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Nymox: Another Look at Enlarged-Prostate Drug

HASBROUCK HEIGHTS, N.J. ( TheStreet) -- Three and a half years ago, I knocked Nymox Pharmaceutical (NYMX) for hyping the prospects for an experimental prostate enlargement drug NX-1207 without divulging much information about the drug or how it was performing in early clinical trials.

"Nymox doesn't pass the smell test," was my verdict on May 12, 2007. That was a good call because Nymox, trading around $6 back then, lost half its value over the next two years and only in the last two months has the stock recovered to the point where it now trades around $7 a share. [Nymox closed Wednesday at $6.89 a share.]

Time passes and stories can change, so Nymox CEO Paul Averback gave an hour of his time recently to update me on the company's progress with NX-1207, which is now in dual phase III studies as a treatment for benign prostatic hyperplasia, or BPH.

The drug: NX-1207 is a "proprietary protein that leads to apoptosis [cell death]," said Averback.

I asked Averback to elaborate because many drugs cause cell death. I wanted him to better explain '1207's structure and what the drug targets or acts upon to initiate cell death.

Averback wouldn't divulge anything more about '1207 or how it works. The drug is "a non-public structure for proprietary reasons… It induces apoptosis in a number of ways that are way beyond what the investing public needs to know," he said.

Why the secrecy? I understand the need to protect trade secrets but most drug companies don't have a problem disclosing information on a drug's composition and its mechanism of action. To say only that '1207 is a protein that kills cells says nothing.

Averback is more open about the way '1207 is administered -- via what is known medically as a "transrectal injection." Translation: A doctor inserts a probe into the man's anus to access the prostate. A needle is then threaded through the probe, through which '1207 is injected directly into the prostate tissue. Sounds frightening, but Averback insists the procedure is performed without anesthesia in a doctor's office and takes only a few minutes. A benefit of '1207 is that patients can be relieved of BPH symptoms for a year or more with a single transrectal injection versus having to take a pill every day, which comes with side effects). Surgery is an option but also carries risks and side effects, says Averback.

The disease: Benign prostatic hyperplasia, or BPH, is known more commonly as an enlarged prostate. The condition affects men as they get older with symptoms that generally include trouble urinating, frequent urination or pain during urination.

Some men find BPH doesn't affect their lifestyle and choose to do nothing about it; others seek out treatment with medications. BPH drugs include Alpha-1 blockers (Flomax, Cardura) which relax the muscles in the prostate and make it easier to urinate; or 5-alpha reductase inhibitors (Proscar, Avodart) which work against male hormones to reduce the size of the prostate. For more severe cases of BPH, prostate surgery is an option.

Nymox is betting that '1207 will be more effective and less bothersome (in terms of side effects) than current BPH pills and surgery. The company also believes that doctors and patients will be attracted to the convenience of treating BPH via injection once a year. This is similar to the approach taken by Amgen (AMGN - Get Report) with its new osteoporosis drug Prolia.

The BPH drug treatment market topped $5 billion in 2009, according to Nymox (Flomax sales alone in 2009 totaled $1.5 billion for Boehringer Ingelheim) although less expensive generic BPH drugs are now available.

Phase II data: Nymox conducted two phase II studies of '1207, results of which were published last year in Expert Opinion by Dr. Neal Shore of the Carolina Urologic Research Center. Shore is a paid consultant to Nymox. The company has also presented '1207 data at regional conferences sponsored by the American Urological Assocation (but never at the AUA annual meeting.)
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