Pacgen completes patient recruitment for Phase I/II trial of novel anti-fungal drug
- Category: Proteins and Peptides
- Published on Friday, 16 March 2007 02:00
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VANCOUVER, Canada | Mar 15, 2007 | Pacgen Biopharmaceuticals Corporation ("Pacgen") (TSX-V: PGA) announced today that it has completed the recruitment of patients in its Phase I/II study of PAC-113, a novel anti-fungal drug, in immunocompromised patients. The Company is on track to report proof of efficacy results from this study early in the second quarter of 2007.
PAC-113 is a peptide-based anti-fungal targeting oral candida infections in immunocompromised patients. The Phase I/II clinical trial of PAC-113 is being conducted at sites in the United States and South Africa and has now successfully recruited over 90 HIV patients. The trial will establish preliminary proof of efficacy for PAC-113 in eliminating clinical signs and symptoms of oral candidiasis, as well as provide additional safety data. The microbiological response of Candida albicans to PAC-113 will also be evaluated.
The Phase I/II study is a head-to-head comparison between PAC-113 mouthrinse and Nystatin oral suspension, with intent to treat oropharyngeal candidiasis. The study is a randomized, examiner-blinded, parallel design clinical trial that includes a 14-day treatment phase, and a 14-day follow-up period, with a day 28 follow-up visit. Subject to positive results from this study, the Company plans to initiate a Phase IIb study in immunocompromised patients, to establish the optimal dose of PAC-113, in the fourth quarter of 2007.
Opportunistic growth of candida occurs in people with defective immune systems, and can be life-threatening if not treated. Candida albicans is the most common fungal pathogen among immune-compromised, hospitalized patients, accounting for roughly 50-60% of all bloodstream fungal isolates. Localized candida infections can cause great discomfort, and if not treated, can spread from the primary site of infection through the blood stream to cause a disseminated infection. Disseminated fungal infections are as sociated with a high mortality rate.
Pacgen is a life sciences company focused on the development of peptide therapeutics for the treatment of infectious and inflammatory diseases. The Company's lead product, PAC-113, is an anti-fungal in a Phase I/II clinical trial. Preliminary efficacy data from this study is expected in the second quarter of 2007. Pacgen also has candidates in an early stage research program. The most advanced of these candidates is a peptide therapeutic, PAC-G31P, which is currently being investigated in preclinical studies for its potential to treat inflammatory diseases such as acute respiratory distress syndrome. For additional information, please visit www.pacgenbiopharm.com.
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Forward looking Statements
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Pacgen's current beliefs as well as assumptions made by and information currently available to Pacgen and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Pacgen in its Final Prospectus dated November 28, 2006, actual events may differ materially from current expectations. Pacgen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For all forward-looking statements, Pacgen claims the safe harbour for forward-looking statements within the meaning of the Private ecurities Legislation Reform.
SOURCE: Pacgen Biopharmaceuticals Corporation