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 : Indications -- diabetes -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (45)	10/7/2002 7:30:15 PM
From: Miljenko Zuanic	Respond to of 278

If it is not drug then it is formulation. Always something? Press Release Source: ConjuChem Inc. ConjuChem Updates Status of Phase I Trial for Diabetes Drug Candidate Monday October 7, 2:16 pm ET MONTREAL, Oct. 7 /CNW/ - ConjuChem Inc. (TSX:CJC - News), a Montreal-based biotechnology company, today announced that results from its Phase I clinical trial for DAC:GLP-1(TM) (CJC-1131), a compound under development for the treatment of Type 2 diabetes, are now expected in the first half of 2003, as a result of the need to manufacture a reformulated clinical batch of the compound in order to complete the trial. Results initially were expected to be ready for late 2002. ADVERTISEMENT "Formulation stability issues such as this one are not uncommon in products during the early stages of clinical development, and are usually related to technical as opposed to product-specific concerns," said Dr. Jean- Paul Castaigne, Vice-President, Development & Chief Scientific Officer of ConjuChem. "Our original formulation was based on our experience with other DAC(TM) compounds, but we have now concluded that additional formulations should be examined before we conclude this trial. We will be in a better position to communicate our progress and timelines later this year." Clinical Trial Design The study is being conducted in two parts, the first in healthy volunteers and the second in Type 2 diabetic patients. The first part of the study evaluates the safety, tolerability and pharmacokinetics of single, ascending doses of CJC-1131 and to establish the dose to be considered as the maximum tolerated dose (MTD) in healthy volunteers. The second part of the study evaluates safety, tolerability, pharmacokinetics, and MTD of single, ascending doses of CJC-1131 in patients with stable Type 2 diabetes and will obtain preliminarily pharmacodynamic and efficacy data for CJC-1131 as compared to placebo in these patients. In addition, preliminary assessments of efficacy parameters will include monitoring of blood levels for glucose, insulin, C-peptide, glucagon, fructosamine and haemoglobinA(1C). About DAC:GLP-1(TM) (CJC-1131) DAC:GLP-1TM was created using ConjuChem's DAC(TM) Technology to "engineer" an analogue of GLP-1 into a drug construct (CJC-1131). CJC-1131 is designed to be administered by subcutaneous injection and then rapidly and selectively bond in-vivo (inside the body) to albumin. The bioconjugate thus formed has the same therapeutic activity, but has a pharmacokinetic profile (duration of activity) in animals closer to that of albumin, a protein that has a half-life in man of about 2 to 3 weeks.