By Jim Shrine

Special To BioWorld Today

Despite raising less than $12 million since its founding five years ago, Milkhaus Laboratory Inc. has taken a series of products into clinical trials and, bolstered by strong Phase II study results for its prostate drug, is looking for partners.

Data from the 100-patient, placebo-controlled Phase II trial showed the chorionic gonadotropin (CG) hormone-based agent, HP-4, produced statistically significant relief of benign prostatic hyperplasia (BPH) symptoms.

A similar product, LDI-200, is in a Phase III trial for myelodysplastic syndrome and Phase II studies of prostate cancer and acute myelogenous leukemia. The company said studies of the CG-based products have shown that, at the proper dose, they induce apoptosis by the down-regulation of the oncogene Bcl-2.

Much of the development at Milkhaus stems from work done by founder John McMichael, an immunologist and virologist, in treating cancer and other diseases in cats and dogs. Milkhaus has a veterinary products subsidiary.

"He had done a lot of work with chronic diseases in animals that reflected what he called dysfunction, which means a gene was intact but inappropriately 'on' or 'off,'" said John Glass, Milkhaus' vice president of business development. "He observed cancer cells were stuck at a primitive stage in their evolution. Apoptosis had failed to occur."

Those assumptions were corroborated in laboratory and human studies that started in 1993, Glass said.

Milkhaus is a "virtual" company based in Boxford, Mass., only because that's where Glass has his home office. All 11 Milkhaus employees work from their homes or labs.

With only $11 million cash, the company has submitted four investigational new drug applications and conducted "nine or 10" trials, Glass said. "It's been a very efficient way to operate," he added. "We've taken the results of animal trials employing molecules whose toxicity was already established, and used them at moderate doses in humans, thereby making it less arduous to get FDA approval for early-stage human clinical trials."

Another product, HP-3, is a naturally occurring nucleic-acid-like compound being tested in Phase II trials for three respiratory diseases: cystic fibrosis, chronic bronchitis and chronic obstructive pulmonary disease. Glass won't describe the product fully because, unlike HP-4 and LDI-200, patents haven't been issued.

The peptide-based product 2CVV was in a Phase I/II trial for chronic fatigue syndrome. Although results were encouraging, development was put on hold because of the difficulty in enrolling patients, Glass said. A product not yet in the clinic is CM-3, which Milkhaus expects to develop for cardiomyopathy.

"We would hope the current success we've had in the clinic would lead us to get financing sufficient to take us into the next round of clinical trials," Glass said. "Because our burn rate is so low [$2 million to $3 million per year], it would not take the usual high level of funding."

The company hopes to get a partner or partners in the next few months for HP-4 and LDI-200, as well as HP-3.

The company's financing to date has been through private individuals. As a step toward the public markets, "it would be desirable to have a venture partner to help legitimize the technology and support us in gaining an investment banker to take it public," Glass said. "We think we need two clinical successes to qualify for the public markets."

One success came from the Phase II trial of HP-4 in BPH released last month, Glass said. "We're hopeful by year's end we'll be able to say the same about our respiratory product," he added.

The name Milkhaus comes from the name of the barn in Pennsylvania where McMichael once milked cows and performed some of his original work. Some of the same technology used in developing the human drugs also is being used in the Delanson, N.Y.-based subsidiary, Milkhaus Veterinary Products. *

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