Exciting News of New CPPS Treatment

[Adam Boyd]

Milkhaus Laboratories published this press release a couple of weeks ago regarding their investigational treatment for CPPS. There are a couple of points worth noting that aren't included below.

1)The study was designed and conducted by Dr. Rodney Anderson at Stanford University.

2)While there was no placebo group, there was a 4 week placebo run-in, making it highly unlikely that the results were due to a placebo effect.

3)The drug, ML-04, is an orally available form of Human Chorionic Gonadotropin. While this medication is still in clinical trials and won't be on the market for a couple of years, an injectable form of HcG is currently marketed as a fertility treatment.

I'm not sure what the mechanism of action is and the sample size is small, but the level of efficacy observed in this trial was quite remarkable relative to existing treatments for CPPS. See the press release below:

Milkhaus Laboratory Demonstrates Efficacy of New Product for Chronic Prostatitis

March 13, 2003 — Milkhaus Laboratory, Inc., a clinical-stage pharmaceutical company, today announced the final results of a Phase IIA clinical trial of its product, ML-04, for the treatment of chronic prostatitis. The trial was conducted at the Stanford University School of Medicine and preliminary results were reported in late 2002.

These results demonstrate the efficacy of ML-04 for the treatment of chronic, non-bacterial prostatitis. The NIH Chronic Prostatitis Symptom Index ("CPSI") was the primary endpoint, a validated index that measures pain, urinary symptoms and quality of life. Patients improved rapidly in the first four weeks of treatment, and by week 12 showed an average reduction of more than 11 points from a baseline CPSI value of 24 points, an improvement of approximately 60%.

"While the number of patients was limited to 16 in this open-label trial, the results were unequivocal in showing the benefit of ML-04 in reducing pain and other symptoms of this disease. No drug-related adverse events were reported," said Dr. John McLane, Vice President of Clinical and Regulatory Affairs for Milkhaus. "When the treatment period was over, symptoms began to return. However, when ML-04 was once again administered, most patients improved markedly," he added.

"In an earlier Phase IIA clinical trial of this product for treating benign prostatic hyperplasia ("BPH"), ML-04 showed both safety and efficacy comparable or superior to products already on the market. Our results were so encouraging that a larger Phase IIB trial for BPH was initiated. Enrollment for this study will be completed in a few weeks. Combined with the large patient population suffering with prostatitis, for which there is no approved therapeutic agent available, the potential for ML-04 in the urological market is very large," said John Glass, Vice President for Business Development. "We are actively engaged in discussions to partner ML-04 for both BPH and chronic prostatitis indications as a package," he added.

[webslave]

I'd very much like to know what the drug's actual chemical composition is and how it's supposed to work. Until then, and until we have some independent corroborating research, we have to take this with a pinch of salt. But it looks promising!:thumbup:

[Adam Boyd]

I'd very much like to know what the drug's actual chemical composition is and how it's supposed to work. Until then, and until we have some independent corroborating research, we have to take this with a pinch of salt. But it looks promising!

I agree. The results are very preliminary.

The drug is a synthetic form of the naturally occurring hormone, Human Chorionic Gonadotropin. Milkhaus states on their site that it has anti-inflammatory and cell-regulatory actions on the prostate. I search medline, and I only came up with a couple of papers that suggest that HcG has anti-inflammatory properties. Interestingly, HcG levels peak in women during pregnancy, which has led some to believe that it has a role in the amelioration of inflammatory disease that is often observed during pregnancy.


HcG also raises testosterone levels, which makes me wonder if the patients treated in the study were a select group with endocrine abnormalities. If that were the case, the results couldn't be generalized to most chronic prostatitis / chronic pelvic pain syndrome patients. Unfortunately, there isn't a lot of information on their site or in their press releases.

In any event, the drug is scheduled to enter phase III trials for BPH this year, which means it could be on the market for that indication within the next few years. Once it becomes publicly available, it will only be a matter of time before its true value in treating chronic prostatitis / chronic pelvic pain syndrome will be revealed.

[dshoskes]

2)While there was no placebo group, there was a 4 week placebo run-in, making it highly unlikely that the results were due to a placebo effect.

Unfortunately, not true. Many studies with placebo run in that are also placebo controlled see an equal magnitude in improvement between treatment and placebo groups.

This is no comment yea or nay on the ultimate efficacy of this treatment, but many, many drugs look promising at the phase IIA stage that crash and burn at the phase III stage.

[Adam Boyd]

Unfortunately, not true. Many studies with placebo run in that are also placebo controlled see an equal magnitude in improvement between treatment and placebo groups.

This is no comment yea or nay on the ultimate efficacy of this treatment, but many, many drugs look promising at the phase IIA stage that crash and burn at the phase III stage.

In looking at the data, there was a mild improvement during the placebo phase, followed by a marked and progressive improvement during the 12 weeks of active treatment. An improvement of the magnitude seen here has never been observed in the placebo arm of any prior studies in this condition. With that said, however, you make a good point – it’s impossible to draw conclusions based on such a small study. I still find these results encouraging, nonetheless, considering the paucity of treatments currently available.