Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - November 14, 1995
ISIS 5320 acts by a novel mechanism to prevent viral replication by binding to the viral envelope and preventing cell-to-cell and virus-to- cell transmission of the virus. When tested in vitro, in the standard assays used by the National Cancer Institute to test anti-HIV compounds, ISIS 5320 was shown to be active against a broad variety of HIV-1 and HIV-2 strains, including both laboratory-derived and clinical isolates as well as drug resistant strains. The compound was also shown not to result in viral resistance after multiple passages of HIV in the presence of ISIS 5320, and to be additive to, or possibly synergistic with, AZT.
ISIS 5320 inhibits HIV viral replication in the SCID-hu mouse model of HIV infection*. In this model, daily subcutaneous injections of ISIS 5320 were shown to inhibit HIV-1 replication. When compared to untreated mice, a statistically significant reduction in viral p24 protein was obtained in experiments using both a molecular clone and a clinical isolate of HIV-1.
"This notice of allowance represents an important addition to Isis' very broad portfolio of product and technology patents and is a timely complement to the product patents issued to Isis earlier this year on ISIS 2922 and ISIS 2105, our two lead compounds in advanced clinical trials," said B. Lynne Parshall, Senior Vice President and Chief Financial Officer. "Isis is considering developing ISIS 5320 with a partner and this notice of allowance adds significantly to the value of the compound. In light of the preclinical data concerning its antiviral activity, we are hopeful that ISIS 5320 will have a significant therapeutic effect against HIV."
ISIS 5320 is currently in preclinical development supported in part with funding from the National Cancer Institute. An IND for this compound is targeted for the second half of 1996. ISIS 5320 is the first development candidate to emerge from the Isis combinatorial chemistry program, Osiris, which uses novel proprietary chemistries to generate libraries of unique small molecule compounds and to identify therapeutically useful compounds within such libraries as potential drug candidates. ISIS 5320 is not designed to be an antisense drug.
Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has three compounds in human clinical trials: ISIS 2922, to treat CMV-induced retinitis in AIDS patients, is in Phase III clinical trials; ISIS 2105, to treat genital warts caused by human papillomavirus, is currently in Phase II clinical trials as an adjunct to surgery; and ISIS 2302, an inhibitor of ICAM-1, is in Phase II trials for renal transplant rejection, rheumatoid arthritis, psoriasis, Crohn's disease and ulcerative colitis. The company also has several additional compounds in preclinical development. Isis' broad medicinal chemistry and biology research programs support efforts in both antisense and combinatorial drug discovery.
* SCID-hu mice are immunodeficient mice that are transplanted with human fetal liver and thymus tissue. HIV-1 is injected into the human graft and effects of antiviral compounds on viral p24 are determined. The SCID-hu mouse model was developed by SyStemix, Inc. and used by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate compounds exhibiting promising in vitro results against HIV-1.
CONTACT: Jane Green, Director, Investor Relations of Isis, 619-603-3880/ 06:00 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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