Pipex Pharmaceuticals, Inc. (PP) is a specialty pharmaceutical company focused on developing proprietary, late-stage treatments for central nervous system and autoimmune diseases. The company hopes to complete clinical testing, along with manufacturing and regulatory requirements, to seek marketing authorizations through the filing of new drug applications (NDA) with the FDA and marketing application authorizations with the European Medicines Evaluation Agency.
A key element of Pipex’s strategy is to perform efficient and timely development of their clinical-stage drug candidates through the selection of initial indications that represent high-profile, unmet medical needs. Upon approval, the drug candidate’s scope may be expanded to additional therapeutic applications through additional post-approval clinical trials and supplemental NDA filings. Pipex is focused on a number of drug candidates at varied stages of development.
* Zinthionein is an oral treatment used for dry, age-related macular degeneration (AMD). In its phase II clinical trial, the candidates who were given Zinthionein demonstrated a significant improvement in visual acuity, contrast sensitivity, and photo-recovery times within a 6-month period. Currently there are 10 million Americans with AMD, and another 50 million at risk for developing AMD.
* Trimesta, currently in phase II/III clinical trials, is a once-daily oral treatment used for multiple sclerosis (MS). In earlier tests, female patients demonstrated a 79% decrease in brain lesions in 3 months and a 14% improvement in cognitive function within 6 months. The testing of Trimesta is being supported by a $5 million grant from the Southern California Chapter of the National Multiple Sclerosis Society and the National Institutes of Health.
* Flupirtine is an oral treatment used by fibromyalgia patients. The company has received an IND with the FDA to proceed with a phase II clinical trial, which is on hold awaiting institutional review board approval. The potential use of flupirtine expanded upon early indications that the drug may be applicable for use in patients with diabetic retinopathy, retinitis pigmentosa and dry AMD.
* Oral Tetratioholybate (TTM) is a treatment currently being evaluated for use with Alzheimer’s disease, idiopathic pulmonary fibrosis (IPF), and Huntington’s disease. The company is developing further research to support the further testing of the applicable uses of the oral TTM.
“We intend to continue to advance our products through the clinic and to seek non-dilutive sources of funding for them through either peer reviewed grants as well as continuing our discussions with potential corporate partners,” reflected Nicholas Stergis, CEO of Pipex. “We also continue to make progress in evaluating new in-licensing opportunities of late-stage clinical compounds for unmet medical diseases.”
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