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 SAN DIEGO, Jan. 6 /PRNewswire/ -- Syntello Inc., a biopharmaceutical firm based here, has signed a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), to develop a mucosal vaccine against chlamydia, the leading cause of bacterial sexually transmitted disease in the United States and the industrialized world.
 Under the agreement, Syntello will develop a recombinant chlamydia vaccine combining its novel cholera toxin-B (CTB) mucosal carrier with highly immunogenic, synthetic chlamydia peptides developed by Harlan D. Caldwell, Ph.D., chief of NIAID's Laboratory of Intracellular Parasites in Hamilton, Mont.
 Syntello's CTB mucosal carrier, developed by Jan Holmgren, M.D., Ph.D., of the University of Gothenburg, Sweden, is the basis for a new class of vaccines designed to provide targeted immunity at the site of infection on the mucosa -- the thin protective membrane lining cavities or canals of the body that open to the outside. In addition to its effectiveness as a carrier, the B subunit molecule is biologically active and may function as a natural adjuvant, stimulating strong immune responses.
 Chlamydia attacks cells of the mucosal tissue surface, including the female reproductive tract where the bacteria frequently causes pelvic inflammatory disease (PID). Left untreated, PID can so severely scar the fallopian tubes that infected women can become infertile. In the United States, as many as 1 million women each year are treated for PID, the Centers for Disease Control (CDC) in Atlanta estimates, at a cost of more than $5 billion.
 "This agreement with NIAID represents a major step toward developing what may be a first generation vaccine against chlamydial infection and the first effective vaccine for any bacterial sexually transmitted disease," said Larry Stambaugh, chairman and chief executive officer of Syntello. "We are gratified by the NIAID's choice to collaborate with Syntello, bringing together the scientific, technological, and commercial resources that are needed to make a chlamydia vaccine a reality."
 Steadily increasing in the United States since 1984, genital chlamydia infections affect 4 million people annually and cause infertility in more than 20,000 women, according to the CDC. In 1991, the reported number of chlamydia infections in women exceeded the reported numbers of women with gonorrhea for the first time since the CDC began tracking this disease.
 Chlamydia infections are often asymptomatic (silent) and, if left untreated, can lead to tubal infertility and ectopic pregnancies (outside of the uterus) in women and inflammation of the epididymis, which store sperm, in men. The disease also can be transmitted from an infected mother to her child during birth. Many women will not discover they are infected until they try to get pregnant.
 When the candidate vaccine is proven in animal studies, Syntello plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration to begin human clinical trials.
 "We believe Dr. Caldwell's peptide is the correct choice for a vaccine protein and, once coupled to our CTB carrier, may stimulate targeted immunity that was previously impossible," said Stambaugh. "The CTB carrier is crucial to making the vaccine complete because of its ability to transfer the NIAID peptide into the mucosa and to independently stimulate an immune response."
 Using the new method of vaccine delivery developed by Syntello, we will attempt to induce critical antibodies by targeting the chlamydia vaccine at the surface of the genital tract mucosa," explained Caldwell.
 Caldwell developed the A8-VDIV peptide from the major outer membrane protein (MOMP) of C. trachomatis. Coupled with this peptide, it is believed Syntello's CTB-carrier technology represents the best strategy for eliciting mucosal protective immunity at the site of infection.
 "Our review of Dr. Caldwell's impressive body of work shows that MOMP peptides are the most promising immune stimulators against a broad variety of chlamydia strains," said Holmgren. "We are very hopeful the collaboration will produce a viable solution to this serious disease."
 Developed by Holmgren, Syntello's CTB mucosal vaccine carrier is widely recognized as the most effective and safe mucosal carrier known today. The carrier molecule is now being tested as a key component of a new oral cholera vaccine, produced in Sweden, that has been administered to more than 200,000 patients worldwide. Results have shown that CTB is highly effective at delivering a vaccine and stimulating an immune response at the appropriate site of absorption for mucosal immunity, a response not previously possible. Acting as an immune enhancer, or adjuvant, CTB can also induce a higher level of antibody production by the body.
 Established by Congress, the Federal Technology Transfer Act of 1986 created CRADAs as technology-transfer vehicles designed to transform research developed by or on behalf of the U.S. government into functional solutions to public health problems.
 In addition to its laboratories in Bethesda, Md., and Hamilton, NIAID supports research and training of non-federal scientists at universities, medical schools, hospitals, and research institutions throughout the United States and abroad. These investigations are aimed at preventing, diagnosing, and treating such illnesses as AIDS, tuberculosis, allergies, and asthma. NIH is an agency of the U.S. Public Health Service in the U.S. Department of Health and Human Services.
 Syntello is a biopharmaceutical firm focused on the research and development of immunotherapeutics for the prevention and treatment of infectious diseases. The San Diego-based company is applying its proprietary enabling technology to a new class of vaccines designed to provide "targeted immunity" to disease-susceptible tissues. Its first product will be the adult vaccine developed through the CRADA for immunizing the mucosal lining of the genital tract against chlamydia.
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 /CONTACT: Larry G. Stambaugh, chairman, CEO, Syntello Inc., 619-592-7999; or Tom Gable or Kris Lichter, Gable/Versaggi Biocommunications, 619-234-1300/

CO: Syntello Inc.; National Institute of Allergy and Infectious
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JM-LS -- SD003 -- 9641 01/06/94 08:34 EST
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Date:Jan 6, 1994

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