PipelineReview.com - Biotech News & Online Store - ConjuChem Successfully Completes Patient Enrollment of its Phase II Trial of DAC(TM):GRF for Treatment of HIV Lipodystrophy

ConjuChem Successfully Completes Patient Enrollment of its Phase II Trial of DAC(TM):GRF for Treatment of HIV Lipodystrophy

21 Jun 2006

MONTREAL, Canada | Jun 20, 2006 | ConjuChem Biotechnologies Inc. (TSX: CJB - News) today announced it has completed the

enrollment of its phase II trial with DAC(TM):GRF in patients having lipodystrophy associated with HIV. DAC(TM):GRF, a growth hormone therapeutic, is a compound employing the Growth hormone Releasing Factor (GRF) peptide and is being evaluated in a once-weekly dosing regimen.

Study design: The study is a multicenter, randomized, double-blind, placebo-controlled trial in HIV-associated Lipodystrophy patients. The primary endpoint is the change in IGF-1 levels from baseline to week 12. Secondary endpoints include changes in Visceral Adipose Tissue (VAT) and Subcutaneous Adopise Tissue (SAT) (as measured by CT scan), lean body mass, body composition (as measured by DEXA scan), weight and body image assessment.

The protocol randomized 192 patients. Patients were randomized to a low-dose cohort (3-week escalating titration at 60, 90, 120 mcg/kg), a high-dose cohort (3-week escalating titration at 60, 120, 240 mcg/kg) or a placebo cohort. Each cohort is dosed once a week. The study duration is 12-weeks of treatment followed by a 6-week follow-up and a 3-month open label study extension planned at the end of this study.

"We are pleased to complete the recruitment for this Phase II trial and to be in a position to deliver the results as forecasted," said Dr Jean-Paul Castaigne, COO of ConjuChem.

In addition to lipodystrophy associated with HIV, ConjuChem intends to develop DAC:GRF in other indications for adult patients and in Growth Hormone (GH) deficiency in children.

About GRF and DAC(TM):GRF

Growth hormone (GH) is essential to linear growth in children and to the metabolic regulation of carbohydrates, lipids, proteins and minerals. GH is secreted in response to growth hormone releasing hormone (GHRH), also known as growth hormone releasing factor (GRF). GRF has been shown to produce a pulsatile release of GH in humans that is more natural than the bolus daily administration of GH.

Administration of recombinant GH is a well established pediatric treatment for short stature. Current GH has two major drawbacks: it needs be administered daily and is delivered in an unphysiologic, non-pulsatile manner. One of the goals in GH therapy drug development has been to identify a compound that not only delivers sustained increases in growth hormone but does so in a way that mimics the body's natural pulsatile GH secretory pattern.

Although it produces the more natural pulsatile release of GH, GRF's short-half life necessitates multiple daily injections rendering it impractical for clinical use and commercialization. DAC(TM):GRF is a chemically modified form of GRF that covalently binds to albumin, the dominant protein in blood, thus dramatically prolonging the half-life of GRF from minutes to days.

About Lipodystrophy associated with HIV

Lipodystrophy is a condition dominated by fat redistribution, i.e., visceral fat accumulation and subcutaneous fat loss, associated with atherogenic lipid profile (decreased HDL, increased triglyceride and increased cholesterol) and impaired glucose tolerance. No drugs are currently approved for the treatment of HIV Lipodystrophy. In the United States, it is estimated that of the 500,000 HIV patients treated with HAART, 200,000 of them have lipodistrophy.

About ConjuChem

ConjuChem, developers of next generation medicines from therapeutic peptides, is creating long-acting compounds based on Bioconjugation platform technologies. When applied to peptides, the Company's systemic DAC(TM) and PC- DAC(TM) Technologies enable the creation of new drugs with significantly enhanced therapeutic properties as compared to the original peptide. The Company is developing compounds to treat various disorders including diabetes, human growth deficiencies, HIV/AIDS, and congestive heart failure.

Detailed descriptions of the Company can be viewed on the Company's website www.conjuchem.com.

Forward-Looking Statements

Some of the statements made herein may constitute forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause ConjuChem's actual results, performance or achievements to be materially different from those expressed or implied by any of the Company's statements. Actual events or results may differ materially. We disclaim any intention, and assume no obligation, to update these forward-looking statements.

For further information

Lennie Ryer, CA, Vice President Finance, CFO, ConjuChem Inc., (514) 844-5558 ext 224, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Michael Polonsky, Investor Relations, (416) 815-0700 ext. 231, (416) 815-0080, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SOURCE: ConjuChem Inc

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