By Jim Shrine

Senior Staff Writer

Analysis from two Phase III trials of InKine Pharmaceuticals Co. Inc.’s Diacol tablets showed they were as effective as the leading purgative agent but were significantly more tolerable and preferred by patients.

InKine, of Blue Bell, Pa., plans to take the data to the FDA later this year, with an eye toward filing a new drug application (NDA) on the drug that would address a $200 million market. InKine’s stock (NASDAQ:INKP), which recently was picked up by at least three analysts, gained 12.5 cents Thursday to close at $1.718.

“It is obvious that the data are very strong and, in our mind, unequivocal in terms of the statistical significance,” Leonard Jacob, the company’s chairman and CEO, told BioWorld Today. “The first step is to try to shepherd this through the FDA,” he said, adding the company already is preparing the NDA.

Diacol, a patented anhydrous sodium phosphate tablet, is designed to be used as a purgative agent prior to colonoscopy, a procedure used to screen for colon cancer. Two identically designed Phase III trials involving more than 800 patients tested Diacol against the leading purgative agent, NuLytely.

The trials showed colon cleansing was the same or even better (though not significantly) for Diacol patients, but they had statistically significant fewer incidences of adverse events – nausea, vomiting and bloating – and strongly preferred that product to the liquid formulation. In each trial, five times as many patients in the NuLytely group were unable to complete the treatment of the prescribed dose.

Jacob said a more desirable agent would result in many more procedures, allowing physicians to detect and then treat causes of the cancer.

“If you do a colonoscopy you can prevent 90 percent of all colon cancers,” he said. “It’s the single most preventable form of cancer. More people die from colon cancer than breast and prostate cancers combined.”

Jacob said all men and women older than 50 should undergo colonoscopies, but the major deterrent is the “terrible-tasting liquids” that cleanse the colon.

“There hasn’t been anything new in this field in about 25 years,” Jacob said. “We think we can encourage more patients to undergo colonoscopy and prevent colon cancer.”

There are 1,000 to 1,500 gastroenterologists practicing in the U.S., Jacob said, and InKine’s plan now is to build a targeted sales force consisting of a senior vice president, two field directors and 10 to 15 salespeople. A look at the numbers showed it made financial sense to go that route rather than license the product out, he said, even though the company is open to other ideas. One objective would be to outlicense the product for the European and Japanese markets in exchange for U.S. rights to market a product to the same end users.

“A number of companies have contacted us,” Jacob said, adding that InKine is in a good position because there are so few “low-risk, low-tech” biopharmaceutical products available now that address a significant market. “We’re listening,” he said, “but we feel good about our ability to market the product.”

Jacob said the U.S. market represents half or more of the $200 million worldwide market, a number that is increasing by 10 percent to 20 percent per year. It could grow even more in coming years with the introduction of “virtual,” CT scan-type techniques to replace the uncomfortable tubes used in the procedure.

InKine would have an obligation to educate people about the importance of the procedure as well as provide product, Jacob said.

“Our IND [investigational new drug application] went in on this product on June 29,” Jacob said. “We completed Phase I through III in less than 10 months. We feel good about the rapid development time. We are very comfortable with the data. It’s a low-risk, low-tech product with a nice series of endpoints that we designed with the FDA. Hopefully that will bear fruit for InKine.”

The company has about $9 million in cash, which should last about 16 months and provide for completion on development of its two lead products, said Robert Apple, InKine’s chief financial officer. The company might seek additional financing to support marketing, he said. InKine has about 22.7 million shares outstanding.

The company’s second product, an oral steroid called CBP-1011, is about midway through testing in a Phase III trial for the treatment of idiopathic thrombocytopenia purpura, a blood platelet disorder. Jacob said InKine also has an interesting thrombospondin technology, which blocks the human hormone of metastases, in the late preclinical stage. n