KOLOBOV A, SIMBIRTSEV A, BOKOVANOV V, VASIL'EVA G, TUTHILL C, RUDOLPH A; Interscience Conference on Antimicrobial Agents and Chemotherapy (42nd : 2002 : San Diego, Calif.).
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2002 Sep 27-30; 42: abstract no. L-676.
Verta Ltd., St.Petersburg, Russian Federation.
BACKGROUND: The novel synthetic dipeptide g -D-glutamyl-L-tryptophan (SCV-07) has been shown to stimulate T-lymphocyte differentiation and specific immune responses, and enhance IL-2 and INF-g production. Due to this preferential activation of Th1 cytokine production, SCV-07 may show utility in treatment of tuberculosis. In a murine model of tuberculosis induced with M. bovis, SCV-07 was shown to decrease lethality and incidence of lesions in lung and spleen. The purpose of this study was to evaluate treatment of human pulmonary tuberculosis with SCV-07. METHODS: Two single-arm, phase 2 trials were conducted. 35 patients were treated with 100 microg SCV-07, and 9 patients with 10 microg SCV-07, by i.m. injection daily for 5 days, in addition to standard anti-tuberculosis chemotherapy. 27 control subjects (matched for age, previous therapy, and type of tuberculosis) did not receive SCV-07 in addition to standard therapy. RESULTS: SCV-07 treatment markedly improved clearance of mycobacteria; negative sputum cultures were observed in 57% of SCV-07 treated patients compared to 19% of the controls after a month of observation, and in 80% treated versus 37% controls after 3 months. A positive effect of SCV-07 on cavity healing was also seen, as well as improvements in immune parameters. Finally, the patients' symptomatic state (fever, weakness, sweating, dry cough, productive cough, dyspnea, chest pain, tachycardia) was improved in all cases. No systemic or local adverse effects due to SCV-07 treatment were observed. CONCLUSIONS: The results suggest that immunotherapy with SCV-07 provides a beneficial effect in combination with antituberculosis therapy.
Publication Types:
Keywords:
- Antitubercular Agents
- Case-Control Studies
- Clinical Trials as Topic
- Dipeptides
- Humans
- Immunotherapy
- Interleukin-2
- Mycobacterium
- Mycobacterium Infections, Atypical
- SCV-07
- Tuberculosis
- Tuberculosis Vaccines
- Tuberculosis, Pulmonary
- gamma-glutamyltryptophan
Other ID:
UI: 102267513
From Meeting Abstracts