Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Pathogenesis(pgns) -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (129)	1/12/1999 11:45:00 AM
From: Mel Spivak	Respond to of 228

PGNS Release ..stock down 5 today on abandonment of TB study: Tuesday January 12, 8:09 am Eastern Time Company Press Release SOURCE: PathoGenesis Corp. Pathogenesis Corp. to Update Investors At Hambrecht & Quist Healthcare Conference SAN FRANCISCO, Jan. 12 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq: PGNS - news) is expected to update investors on its international expansion plans and clinical trial results in a presentation today at the Hambrecht & Quist Healthcare Conference. Chief Executive Officer Wilbur H. Gantz is expected to announce: -- PathoGenesis expects to add seven salespeople in the U.S., four in Canada and four in the U.K. in the first quarter of 1999, as the company continues to broaden its sales and marketing of TOBI® (tobramycin solution for inhalation) for cystic fibrosis patients. The drug was approved in the U.S. in December 1997. Applications for approval were filed in Canada in March 1998 and in the U.K. in August 1998. -- An application for regulatory approval of TOBI in Australia has been filed. TOBI is one of the first drugs to be classified as an orphan drug in Australia, which grants it a priority review. In addition, an Australian patent has been issued on the TOBI formulation. About 2,500 cystic fibrosis patients live in Australia. -- Gantz said he was very excited about the results of the company's double-blind, placebo-controlled, randomized Phase II clinical trial of TOBI in bronchiectasis, a form of severe chronic bronchitis. Bacterial levels in the sputum decreased more than 99.999 percent on average in the TOBI treatment group at 28 days, compared to no change on average in the placebo group. This difference was statistically significant. The percent of patients with at least one adverse experience was comparable between the two treatment groups. The TOBI and placebo groups were comparable at baseline in respect to age, gender, and disease severity. The strength of these results opens the possibility of doing a clinical trial of TOBI in a broader indication, chronic bronchitis. -- The Phase II results from the clinical trial of an oral drug, rifalazil (PA-1648) for tuberculosis, showed that rifalazil was well-tolerated. However, there was an insufficient number of patients in each arm of the trial to provide a conclusive indication of efficacy. The company has decided not to continue the clinical trials of rifalazil at this time, but rather to devote these clinical resources to its inhaled antibiotic program. In addition to the just-concluded Phase II clinical trial for TOBI in bronchiectasis, the company is now in a Phase II clinical trial of TOBI for tuberculosis. PathoGenesis has two additional aerosolized drug candidates in preclinical testing. -- PathoGenesis has received a $1.5 million grant from the Cystic Fibrosis Foundation under its new Therapeutics Development Grants Program. The grant will help support the preclinical and clinical development of PA-1420 (polymyxin E1), a broad-spectrum gram-negative antibiotic designed to be administered by aerosol. Seattle-based PathoGenesis Corp. is a pharmaceutical company that develops drugs to treat chronic infectious diseases -- lung infections, in particular -- where there is a significant need for improved therapy. The company markets TOBI, an inhaled antibiotic, in the U.S. for management of cystic fibrosis patients with Pseudomonas aeruginosa. In addition, PathoGenesis is developing other drug candidates to treat serious chronic lung infections, including those common in cystic fibrosis, bronchiectasis and tuberculosis patients. PathoGenesis' stock is traded on the Nasdaq National Market System under the symbol PGNS. The company's Web site is located at pathogenesis.com. Note: This news release contains ''forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to known and unknown risks, uncertainties or other factors that may cause the company's actual results to be materially different from historical results or any results expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to the fact that PathoGenesis began commercial operations only recently, its dependence on TOBI, third party reimbursement and product pricing, government regulation, drug development and clinical trials, competition and alternative therapies, and other factors described in PathoGenesis' filings with the Securities and Exchange Commission. SOURCE: PathoGenesis Corp.