Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery

Abstract

A biphasic lipid vesicle composition for treating cervical displasia by intravaginal delivery. The composition includes a suspension of lipid-bilayer vesicles having entrapped therein, an oil-in-water emulsion, human interferon alpha-2b and L-methionine, the composition having an interferon alpha-2b specific activity of between about 1-10 MIU (million international units) per gram composition, and between 0.01 to 0.5 weight percent L-methionine. In the treatment method, the composition is administered at a dose of between about 1-20 MIU interferon alpha-2b, and this dose is administered at least 3 days / week, for a period of at least 4 weeks.

Description

FIELD OF THE INVENTION[0001]The present invention relates a biphasic lipid-vesicle composition and method for treating cervical displasia by intravaginal delivery.BACKGROUND OF THE INVENTION[0002]Of the estimated 55 million Pap smears performed each year in the United States, more than 5% are reported as abnormal (ALTS study 2003). An estimated 800,000 women each year present with low-grade squamous intraepithelial lesions (LSIL) (Jones, B A, Davey D D. Quality management in gynaecologic cytology using interlaboratory comparison. Arch Pathol Lab Med 2000; 124(5):672-81).[0003]These lesions will either progress with time to CIN 2-3 or invasive cancer, especially in women that present with the high-risk HPV-subtype, or regress with time in the absence of treatment. Of women diagnosed with LSIL, 25% will progress to cervical intraepithelial neoplasia (CIN) grade 2 or 3, 22-32% will have persistent CIN 1 and approximately 50%-70% will experience spontaneous regression of LSIL within 2 y...

AI Technical Summary

Benefits of technology

This invention is about a cream-like substance that can be used to treat cervical dysplasia. The substance contains tiny bubbles made of fat that have been mixed with a solution containing human interferon alpha-2b and methionine. The substance has a high level of interferon alpha-2b, which is an important protein, and a small amount of methionine, which is an amino acid. The substance is applied through a vaginal applicator and should be used for at least 4 weeks. The treatment can help to improve the abnormal growth of cells in the cervix and reduce the likelihood of cervical cancer.

Problems solved by technology

At present, there is no immediate therapy available for women with HPV presenting with LSIL.

Women who have undergone such treatment options may carry an increased risk of abortion and premature labor.

While these studies show that interferon therapy is effective in treating CIN associated HPV infections as measured by colposcopy confirmed by cytological and histological examination of random biopsies, none of these studies examine the HPV status post therapy.

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