Winnipeg biotechnology company Medicure Inc. announced yesterday it has received preliminary endorsement from U.S. regulators to begin testing a second new drug.

The new drug, called MC-4232, is for use in the treatment of hypertension, or high blood pressure. It is associated with Medicure's main compound, MC-1.

According to company officials, the preliminary response from U.S. regulators is such that the new compound could be in clinical trials by this fall.

"This is a very important event for the company," Medicure CEO Albert Friesen said in a telephone interview from Montreal yesterday. "We have been working on this compound for a number of years and we had been waiting to get the proper assurances from the FDA [the U.S. Food and Drug Administration] before we said anything publicly about it."

The FDA has agreed in principle with Medicure's plan with regard to proposed phase II/III clinical trials. It will not be required to undergo phase I trials, which deal with fundamental safety of the drug, because safety data from the MC-1 phase I trial was sufficient, according to Friesen.

Earlier this year, the company successfully concluded phase II clinical trials on MC-1 which showed it does reduce heart damage following angioplasty. The results demonstrated the cardioprotective effects and safety of MC-1 in high-risk patients undergoing angioplasty. Company officials believe that type of heart tissue injury remains a major inadequately treated area of cardiovascular medicine. Friesen pointed out that the introduction of a new compound that could treat hypertension has some exciting possibilities for a couple of reasons.

"This is a second product for the company and we have other things in the pipeline as well," he said. "This product treats a condition for which there is a very large market for and it will be a lot less expensive to test than other drugs."

The latter factor is based on the fact it is relatively inexpensive to test blood pressure than it is to test other medical conditions. Friesen said the FDA will only require a total of 1,000 to 1,500 patients tested in the phase II/III trials, a lot less than many other drugs would require.

Yesterday Medicure's shares closed up one cent to 90 cents on very heavy trading. At one point yesterday, the shares were trading as high as $1.00.

martin.cash@freepress.mb.ca