IP Library Granted Patent US 12,708,791
Granted Patent B2
US 12,708,791 · App. 17/913,741 · Granted Aug 18, 2026

Management of dermal neurofibromatosis lesions

Inventors: Harry Thomas Whelan (Whitefish Bay, WI); Brendan John Quirk (Mayville, WI); Edit Olasz Harken (Pewaukee, WI)
Assignee: Sun Pharmaceutical Industries, Inc.
A61N5/062A61N5/0616A61P35/00A61N2005/0651A61N2005/0663
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,708,791
App. No.
17/913,741
Filed
Sep 22, 2022
Granted
Aug 18, 2026
Kind
B2
Art Unit
3792
USPC
606/9
Abstract

Dermal neurofibroma, in particular Neurofibromatosis Type I (NF1) leads to progressive tumor proliferation with no known mechanism to inhibit growth. The present invention relates to the use of photodynamic therapy (PDT) for attenuating tumor growth in NF1 patients. More particularly the invention provides a method of treating dermal neurofibroma comprising topically applying a pharmaceutical composition comprising a photosensitizer to the affected area of a patient, incubating the affected area, and irradiating the affected area with a light of suitable wavelength as per the photosensitizer used, wherein the treatment is characterized by inhibiting the progression of tumor growth and/or reduction in tumor size and/or increased mortality rate of the neurofibroma cell.

Claims (15)

1 . A method of treating dermal neurofibroma in a patient comprising:

a. topically applying a pharmaceutical composition comprising a photosensitizer to an affected area of the patient,

b. microneedling the affected area before and/or after topical application of the photosensitizer,

c. incubating the affected area, and

d. irradiating the affected area with blue light;

wherein the treatment is effective to inhibit progression of neurofibroma tumor growth and/or achieve a reduction in neurofibroma tumor size and/or achieve an increased mortality rate of neurofibroma cells.

2 . The method according to claim 1 , wherein the pharmaceutical composition comprises 5-aminolevulinic acid as the photosensitizer.

3 . The method according to claim 1 , wherein the pharmaceutical composition comprises about 10% w/v to about 20% w/v of 5-aminolevulinic acid as the photosensitizer.

4 . The method according to claim 1 , wherein the wavelength of the blue light is in the range 410 nm to 485 nm.

5 . The method according to claim 1 , wherein the wavelength of the blue light is 417 nm±5 nm.

6 . The method according to claim 1 , wherein the blue light is applied at an intensity of 10 mW/cm 2 for 1000 seconds to provide a total applied dose of 10 J/cm 2 .

7 . The method according to claim 1 , wherein the blue light is applied at an intensity of greater than 10 mW/cm 2 for less than 1000 seconds at a total applied dose of 10 J/cm 2 .

8 . The method according to claim 1 , wherein the increased mortality rate of neurofibroma cells is determined by appearance or detection of increased DNA fragmentation.

9 . The method according to claim 1 , wherein the treatment further comprises a step of degreasing of the affected area before topical application of the photosensitizer.

10 . The method according to claim 1 , wherein the blue light is applied at a dose of 20 J/cm 2 .

Assignments (2)
MERGER Recorded May 30, 2024
From: DUSA PHARMACEUTICALS, INC.
To: SUN PHARMACEUTICAL INDUSTRIES, INC.
Reel/Frame 067565/0986 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2022
From: WHELAN, HARRY THOMAS; QUIRK, BRENDAN JOHN; HARKEN, EDIT OLASZ
To: DUSA PHARMACEUTICALS, INC.
Reel/Frame 061190/0126 →
Continuity (2)
Provisional Application 63000317 · Mar 26, 2020
Related Publication 20230035733A1 · Feb 2, 2023
References Cited (27)
US 6223071B1 · Lundahl et al. · 2001 [cited by applicant]
US 6709446B2 · Lundahl et al. · 2004 [cited by applicant]
US 7190109B2 · Lundahl et al. · 2007 [cited by applicant]
US 7723910B2 · Lundahl et al. · 2010 [cited by applicant]
US 8030836B2 · Lundahl et al. · 2011 [cited by applicant]
US 8216289B2 · Lundahl et al. · 2012 [cited by applicant]
US 8758418B2 · Lundahl et al. · 2014 [cited by applicant]
US 20040266989A1 · Currie et al. · 2004 [cited by applicant]
US 20060251668A1 · Goletz et al. · 2006 [cited by applicant]
US 20090118240A1 · Chen · 2009 [cited by examiner]
US 20090214560A1 · Min et al. · 2009 [cited by applicant]
US 20150216830A1 · Rephaeli et al. · 2015 [cited by applicant]
US 20160082241A1 · Burton · 2016 [cited by examiner]
US 20170304654A1 · Blanche · 2017 [cited by examiner]
WO WO2013120497A1 · 2013 [cited by applicant]
WO WO2017066270A1 · 2017 [cited by applicant]
Gupta et al (Gupta, J. Ryder, “Photodynamic Therapy and Topical Aminolevulinic Acid,” Am. J. Clin. Derm. 4, 699-708 (issued Oct. 2003), as published Aug. 21, 2012. [cited by examiner]
B. Quirk, E. Olasz, S. Kumar, D. Basel, H. Whelan, “Photodynamic Therapy for Benign Cutaneous Neurofibromas Using Aminolevulinic Acid Topical Application and 633 nm Red Light Illumination,” Photobiomodulation, Photomedi… [cited by applicant]
S. Frustaci et al., Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: results of the Italian randomized cooperative trial, J Clin. Oncol, Mar. 2001; 19: 1238-47. [cited by applicant]
A. Gupta, J. Ryder, “Photodynamic Therapy and Topical Aminolevulinic Acid,” Am. J. Clin. Derm. 4, 699-708 (issued Oct. 2003), as published Aug. 21, 2012. [cited by applicant]
S. Huson et al., Von Recklinghausen neurofibromatosis: a clinical and population study in south-east Wales, Brain Dec. 1988; 111: 1355-81. [cited by applicant]
M. Lammert, J. Friedman, L. Kluwe, V. Mautner, Prevalence of Neurofibromatosis 1 in German Children at Elementary School Enrollment, Arch. Dermatol. Jan. 2005; 141: 71-74. [cited by applicant]
Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1), H. Whelan, NCT01682811, ClinicalTrials.gov, Sep. 11, 2012, Results posted Jun. 18, 2021, accessible via https://clinicaltrials.gov/ct2/show/NCT01… [cited by applicant]
Sarcoma Meta-analysis Collaboration (SMAC), Adjuvant chemotherapy for localised resectable soft tissue sarcoma in adults, Cochrane Database Syst Rev 2000; 4: CD001419. [cited by applicant]
V. Riccardi, B. Quirk, E. Olasz, S. Kumar, D. Basel, H. Whelan, “Photodynamic Therapy for Benign Dermal Neurofibromas,” Children's Tumor Foundation conference material, May 2019 (1 page). [cited by applicant]
David H. Gutmann et al., The Diagnostic Evaluation and Multidisciplinary Management of Neurofibromatosis 1 and Neurofibromatosis 2, J.A.M.A., vol. 278, No. 1, Jul. 2, 1997, pp. 51-57. [cited by applicant]
International Preliminary Report on Patentability and Written Opinion, International Application No. PCT/IB2021/052535, Report issued Sep. 22, 2022 (6 pages). [cited by applicant]