairman of the Department of Human Genetics at the U-M.
Brewer began enrolling patients in clinical tests of the drug, Coprexa, in 1988 as a possible treatment for Wilson?s Disease, a genetic disorder that attacks the central nervous system. Brewer developed clinical data, but had not taken the drug to the FDA for approval. Some 6,000 people in the United States suffer from this disorder.
Winning FDA approval has fallen to Pipex, lead by Steve Kanzer, a CPA, who is chairman and chief executive officer. Kanzer also is chairman and CEO of Accredited Ventures, a venture capital firm specializing in growing start ups in the biotechnology and pharmaceutical industries.
One of Kanzer?s biggest success stories was developing Trisenox, a drug used to treat acute leukemia. Trisenox still holds the record as the fastest drug ever approved by the FDA ? in just 30 months. He sees a similar fast track approach for Coprexa.
?This is just the latest example of how the Michigan environment is able to attract executives to the state of Michigan,?? said MichBio Executive Director Michael Witt. ?We welcome Pipex to the MichBio community and look forward to watching their progress in their clinical trials and supporting them in any way we can.?
Coprexa is nearing completion of a one year phase II clinical animal trial to treat Idiopathic Pulmonary Fibrosis (IDF), a fatal respiratory disease characterized by progressive loss of lung function due to extensive fibrosis of lung tissues. Some 200,000 Americans have Pulmonary Fibrosis, and about 40,000 of them die from it each year.
Pipex, with financial support from the National Institute of Health and the Coalition for Pulmonary Fibrosis, also is planning an additional randomized double blind, placebo-controlled trial of Coprexa in IPF, and if successful, plan to file a Supplemental New Drug Application with the FDA and corresponding international regulatory agency to market Coprexa for IPF.
Some 83,000 patients with IPF currently take an injectable drug called Actimmune at a cost per patient of about $50,000 a year, Kanzer said. The 83,000 patients represent just 5 percent of the total IPF patient market. Kanzer said Coprexa will be easier to take (orally) and less costly, opening up a potential market of nearly 2 million patients.
?We?re hoping the results of our trial will demonstrate an ability to stop the progression of Wilson?s disease,?? Kanzer said. ?But Coprexa has the potential to go well beyond Wilson?s disease. We?ll file for supplemental NDA on the drug to seek marketing approval from the FDA and make medical claims that Coprexa is helpful for IPF. We believe we?re on the ground floor of something that could be tremendous?
In the area of neurologic pain, Pipex also is developing an oral therapy, called Effirma, for the US market for the treatment of fibromyalgia syndrome (FMS), a common centrally mediated pain disorder characterized by chronic diffuse pain and other symptoms that affects some 6 million people, some 90 percent women.
Mark Shreve, CEO, for the Coalition for Pulmonary Fibrosis, said his non-profit contributed grants of nearly $62,000 to help fund two U-M studies, which allowed the U-M to add more patients to its study.
?We find what they?re doing promising in this field of scientific research in TGF-beta and in the animal model for proof of concept,?? Shreve said. ?It?s also encouraging in that very little research is underway for pulmonary fibrosis.?
But Dr. Ganesh Raghu of the University of Washington, described by Shreve as the leading expert on Pulmonary Fibrosis in the country, said Coprexa remains a very experimental agent and will be until human trails are concluded.
?The drug seems to decrease pulmonary fibrosis in animals,?? Raghu said. ?But animal data is animal data and whether that works in humans remains to be seen.?
The results, however, were promising enough for Kanzer to move from New York to Ann Arbor to found Pipex, with partner Nicholas Stergis, who serves as Pipex Chief Operating Officer.
?We will create a new drug that hopefully will save tens of thousands of lives each year,?? Kanzer said. ?What drives me is you can make an impact on people?s lives in drug development. In the end, we?ll have patient testimonials with people saying that drug saved my life. It really makes me well up with pride.?
Mike Brennan is Editor and Publisher of Michigan Technology News (www.mitechnews.com), a web portal site that publishes technology and entrepreneurial news about Michigan technology companies and the people that run them. Mitechnews.Com also publishes co branded newsletters with the top technology and entrepreneurial groups in the state, including MichBio.
