Bio-Rad has developed two new fully automated testing systems for the detection of BSE ("Mad Cow" disease). In conjunction with these systems, the company is introducing a second-generation BSE screening test, along with the first commercially available Western blot confirmation test sensitive enough to be used to verify the screening results. The new confirmatory test can produce results in one day, compared with the up to three days required for the traditional immunohistochemistry confirmatory test. The combination of the new systems and these tests should result in considerable saving of time and labor in laboratories performing the required BSE tests. They will be launched over the next two months, subject to approval by the regulatory authorities.

Nabi Corp. announced February 13, 2002, that a single injection of its experimental vaccine StaphVAX™ - an Staphylococcus aureus polysaccharide conjugate vaccine - reduced blood stream S. aureus infections in end-stage kidney disease patients by almost 60%. These results are from a Phase II clinical trial reported in the February 14 issue of The New England Journal of Medicine. The trial was conducted by investigators from Kaiser Permanente in collaboration with scientists from the NIH and Nabi.

Infigen and its agricultural affiliate, Genmark, announced on February 11, 2002, the successful production of the agricultural industry's first clones of adult pigs. The clones were from two boars renowned for superb offspring and were produced from nonfetal cells. Three nuclear transfers from the cell line created from the boar "The Man" resulted in one successful pregnancy with the litter arriving on January 14. Three nuclear transfer from cells from the other champion boar "401K" (now deceased) yielded three successful pregnancies, farrowed on December 25, January 6, and January 14. All piglets are doing well.

Prairie State Semen (PSS), owners of the two boars, stated that "the clones would greatly expand the industry's access to the highly meritorious genetics of these two boars, to benefit the swine breeding and show pig communities worldwide." "The Man" is a Champion Yorkshire pig and cost PSS $77,000 at the 2000 Indiana State Fair, a breed record at that time, while "401K" was bought for $43,000 in 1997, another record. Dr. Michael Bishop, President and Chief Scientific Officer of Infigen said that "these clones demonstrate that our nuclear cloning technology is a highly efficient, economical approach and a proven platform for propagating animals of high genetic merit.

GlaxoSmithKline stated on January 31, 2002, that it will begin a Phase I clinical trial this year in the US of a vaccine intended to prevent HIV infections. The vaccine was developed at the GSK Vaccine Unit in Rixensaart, Belgium. It contains two key HIV surface proteins plus an adjuvant. Studies in rhesus monkeys demonstrated the vaccine's ability to protect them against simian immunodeficiency virus, a potent surrogate for HIV.

This announcement came a few days after a statement published by Dr. John Moore of Cornell University, who stated in Nature that rivalry between the National Institutes of Health and the Department of Defense in HIV vaccine development is hindering the process in the US. He claims there is competition for funding and a duplication of effort. He wrote that "This state of affairs should not be allowed to continue. A coordinated effort could make so much more progress than one that is fractured by institutional rivalries." Moore described separate efficacy trials planned by both NIH and the DoD of a similar type of HIV vaccine that few independent scientists think will work, considering that "it is arguable whether it needs to be done once, but it certainly doesn't need to be done twice."

Then, on February 5, GenVec announced that it received a contract from the Vaccine Research Center at NIAID to use its adenovirus vector technology to develop and manufacture clinical grade vaccine candidates for the prevention of AIDS. Preclinical studies have suggested that using replication-deficient adenovirus vectors, such as those developed by GenVec, to express virus-associated proteins can elicit potent and protective B cell and T cell immune responses. The contract has been issued and will be managed on behalf of NIAID by SAIC Frederick, Inc. In addition to this contract, GenVec has had a CRADA with NIAID since October 2001 to evaluate and develop adenoviral vectors expressing modified HIV-1 genes.

Lastly, a potentially very useful advance in the administration of lyophilized products was recently described by PenJet® Corp. The company has received a US patent for mixing a lyophilized drug with a diluent in a needleless injector prior to administration. The PenJet device is about half the size of a fountain pen and administers the product through the skin by a patented self-contained inert gas system. It can be packaged with a lyophilized drug in its integral ampoule. The user docks the diluent container in front of the ampoule and the diluent is transferred into the drug container. There is a "shuttle" system that allows the dissolved drug to be passed back and forth between the two chambers for thorough mixing. The diluent container is then removed and the reconstituted drug is injected. The PenJet is single-use and disposable. It can be safely disposed, as it has no needle and all the drug is dispensed.

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