The U.S. Department of Agriculture has approved Syntro Corp.'s viralvector vaccine against Newcastle disease and fowlpox in poultry.Syntro President and CEO J. Donald Todd said the geneticallyengineered vaccine, called VectorVax FP-N, was developed byinserting immunity-inducing genes from the Newcastle disease virusinto a fowlpox transport vector virus to make a vaccine that protectspoultry against both diseases.The USDA approval, Todd told BioWorld, is the first for a Category IIIbiotechnology-derived veterinary product, which is characterized byforeign gene insertion to create live recombinant vaccines. Category IIincludes live recombinant vaccines modified by gene deletion.Category I vaccines are inactivated, non-multiplying microbes that aregenetically altered.Syntro's stock (NASDAQ: SYNT) closed Monday at $2.38 a share, up38 cents.Todd said Syntro, of Lenexa, Kan., also is developing viral vectorvaccines for swine, cattle, horses and cats. The technology, he added,would be the same for making human vaccines, which are part ofSyntro's long-term plans. Todd said the company is conducting earlystage research for human products and is involved in "activediscussions" to establish alliances with pharmaceutical andbiotechnology companies.Viral vectors, Todd said, have potential human applications in genetherapy, cancer treatment and production of diagnostic and therapeuticproteins as well as immune response modulation.Syntro and its subsidiary, SyntroVet Inc., developed the VectorVax FP-N in association with Nippon Zeon Co. Ltd., of Tokyo. Under theagreement, Syntro has manufacturing rights in the U.S. and will receiveroyalties on sales. Decisions on manufacturing for sales outside theU.S. have not been completed.A collaborative group, called Syntro Zeon L.C., has marketing rightsfor the vaccine worldwide except Japan. It will launch sales within thenext several weeks in the U.S.Todd said viral vector vaccines have three main advantages overconventional vaccines. They activate a cell-mediated immune response,reduce risk of post-vaccination reactions and have the capability toprotect against more than one disease.Newcastle disease is an influenza-type virus that can kill poultry.Fowlpox is a viral infection that strikes mostly egg-laying birds in theU.S. and reduces output. Syntro said the potential annual market in theU.S. for VectorVax Fp-N is $9 million to $12 million; worldwide, themarket is estimated at $45 million to $60 million a year. n080294
-- Charles Craig
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