Wednesday, November 22, 2006

Drug Pipeline Series: Phase I, Nov 13 - Nov 20, 2006

SURFACE LOGIX PRESENTS POSITIVE DATA ON DYSLIPIDEMIA DRUG
Surface Logix announced the presentation of positive data from its first Phase I clinical trial assessing the safety and tolerability and establishing the pharmacokinetic and pharmacodynamic profile of its investigational drug candidate for dyslipidemia, SLx-4090. Results were presented at the American Heart Association's conference in Chicago.
SLx-4090 is a novel microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia. Surface Logix designed SLx-4090 using its proprietary small-molecule Pharmacomer Technology to act specifically in the gastrointestinal (GI) tract to prevent the transport of fats through the intestinal wall. This unique feature of intestinal selectivity allows activity against fat uptake while avoiding toxicity at other sites of MTP expression including the liver, heart, testis, ovary and eye, according to the company.


SOSEI BEGINS TRIAL OF EMERGENCY CONTRACEPTIVE PILL
Sosei has announced the initiation of a Phase I clinical trial for the emergency contraceptive pill NorLevo. Sosei acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma, and it is currently approved and marketed in more than 50 countries.
NorLevo is an oral emergency contraceptive used to prevent pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse.
As a result of a large multinational study in 1998, the World Health Organization (WHO) demonstrated that levonorgestrel monotherapy, such as NorLevo, was well-tolerated and more effective than the Yuzpe method (ethinyl estradiol and levonorgestrel), an emergency contraception method used since 1977. Levonorgestrel monotherapy for emergency contraception is listed by WHO as an essential drug, according to Sosei.

Seattle Genetics Initiates Phase I Clinical Trial of SGN-35
Seattle Genetics, Inc. announced that it has initiated a phase I clinical trial of SGN-35 for patients with Hodgkin's disease and other CD30-positive hematologic malignancies. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The single-agent, dose-escalation phase I study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's disease. The trial is expected to enroll up to approximately 40 patients at multiple centers in the United States.

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