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JP-7857360-B2 - Treatment of warts

JP7857360B2JP 7857360 B2JP7857360 B2JP 7857360B2JP-7857360-B2

Inventors

  • ジェイアール．エイチ．スチュアート、ニールセン

Assignees

  • ニールセン、バイオサイエンシズ、インコーポレイテッド

Dates

Publication Date
20260512
Application Date
20240823
Priority Date
20180806

Claims (20)

  1. A pharmaceutical composition for use in the partial disappearance of common warts, comprising two strains of Candida albicans and filtered extracts of secretory antigens of the two strains, wherein the pharmaceutical composition is administered to a subject having common warts by one or more intra-focal injections, a cumulative dose of 5-unit potency of the pharmaceutical composition is provided to the subject, the partial disappearance is identified by a reduction in the diameter of the warts, and the two strains of Candida albicans are deposited with the American Type Culture Collection (ATCC) under ATCC accession numbers PTA-126019 and PTA-126020.
  2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is further effective in reducing the diameter of the common warts by at least 50% with a cumulative dose of one unit potency of the pharmaceutical composition to the target.
  3. The pharmaceutical composition according to claim 1, wherein, prior to the administration, the verruca vulgaris is between approximately 3 millimeters (mm) and approximately 20 mm in size.
  4. The pharmaceutical composition according to claim 1, wherein the administration is the administration of the pharmaceutical composition by intra-focal injection into the target.
  5. The pharmaceutical composition according to claim 4, wherein the administration is the administration of one lesion by intra-focal injection of the pharmaceutical composition near the edge of the common wart.
  6. The pharmaceutical composition according to claim 4, wherein the administration is the administration of one lesion of the pharmaceutical composition to the margin of the common wart.
  7. The pharmaceutical composition according to claim 4, wherein the administration is the administration of one lesion of the pharmaceutical composition within the common wart.
  8. The pharmaceutical composition according to claim 1, wherein the administration is the administration of two or more intralesional injections of the pharmaceutical composition into the target.
  9. The pharmaceutical composition according to claim 8, wherein each of the two or more intralesional injections of the pharmaceutical composition is administered to the target at a dose of at least 0.5 unit potency of the pharmaceutical composition.
  10. The pharmaceutical composition according to claim 1, wherein the two or more intralesional injections of the pharmaceutical composition are administered to the subject over a single time period.
  11. The pharmaceutical composition according to claim 10, wherein one of the two or more intralesional injections of the pharmaceutical composition is administered to the subject at intervals of approximately two weeks.
  12. The pharmaceutical composition according to claim 10, wherein one of the two or more intralesional injections of the pharmaceutical composition is administered to the subject at intervals of approximately three weeks.
  13. The pharmaceutical composition according to claim 10, wherein the two or more intralesional injections of the pharmaceutical composition are administered to the subject for at least about 18 weeks.
  14. The pharmaceutical composition according to claim 8, wherein the two or more intralesional injections of the pharmaceutical composition are administered in subgroups of the two or more intralesional injections of the pharmaceutical composition over a single time period.
  15. The pharmaceutical composition according to claim 14, wherein one subgroup within the two or more subgroups of intralesional injection of the pharmaceutical composition provides a total dose of at least 0.5 unit potency of the pharmaceutical composition.
  16. The pharmaceutical composition according to claim 14 or 15, wherein one subgroup within the two or more subgroups of intralesional injection of the pharmaceutical composition is administered to the subject at intervals of approximately two weeks.
  17. The pharmaceutical composition according to claim 14 or 15, wherein one subgroup within the two or more subgroups of intralesional injection of the pharmaceutical composition is administered to the subject at intervals of approximately three weeks.
  18. The pharmaceutical composition according to claim 14 or 15, wherein two or more subgroups of intralesional injections of the pharmaceutical composition are administered to the subject for at least about 18 weeks.
  19. The pharmaceutical composition according to claim 14 or 15, wherein one of the two or more subgroups comprises two intralesional injections of the pharmaceutical composition around the common warts.
  20. The pharmaceutical composition according to claim 14 or 15, wherein one of the two or more subgroups comprises three intralesional injections of the pharmaceutical composition around the common warts.

