TORONTO -- Allelix Biopharmaceuticals Inc. is planning clinicaltrials of a recombinant form of natural parathyroid hormone(PTH) to treat heart attacks.
Allelix of Toronto aims to file investigational new drugapplications (INDs) in the United States and Canada next springon the cardiac application, David Matthews, Allelix's director offinance, told BioWorld on Tuesday. The company is alreadyinvestigating PTH and PTH analogs it has developed as apotential treatments of osteoporosis. PTH helps regulatecalcium to body tissue.
John Dietrich, Allelix's vice president of research and clinicaldevelopment, said the company is confident that PTH showsstrong interaction with cell receptors. "What it's doingintracellularly, we are not sure yet," he said.
The company anticipates that the drug might be effective incombination with existing thrombolytics, such as tissueplasminogen activator (t-PA) or streptokinase, Dietrich said.
A Phase I trial might include up to 50 healthy subjects andtake about four months, Dietrich said. Phase II trials wouldlikely include between 50 and 100 participants and take ninemonths. With positive results, Allelix believes it might file anew drug application (NDA) in about three years.
Allelix plans to take cardiac applications of PTH through PhaseII clinical trials, Matthews said. "We would eventually look formarketing partners down the road." Allelix is working in acollaboration with Glaxo for applications of PTH in treatingosteoporosis.
Allelix has filed patent applications to the natural PTH andseveral analogs. It started exploring potential cardiacapplications of PTH about one year ago and has been aided byPeter Pang, a company consultant and University of Albertafaculty member, who has developed assays to PTH analogs. Thecompany is conducting animal tests of PTH at the Ottawa HeartInstitute, but data from those tests are too early to disclose,Dietrich said.
Allelix has signed a contract with Cetus V.V. of Amsterdam, aunit of Chiron Corp. of Emeryville, Calif., to supply sufficienthuman grade recombinant PTH for conduct Phase I and IIclinical trials until Allelix completes its own manufacturingfacility.
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