Maxim Pharmaceuticals Announces Publication of Human Mucosal Vaccine Study.SAN DIEGO--(BW HealthWire)--July 16, 1998-- Demonstrates Potential of MaxVax(TM) Carrier/Adjuvant to Stimulate Human Mucosal Immune Responses Using Nasal and Oral Applications Maxim Pharmaceuticals (AMEX AMEX See: American Stock Exchange :MMP MMP Matrix Metalloproteinase (enzymes related to tissue healing/remodeling and cancer cell metastasis) MMP Mixed Member Proportional (New Zealand electoral system) MMP Multi-man Publishing , SSE (1) An earlier full-screen editor in OS/2. (2) (Streaming SIMD Extensions) A series of additional instructions built into Pentium CPU chips for improved multimedia performance by performing mathematical operations on multiple sets of data at the :MAXM) today announced publication in "Infection and Immunity Infection and Immunity is an academic journal published by the American Society for Microbiology. The title is commonly abbreviated IAI and the ISSN is 0019-9567 for the print version, and 1098-5522 for the electronic version. " of a human vaccination study that demonstrated mucosal antibody responses in female volunteers after nasal and oral application of recombinant cholera toxin cholera toxin Infectious disease A heat-sensitive multimeric enterotoxin produced by Vibrio cholera, which transfers ADP-ribose to a G protein, locking adenyl cyclase in an 'on' position by ADP ribosylation of a Gs protein B subunit (rCTB). The study also showed that nasal administration of rCTB demonstrated prolonged mucosal and serum antibody responses in female volunteers when compared to a similar vaccine given orally. rCTB is the delivery molecule for the company's proprietary MaxVax mucosal vaccine carrier/adjuvant system. The study, supported by Maxim, is described in a paper by Rudin, et al. titled "Differential Kinetics and Distribution of Antibodies in Serum and Nasal and Vaginal Secretions after Nasal and Oral Vaccination of Humans." The female volunteers were immunized nasally or orally with rCTB, and the researchers subsequently measured the antibody levels in serum, nasal secretions and vaginal secretions, as well as the number of circulating antibody-secreting cells. The researchers concluded that the nasal route is superior to the oral route for administering certain vaccines against infections in the upper respiratory tract respiratory tract n. The air passages from the nose to the pulmonary alveoli, including the pharynx, larynx, trachea, and bronchi. Respiratory tract , whereas either oral or nasal administration might be used for eliciting antibody response in the female genital tract genital tract n. The genital passages of the urogenital system. Genital tract The organs involved in reproduction. . "The results are important as they confirm in humans the results of earlier animal studies in which rCTB has been shown to stimulate strong mucosal immune responses," said Dr. Kurt Gehlsen, vice president, development and chief technical officer at Maxim. "For ease of administration and patient compliance, oral and nasal administration reflect the two most attractive routes for the delivery of mucosal vaccines." Most of today's vaccines are administered by injection and stimulate a protective immune response in the systemic immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . However, it is the mucosal membranes lining the eyes, nose, mouth, ears, lungs, intestinal and urogenital urogenital /uro·gen·i·tal/ (-jen´i-tal) genitourinary. u·ro·gen·i·tal or u·ri·no·gen·i·tal adj. Genitourinary. tracts where nearly 85 percent of the infectious diseases enter the body. It is widely believed that the stimulation of a greater number of immunocytes at the primary site of infection would provide important benefits for protecting against the majority of human pathogens. The company's MaxVax technology, currently in preclinical development, utilizes the strong immune response amplification characteristic of rCTB as a carrier/adjuvant for immunogens selected as vaccine candidates. rCTB has previously been shown to be well tolerated in when administered to the mucosa, where majority of bacterial and viral pathogens enter the body. Potential indications for MaxVax include a new class of vaccines for sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely , major respiratory infections and gastrointestinal tract diseases. Maxim Pharmaceuticals is developing therapeutics and vaccines for the prevention and treatment of cancer and infectious diseases. Maxim's focus is to develop novel products that include pharmacoeconomic and disease management benefits such as out-patient therapy, improved clinical efficacy, higher level of safety, cost effective treatment and improved patient compliance. The company has initiated three Phase III cancer clinical trials for its lead product Maxamine(TM) in the U.S., Europe and Australia for malignant melanoma and acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. . Other Phase II and III trials of Maxamine Therapy(TM) are ongoing or planned for other cancer indications including renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. , multiple myeloma and prostate adenocarcinoma adenocarcinoma: see neoplasm. . Maxamine Therapy has also been tested in Europe in a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for the treatment of hepatitis C patients. The company's secondary platform technology, MaxVax, now in preclinical development, utilizes a mucosal vaccine carrier/adjuvant system for a broad range of infectious diseases. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies. This news release contains forward-looking statements that involve risks and uncertainties. The company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include, but are not limited to, those discussed under "Risk Factors" and elsewhere in the company's Annual Report on Form 10-K for the year ended September 30, 1997 and the company's Registration Statement on Form S-3 (File No. 333-52403-LA), as amended through the date hereof, each as filed with the Securities and Exchange Commission, including the uncertainties associated with product development, the risk that the company will not obtain marketing approval for its products, and the risks associated with dependence on collaborative partners. Note: Maxamine, Maxamine Therapy, MaxVax and the Maxim logo are trademarks of the company. Editor's Note: This release is also available on the Internet at: http://www.noonanrusso.com.
CONTACT: Maxim Pharmaceuticals
Larry G. Stambaugh, Dale A. Sander, 619/453-4040
or
Noonan/Russo Communications
Neil Cohen, 212/696-4455 ext. 205
John-Kenneth Billingsley, 212/696-4455 ext. 232
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