Description

ATCC PTA-126019 ATCC PTA-126020 Cross-reference of related applications This application claims the benefits of U.S. Provisional Patent Application No. 62/714,942 filed on August 6, 2018, and U.S. Provisional Patent Application No. 62/880,742 filed on July 31, 2019, each of which is incorporated herein by reference in its entirety. This disclosure relates to a therapeutic agent having a standardized potency for the complete disappearance of verruca vulgaris and the prevention of recurrence of verruca vulgaris. Verruca vulgaris is a skin infection caused by the human papillomavirus (HPV). This virus initially targets epidermal basal cells, inducing hyperplasia and keratinization, which clinically manifests as verrucae. While verruca vulgaris is not life-threatening, it can cause both physical discomfort and embarrassment in patients. The overall prevalence of common warts (verruca vulgaris) in the United States is estimated to be between 2% and 20%. However, current treatment options for common warts vary in effectiveness and often result in recurrence. Treatments include topical salicylic acid, topical imiquimod, bleomycin injections, cryotherapy, excision, electrocautery, and laser vaporization, each with varying outcomes and side effects. Immunotherapy using Candida albicans antigen is also being studied. However, various response levels have been reported. Aldahan AS et al., “Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature,” Dermatological Therapy 2016;29:197-207, Table 1; and Aldahan A et al. See, “Use of Candida antigen injections for the treatment of verruca vulgaris: A two-year mayo clinical experience,” Journal of Dermatological Treatment 2016;27(4):355-58, 355, Table 2. The inconsistent results are thought to be due to the use of different Candida antigen sources in these studies, which clearly differ in concentration and titer. For example, two studies used Candida antigen obtained from Hollister-Stier (Aldahan et al. at 355 and Perman Me et al., “The painful purple digit: an alarming complexity of Candida albicans antigen treatment of recalcitrant warts,” Dermatitis: Contact, Atopic, Occupational, Drug 2005;16(1):38-40 (cited by Aldahan et al.)), and another study used Candida antigen obtained from Bayer (Johnson et al. al., “Internal injection of mumps or candida skin test antigens: a novel immunotherapy for warts,” Arch Dematol. 2001;137:451-55 (cited by Aldahan et al. and Alikhan et al.)), and another study used Candida antigen obtained from Creative Drug Industries (Majid I and Imran S, “Immunotherapy with Internal Candida Albicans Antigen in Resistant or Recurrent Warts: A Study, "Indian Journal of Dermatology 2013:58(5):360-65 (cited by Aldahan et al. and Alikhan et al.)," other studies have used Candin® manufactured by Allermed Laboratories (Kim KH et al., "Phase 1 clinical trial of intralesional injection of Candida antibody for the treatment of warts," Arch Dermatology 2010, 146(12):1431-33; Pfenninger JL and Fowler GC, “Procedures for Primary Care,” Third Edition, Elsevier 2010, 639-43; Signor RJ, “Candida albicans Intralesional Injection Immunotherapy of Warts,” Cutis 2002;70:185-92 (cited in Alikhan et al.); Phillips RC et al. , “Treatment of Warts with Candida Antigen Injection,” Arch Dematol 2001, 136(10):1274-5); Wong A and Crawford RI, “Internal Candida antigen for common warts in people with HIV,” J Cutan Med Surge. 2013;17(5):313-15 (cited in Aldahan et al.). Some studies do not report on the source of the Candida antigen. Summers Pet et al. , “Treatment of recalcitrant verruca vulgaris with Candida antigen in patient with human immunodeficiency virus,”J Drugs Dermatol 2009; 8(3): 268-69 (cited in Aldahan et al.); “Warts Refractory to Conventional Therapy Yield to Candida Antigen,” American Academy of Family Practice 90 Clinical Perspectives 1990; Harada S, “Clinical Application of Fungus Extracts and its Culture filtrate in the Treatment of Skin Diseases: (3) Candida Vaccine in the Treatment of Worts, "Japanese Journal of Dermatology 1979; 89 (6), 397-402. Therefore, considering the various sources being studied, the doses reported by volume and weight/volume (v/w) dilutions do not provide physicians with sufficient information to achieve consistent verrucae cure rates. At best, the administration of the antigen based on an early delayed-type hypersensitivity (DTH) response is shown in U.S. Patent No. 6,350,451 for Horn. See the examples in Patent No. 451. Therefore, a Candida antigen composition with a standardized potency for the treatment of verrucae is desired. This disclosure provides, and includes, compositions having a standardized potency for use in the treatment of one or more common or non-common warts. This disclosure also provides, and includes, methods for treating one or more common or non-common warts. In one embodiment, the present disclosure provides a method for treating ve