Alnylam Begins European Phase I Trial of RSV Drug
Alnylam Pharmaceuticals said this week that it has begun its European phase I trial of the respiratory syncytial virus treatment ALN-RSV01, and that a US phase I study of the drug is set to begin before the new year.
ALN-RSV01 is an intranasally delivered RNAi drug that targets the RSV nucleocapsid "N" gene, which is essential for viral replication. The drug became Alnylam's lead product candidate after the company dropped plans to develop an RNAi-based treatment for age-related macular degeneration (see RNAi News, 9/23/2005).
According to Alnylam, the European trial is expected to enroll 57 healthy adult males. "Drug or placebo will be administered intranasally in both single ascending doses across three cohorts and in multiple ascending doses daily for five consecutive days across three cohorts," the company said.
Alnylam also said that its investigational new drug application to begin clinical testing of ALN-RSV01 has passed the US Food and Drug Administration's 30-day review period, keeping the company on track to begin a US phase I trial before the end of the month.
This study is expected to enroll 35 healthy males. Drug or placebo will be administered intranasally in single ascending doses across five cohorts, the company noted.
In both studies, ALN-RSV01 will be evaluated for safety, tolerability, and pharmacokinetics, and Alnylam said it expects to have preliminary data available from these trials in the first half of 2006.
Genome-Wide RNAi Global Initiative Holds First Meeting
The first meeting of the Genome-Wide RNAi Global Initiative, an alliance of reagent provider Dharmacon and international non-profit biomedical research centers, has concluded, the company said this week.
As reported by RNAi News, Dharmacon established the initiative in order to facilitate the use of its siArray human genome siRNA library by research institutions in order to accelerate drug discovery and development (see RNAi News, 10/7/2005).
According to Dharmacon, the first meeting "focused on developing standardized procedures for data gathering intended to accelerate the group's progress. Participants shared best practices and successes from preliminary human genome-wide siRNA screening and discussed how they might collaborate to accelerate biomedical discovery using the genome-wide library," the company said.
Dharmacon also said that the attendees agreed to "identify standards that will facilitate generation of reproducible intra-laboratory results," an effort termed MIARE, for Minimal Information About RNAi Experiments. They also agreed to seek input from external sources.
The initiative members plan to meet twice a year, Dharmacon noted.
CytRx Given Extension to Meet Nasdaq Trading Requirement
CytRx said this week that it has been given an extension until June 2, 2006, to regain compliance with the Nasdaq's $1 minimum bid price requirement.
The company previously had until Dec. 5 to bring its stock price back up to a minimum of $1 for at least 10 consecutive trading days (see RNAi News, 10/7/2005).
The Nasdaq requires that shares of companies listed on the exchange trade at $1 or greater for at least 10 consecutive business days. If a company fails to meet this requirement, its stock faces delisting.