UPDATE 1-Repros' testosterone drug shows promise, shares soar

* Says hopes to meet with FDA on prospects for drug

* Shares up as much as 179 pct

(Adds analyst comment, details; updates share movement)

By Jennifer Robin Raj

BANGALORE, Oct 7 (Reuters) - Repros Therapeutics Inc (RPRX.O) said its experimental drug Androxal restored normal sperm count while increasing testosterone levels in an exploratory study, sending its shares up nearly three-fold.

The small study involved men with secondary hypogonadism who were receiving testosterone replacement treatment. Secondary hypogonadism is a state in which the male hormone testosterone goes below the normal range.

"This is a really small study and it only worked in seven men out of the 16 that they tested in. So a very small data stat," said analyst Kimberly Lee at Wedbush PacGrow LifeSciences, adding that the market was overreacting. "It concerns me that in the men who were in the higher dose group the testosterone level remained below normal. You would think that as the dose escalates, it would work even better in higher doses but this is not the case," said Lee, who has an "underperform" rating on the stock.

The company said it hopes to submit a request for a meeting with the U.S. Food and Drug Administration to determine whether the agency deems these observations to be clinically relevant and whether a development program can be designed to confirm the findings of this exploratory study.

The company had previously tried to pursue a hypogonadism label for the drug but the FDA and the company were not able to agree on its clinical path based on a meeting in October 2007.

"So now the company is coming back and saying maybe they can get a hypogonadism label, which the FDA already said they could not do. So, I don't they think they will be able to get a label for hypogonadism," Lee said.

The exploratory study was designed to compare Androxal to Testim, Auxilium Pharmaceuticals Inc's (AUXL.O) gel to treat low testosterone.

Overall, treatment with Androxal was well tolerated in this study, with few side effects being reported, Repros said.

Last month, the company said U.S. health regulators asked for additional data on its lead drug Proellex, to resolve the clinical hold placed on it. [ID:nBNG404732]

Shares of the company were up $1.15 at $2.05 in morning trade on Nasdaq. They had touched a high of $2.48 earlier in the session. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Aradhana Aravindan)