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Genta, Isis Pharmaceuticals, Alnylam Pharmaceuticals, Asuragen, Oxford BioMedica, Sigma-Aldrich, GSK

Genta Cuts Staff by 35 Percent After FDA Rejection of Lead Drug
Antisense drug developer Genta said this week that it has restructured itself following the rejection of its lead cancer drug candidate, Genasense, by the US Food and Drug Administration for chronic lymphocytic leukemia.
As part of the restructuring, the company said it has reduced its staff by 34 people, or about 35 percent. It also said the restructuring will allow it to focus on its oncology development pipeline.
"At the end of the third quarter, Genta had cash and cash equivalents totaling approximately $40 million dollars, and today's actions will result in severance costs of approximately $700,000,” Genta Chairman and CEO Raymond Warrell said in a statement.

iCo Files IND for Isis-Developed AMD, Diabetic Retinopathy Drug
Isis Pharmaceuticals said this week that iCo Therapeutics has filed an investigational new drug application with US regulators to begin human testing of iCo-007, an antisense-based treatment for age-related macular degeneration and diabetic retinopathy.
Isis discovered and designed the drug, which inhibits production of c-Raf kinase, and licensed it to iCo. Isis said it will receive an undisclosed milestone payment based on the IND submission.

Alnylam Closes $101M Public Stock Offering
Alnylam Pharmaceuticals last week announced the closing of its public offering of 4.7 million shares of its common stock.
As expected, the net proceeds of the offering were about $101 million.

Asuragen Receives ISO 13485, 9001 Certification
Asuragen said last week that it has received ISO 13485 and 9001 certification for the quality-management system for its medical devices.
"The ISO 9001/13485 certification is another important milestone for Asuragen in becoming a premier molecular diagnostics company," Matt Winkler, CEO and CSO of Asuragen, said in a statement. "With our cGMP capabilities and ISO certifications, we are well positioned to implement our strategy for international expansion."
Asuragen was formed earlier this year by Winkler, who founded and sold Ambion to Applied Biosystems (see RNAi News, 1/12/2006). The new company is developing products to assist in early cancer diagnosis and predict treatment outcomes, including ones that use microRNAs.

EPO Reinstates Isis Antisense Patent with Amended Claims
Isis Pharmaceuticals said this week that the European Patent Office has reinstated, with amended claims, a company-owned patent covering antisense drugs with chimeric or gapmer structures.
The patent, EP0618925, specifically covers “a class of antisense compounds, any of which is designed to have a sequence of phosphorothioate-linked nucleotides having two regions of chemically modified RNA flanking a region of DNA,” Isis said.
Originally granted in 2001, the patent was opposed by several parties and revoked by the EPO about two and a half years later.
“Virtually all antisense drugs currently in development, or likely to be developed in the near future, have gapmer compositions pioneered by Isis and covered by this issued patent,” Isis Chairman and CEO Stanley Crooke said in a statement. “We are pleased that the EPO recognizes Isis' inventions and we intend to fully exercise our rights under this patent.”

Oxford BioMedica, Sigma-Aldrich License LentiVector Tech to GSK
Oxford BioMedica and Sigma-Aldrich said this week that they have signed a joint license agreement giving access to their LentiVector gene-delivery technology to GlaxoSmithKline for research purposes.
Financial terms of the deal were not disclosed.
LentiVector was developed by Oxford BioMedica, which signed on Sigma-Aldrich as its strategic partner and exclusive licensee for commercialization of the technology in the research field, according to the companies.

The Scan

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.