Repros Announces Additional Results From ZA-300 Six Month Study Of Androxal

(RTTNews) - Repros Therapeutics Inc. (RPRX) announced additional results from its ZA-300 six month study of Androxal in men with secondary hypogonadism.

Literature suggested that secondary hypogonadism is strongly linked to obesity and a variety of maladies that accompany the metabolic syndrome. Some of these accompanying disorders include high cholesterol and poor glycemic control as many men affected by secondary hypogonadism either have or are candidates for cardiovascular disease and/or type 2 diabetes.

The company said it does not intend to suggest that Androxal would represent a treatment for cholesterol or glycemic disorders, but would provide synergistic benefit with either life style changes or medications to improve these measurements.

There were no new safety issues identified, no deaths, no significant cardiovascular findings and, the Company believes there were no significant eye findings. The majority of the recorded AE's were deemed mild to moderate in intensity. The most common AE's were related to upper respiratory tract infections (11.6%), but the study was conducted during the cold, flu and allergy season. Other AE's of note included headache (6.6%), muscle spasms (4%), and fatigue (2.8%). Transient blurred vision was noted in 1.4% but changes in visual acuity were noted as an adverse event in only 0.2%. These findings are in line with expectations given the average age of the subjects (approximately 49 years).

There were two previously described cases of venous thromboembolisms (VTE). One severe case which developed on treatment was in a subject with multiple risk factors and emerged after his hematocrit levels increased above 54%.

The other milder case of deep venous thrombosis (DVT) developed early during treatment. The subject was enrolled after previous T use. At entry his hematocrit was 56%. The subject remained in the study without subsequent relapse. At the end of the study his hematocrit was 43.1%.

The company noted that it has installed a measure in all of its ongoing studies to excuse subjects if they exhibit a confirmed hematocrit above 54%. In previous Repros studies that incorporated a positive hormone replacement control arm, hematocrit elevations were greater in the T replacement arm as was the incidence of observations of > 54%. The currently enrolling studies ZA-304 and ZA-305 will be assessing these changes for both a T replacement gel and Androxal.