Alnylam Launches Phase I Trial of Inhalable RSV Therapy
Alnylam Pharmaceuticals said this week that it has initiated a US phase I trial of an inhalable formulation of its investigational respiratory syncytial virus drug ALN-RSV01.
Alnylam had previously conducted two phase I trials of an intranasal version of the RNAi drug, establishing its safety and tolerability (see RNAi News, 5/4/2006). The company said that inhalable ALN-RSV01 is designed to deliver the therapy directly to the lungs and is the expected formulation for the treatment of naturally infected RSV patients.
Alnylam expects to initiate an experimental infection study with the intranasal formulation of ALN-RSV01 in healthy adult volunteers later this year.
Benitec Issues Shares to Promega for an 8-Percent Stake
Benitec said this week that it has provided about 16 million of its shares to Promega, representing an 8-percent stake in the company.
According to Benitec, the shares were provided to convert $175,000 in debt. Promega has also been issued a convertible promissory note to buy another $158,333 worth of shares in 12 months.
While Promega was once close with Benitec, acquiring an exclusive license with sublicense rights to the company’s expressed RNAi technology for research applications, the relationship soured when Benitec sued its partner for failure to pay royalties (see RNAi News, 7/30/2004).
The companies eventually settled their dispute, with Promega taking a non-exclusive license to the technology. Since then, Benitec has also undergone an extensive restructuring that included laying off essentially its entire staff and shelving its in-house drug programs (see RNAi News, 6/29/2006).
Genta’s Proposal for Genasense Trial Completes FDA Review
Genta said this week that its proposal for a randomized trial of the antisense cancer drug Genasense in patients with chronic lymphocytic leukemia has completed a special protocol assessment by the US Food and Drug Administration.
According to the company, the SPA, which was filed in December 2005, “documents agreements regarding the trial's design and planned analysis.”
Genta has submitted a new drug application for Genasense as part of a combination therapy for CLL. A decision by regulators is expected around the end of the month.
In September, an FDA advisory panel recommended the agency not approve Genasense for CLL, sending shares of the company tumbling (see RNAi News, 9/7/2006). The FDA is not obligated to follow its advisory panels’ recommendations, but usually does.
Previously, Genasense failed to prove effective in phase III testing in its key indication, melanoma. This setback led to the dissolution of a marketing deal between Genta and Sanofi-Aventis.
"While the NDA remains under active review, we will provide Genasense at no cost to CLL patients in response to single-patient IND requests — also known as compassionate use requests,” Genta CEO Raymond Warrell said in a statement. “We will not make a decision whether to proceed with this new trial until we have had our requested meeting with FDA to review the status of the pending NDA."
Invitrogen Laid Off 60 Staffers in August; Will Lay Off 34 More Oct. 27
Invitrogen laid off 60 employees on Aug. 31 and plans to lay off an additional 34 staffers on Oct. 27, according to California employment records.
The August lay-offs were in Invitrogen’s South San Francisco, Calif., facility, while the ones scheduled for Oct. 27 will be in the company’s Burlingame space, GenomeWeb News, an RNAi News sister publication, reported last week.
It was not immediately clear what businesses or departments have been or will be affected. The lay-offs represent approximately 2 percent of the company's 4,800 employees worldwide.
What is known is that the South San Francisco facility comprises Zymed Laboratories, the antibody manufacturer Invitrogen bought at the start of 2005, while the Burlingame space comprises Caltag Laboratories, a maker of antibodies and reagents for flow cytometry applications that Invitrogen acquired in the summer of that year, GenomeWeb News reported.
It was not immediately clear whether other business units are affected. Also not immediately clear is whether the lay-offs are tied to the formal business reassessment that has been ongoing at Invitrogen since the company disclosed lackluster second-quarter revenue growth and cut its full-year 2006 revenue forecast in August.
An Invitrogen spokesperson declined to comment.