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Genta, Sirna Therapeutics, AVI BioPharma, Invitrogen and NIH Institutes, Qiagen, and Isis Pharmaceuticals and Eli Lilly


FDA Advisory Panel Recommends Against Approval of Genta Antisense Drug

Genta said this week that the US Food and Drug Administration’s Oncologic Drugs Advisory Committee has voted that the company’s phase III trial for its antisense cancer drug Genasense does not indicate the drug’s efficacy is substantial enough to outweigh its risks.

The FDA is not bound to follow the advice of its advisory committees, although it usually does. The news devastated Genta’s stock, which tumbled more than 40 percent.

“We strongly believe in the potential of Genasense and what it represents to patients with advanced melanoma,” Raymond Warrell, Genta’s chairman and CEO, said in a statement. “We are committed to its ongoing development and we will work closely with the FDA to determine the appropriate next steps.”

Frank Douglas, Aventis board member and executive vice president of drug innovation and approval, added that “while disappointing, the committee’s vote underscores the complexities of treating this devastating disease.

“We will work with our partners at Genta to address any outstanding questions from the FDA,” Douglas added.

Sirna to Place At Least $18 Million in Common Stock

Sirna Therapeutics said this week that it has closed the private placement of $18.7 million worth of its common stock with independent institutional investors.

JP Morgan Securities Inc. acted as the lead-placement agent, with Thomas Weisel Partners serving as the co-placement agent.

“The completion of the current financing has allowed us to broaden our investor base with well-respected institutional investors, as well as further strengthen our cash position,” Howard Robin, president and CEO of Sirna, said in a statement.

Sirna had about $29.6 million in cash, cash equivalents, and securities-available-for-sale as of March 31.

AVI Reports First-Quarter Financials

AVI BioPharma reported this week revenues of $99,451 for the first quarter 2004, down from $257,923 in the year-ago quarter. The company attributed the decline to lower research contracts revenues.

Research and development spending rose in the first quarter, to $6.6 million from $2.8 million. AVI reported a net loss in the first quarter of $7.5 million, up from $3.4 million in the first quarter of 2003.

As of March 31, AVI had cash, cash equivalents, and short-term securities worth $36.4 million.

Invitrogen Licenses Gateway, Other Technologies to NIH Institutes

Invitrogen said this week that it has signed an agreement with the National Human Genome Research Institute and the National Cancer Institute to provide the institutes with open access to its Gateway and SuperScript technologies for use with genes captured in the Mammalian Gene Collection Program.

Gateway is a method for cloning DNA sequences for functional study. According to Invitrogen, its Gateway technology open architecture licensing policy allows academic and government researchers that purchase the system to be able to create and distribute clones within the scientific community.

The Mammalian Gene Collection program is an NIH-funded effort to generate sequenced full-length cDNAs.

Qiagen Reports on First-Quarter Financial Results

Qiagen reported this week increased revenues and slightly higher earnings for the first quarter of 2004.

The company booked $96.1 million in revenues, up from $79.6 million during the same quarter last year. Almost 80 percent of revenues resulted from consumables, and about 10 percent each from instruments and oligos.

Research and development costs climbed to $9.4 million, from $7.5 million during the same quarter in 2003.

Qiagen’s net income increased slightly to $11.4 million, or $.08 per share, from $11 million, or $.08 per share, during the year-ago period.

As of March 31, Qiagen had $108.8 million in cash and cash equivalents.

Isis, Lilly Expand Cancer Partnership

Isis Pharmaceuticals said this week that it has expanded its antisense cancer drug development collaboration with Eli Lilly to include work on RNase H, siRNAs, and splicing modulating inhibitors for the treatment of cancer.

The companies first began their partnership in June 2002, said Isis.

The deal comes on the heels of the signing of a strategic partnership between Isis and Alnylam Pharmaceuticals (see RNAi News, 3/19/2004).

The Scan

Tens of Millions Saved

The Associated Press writes that vaccines against COVID-19 saved an estimated 20 million lives in their first year.

Supersized Bacterium

NPR reports that researchers have found and characterized a bacterium that is visible to the naked eye.

Also Subvariants

Moderna says its bivalent SARS-CoV-2 vaccine leads to a strong immune response against Omicron subvariants, the Wall Street Journal reports.

Science Papers Present Gene-Edited Mouse Models of Liver Cancer, Hürthle Cell Carcinoma Analysis

In Science this week: a collection of mouse models of primary liver cancer, and more.