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

a lipid-vesicle and composition technology, applied in the direction of peptide/protein ingredients, organic active ingredients, pharmaceutical non-active ingredients, etc., can solve the problems of examining the hpv status post, unable to immediately treat women with hpv, and undergone such treatment options may carry an increased risk of abortion and premature labor
US20130216610A1Inactive Publication Date: 2013-08-22HELIX BIOPHARMA CORP
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Patent Information

Authority / Receiving Office
US · United States
Patent Type
Applications(United States)
Current Assignee / Owner
HELIX BIOPHARMA CORP
Publication Date
2013-08-22
Estimated Expiration
Not applicable · inactive patent

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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.
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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...

Claims

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