By Randall Osborne
To move forward with its development of Trovert, a growth hormone antagonist for treating acromegaly, Sensus Drug Development Corp. raised $23.4 million in private equity financing.
The money is enough to operate Austin-based Sensus "well into 1999," said John Scarlett, president and CEO. At the end of next year, Sensus hopes to file a new drug application for Trovert with the FDA.
Upcoming trials will test Trovert against diabetes and cancer, Scarlett said.
Acromegaly, which affects about 400,000 people worldwide, is caused by increased secretion of growth hormone as a result of a tumor of the pituitary gland. The condition is characterized by enlarged hands, feet and facial bones. Also affected are the heart and other internal organs, and complications can include cardiovascular disease, high blood pressure, arthritis and diabetes.
Results from a Phase II/III study of 45 acromegaly patients will be ready by the end of next month, Scarlett said. Subjects in the study were given two dose levels of Trovert and a placebo. Another pivotal study will follow.
Sensus, founded in 1994, chose to develop Trovert against acromegaly first because of the incentives offered by its orphan drug status with the FDA, and because acromegaly patients make up a well-defined population treated mainly in academic medical centers.
"The existing products don't work in many of the patients, and these patients suffer a lot," Scarlett said.
Under way at the University of California, San Diego, is a pilot Phase II study of Trovert with Type II diabetic patients. The study is examining the growth hormone antagonist's effect on insulin sensitivity. A study of diabetes-related retinopathy will begin in January, and a third study will investigate diabetes-related kidney disease. Also next year, Sensus will begin clinical studies of Trovert for breast and prostate cancer.
In the equity financing, NationsBanc Montgomery Securities, of San Francisco, served as the placement agent. The lead investor was Ross Financial Corp., of Lawrenceville, N.J. Other investors included The Goldman Sachs Group L.P., of New York, and Javelin Capital Fund L.P., of Birmingham, Ala. *