Repros Therapeutics Inc. (RPRX: Quote) was trading around $4 when it was profiled on our site in April of this year. The stock, which has enjoyed a smooth ride since then, set a new 52-week high of $15.80 on September 14, before closing the day's trading at $15.28.
Last week, the company enrolled the first subjects in a trial, dubbed ZA-301, the first of two pivotal studies of Androxal for secondary hypogonadism. The second phase III study, ZA-302, will begin enrollment after the completion of enrollment in the ZA-301 study. Both the studies are identical, and are being conducted under a Special Protocol Assessment granted by the FDA.
The results from the first study - ZA-30, are expected to be available as early as the second quarter of 2013. If all goes well as planned, Repros believes that it can submit the NDA for Androxal for the treatment of male secondary hypogonadism during the first half of 2014.
Secondary hypogonadism, which is one of the primary causes of male infertility, is associated with low levels of testosterone. It is estimated that 13 million men in the U.S. experience low levels of testosterone.
The leading approved therapy for treatment of low testosterone is AndroGel, a testosterone replacement cream, marketed by Abbott Laboratories (ABT). Some of the other approved testosterone replacement therapies are Testim, a topical gel, currently marketed by Auxilium Pharmaceuticals Inc. (AUXL), and AndroDerm, a transdermal patch, marketed by Watson Pharmaceuticals Inc. (WPI).
According to IMS Health, the marketed treatments for low testosterone in the U.S. logged sales of over $1.6 billion in 2011.
Androxal has an edge over the approved testosterone replacement therapies since this oral drug candidate not only treats the cause of secondary hypogonadism, which is inadequate pituitary hormones, but also restores normal testicular function, according to Repros. Even though, the currently marketed testosterone treatments can restore serum testosterone levels, they do not restore testicular function.
Another drug candidate in Repros' pipeline is Proellex for the treatment of endometriosis and uterine fibroids.
Endometriosis is a condition in which the tissue that forms the lining of the uterus grows in places in the body other than the uterus, like ovaries, fallopian tubes, bladder or rectum. It is estimated that over 170 million women worldwide and more than 7 million women in the U.S. suffer from endometriosis. Endometriosis can cause infertility and complicate pregnancy.
Uterine fibroids are benign tumors that are formed in the uterus, and these tumors occur in up to 50% of all women. Uterine fibroids are associated with abnormal uterine bleeding, pelvic pain and pressure on the bladder and rectum. It is estimated that about 25 million women in the U.S. suffer from uterine fibroids.
Last month, the FDA provided guidance for a phase II study of low dose oral Proellex in the treatment of endometriosis. Once the company submits revised protocol for the trial design to the FDA, it will be reviewed within 30 days, and if it is accepted, the phase II oral administration study of Proellex for endometriosis will commence in the fourth quarter of this year, according to a recent press release.
A phase II vaginal administration study of Proellex for uterine fibroids was commenced in the first quarter of 2012. Results from this study are expected to be reported by the end of this year.
A quick look at the company's balance sheet...
Being a development-stage company, Repros has had significant operating losses since inception in 1987, having accumulated losses of roughly $197.3 million.
In the second quarter ended June 30, 2012, net loss narrowed to $3.1 million or $0.21 per share from $3.7 million or $0.30 per share for the same period in 2011. Total revenues and other income decreased to zero for Q2, 2012 from $1,000 for the same period in the prior year.
Repros ended the second quarter of 2012 with cash of about $9.9 million. Earlier this month, the company raised $23.6 million in a private placement offering.
The company is optimistic that the current level of cash on hand will last up to mid 2014 - sufficient to move Proellex into phase 3 studies for both the uterine fibroid and endometriosis indications in 2013, and for submission of Androxal NDA in 2014.
Repros has thus far hit a 52-week low of $3.34 and a 52-week high of $15.80. RPRX closed Friday's trading at $15.28, down 1.29%. The shares have gained over 258% in the last 6 months. Will the stock rally continue? Stay tuned...
Repros Therapeutics - Fertile Thoughts
by RTT Staff Writer
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