Claims for Patent: 6,896,888

Summary for Patent: 6,896,888

Title:	Treatment of papilloma virus infection using a mycobacterium
Abstract:	Disease cased by papilloma virus is treated by applying an effective amount of Mycobacterium to the region of infection. Specifically, condylomata acuminata are caused by human papilloma virus infection. Despite numerous treatment modalities these patients often demonstrate recurrent disease. BCG therapy is used in primary treatment or in patients not responding to or recurrent after standard treatment. Six men with rapidly recurrent external and intraurethral condylomata acuminata underwent BCG therapy after initial laser treatment. External application and intraurethral instillation of BCG was performed six times in weekly intervals. Follow-up studies included examination and endoscopic inspection of the urethra and bladder. Three patients completed one course of BCG and had no relapse of condylomata acuminata. Two patients underwent a second course of BCG, of whom one relapsed. One patient relapsed after discontinued therapy due to penile edema. The annual recurrence rate decreased from 3.2 before the BCG therapy to 0.75 after BCG therapy (p<0.05, test of equality of 2 percentages). In addition, eight men underwent BCG therapy as primary therapy without initial laser treatment, following the same course of treatment, but employing BCG in a cream with salicylic acid to promote keratolysis. Six out of eight patients completely recovered. The BCG-induced immune response appears to reduce the recurrence rate in patients with condylomata acuminata.
Inventor(s):	Bohle; Andreas (D-23627 Gross Gronau, DE), Jocham; Dieter (D-23568 Lubeck, DE)
Assignee:
Application Number:	09/674,172
Patent Claims:	1. A method of treatment of condylomata acuminata in humans, which comprises: applying Bacillus Calmette-Guerin (BCG) to the affected area. 2. The method of claim 1 which comprises applying BCG to external and intraurethral condylomata acuminata. 3. The method of claim 1 which comprises applying BCG in about 1 to about 30 treatments to the affected area using an individual treatment dosage of from about 1 to about 500 mg of the BCG, wherein said applications are made at time intervals from about 1 to about 30 days where the applications number more than one. 4. The method of claim 1 which comprises performing ablative surgery to the affected area prior to said applying BCG. 5. The method of claim 4 wherein said ablative surgery is effected by laser. 6. The method of claim 1 which comprises formulating said BCG with a keratolytic agent for topical application to the affected area, and then topically applying said BCG to the affected area. 7. The method of claim 6 which comprises formulating BCG with a keratolytic agent for adherent application to the affected area, and then adherently applying said BCG to the affected area. 8. The method of claim 1 which comprises formulating said BCG with powdered salicylic acid as an adherent cream for application to the affected area, and then adherently applying said BCG to the affected area. 9. The method of claim 8 which comprises formulating said BCG with said salicylic acid in an amount of about 0.1 to about 50 wt % of the resulting formulation prior to said applying BCG to the affected area. 10. The method of claim 9 which comprises formulating said BCG said salicylic acid in an amount of about 1 to about 10 wt % of the resulting formulation prior to applying BCG to the affected area. 11. A therapeutic composition for the treatment of condylomata acuminate, comprising Bacillus Calmette-Guerin (BCG) formulated with a keratolytic agent for topical application to the affected area, wherein said keratolytic agent is powdered salicylic acid. 12. The composition of claim 11 wherein said salicylic acid is present in an amount of from about 0.1 to about 50 wt % of the composition. 13. The composition of claim 12 wherein said salicylic acid is present in an amount of about 1 to about 10 wt % of the composition. 14. A therapeutic composition for the treatment of condylomata acuminate, comprising Bacillus Calmette-Guerin (BCG) formulated with a keratolytic agent for topical application to the affected area, formulated with a keratolytic agent as a cream for topical adherent application to the affected area.

Details for Patent 6,896,888

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2040-01-28