Therapeutic Areas

Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) together make up the non-melanoma skin cancers (NMSC) and are the most common cancers in white individuals1. Since NMSC commonly occur in sun damaged skin, the scalp, face, ears, lips, and upper extremities are the most common areas of the body involved. Unlike BCC that tends to invade local tissues, cSCC has a substantial risk of metastasis and most often arises from a skin disease called actinic keratosis2 (AK).

AK is one of the most common dermatologic diagnoses. It effects an estimated 58 million people in the United States alone with estimated treatment costs in 2004 of $1.2 billion3. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC4. Thus, although most people seek medical care for simple cosmetic reasons, treatment is most commonly recommended by physicians in order to prevent cSCC.

Current AK treatments have significant limitations. Individual lesions are most often treated with cryotherapy (liquid nitrogen). However, since AK results from malignant processes that occur in ‘fields’ of sun-exposed skin, recurrence is high if the entire field is not treated.

The most common field treatments of AK5 may be divided into two groups based upon efficacy and side effects. One group, including 5-fluorouracil, imiquimod, ingenol mebutate, photodynamic therapy, and chemical pealing or dermabrasion are effective at least temporarily, but induce significant local side effects including pain, swelling, redness, flaking, and/or even ulcers. The second group includes topical medications with fewer local side effects but considerably longer treatment courses. Examples include: (1) diclofenac plus hyaluronic acid that requires twice daily treatment for 2-3 month and whose percent remissions beyond 1 year is unknown6; and (2) retinoid treatment whose efficacy is controversial.

AK is a chronic disease for which patients often require repeat treatments. The limited tolerability or long treatment courses associated with the current treatments greatly decreases the willingness of patients to be retreated and/or compliance. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors. In short, current therapies are inadequate and pose significant disadvantage to public health.

VDA-1102 ointment is the first in a new class of AK drugs that is expected to offer significant benefits for patients suffering from AK.

  1. Leiter U, Eigentler T and Garbe C (2014). Epidemiology of Skin Cancer. Adv Exp Med Biol 810:120-40.
  2. Mittelbronn et al (1998). Frequency of pre‚Äźexisting actinic keratosis in cutaneous squamous cell carcinoma, International Journal of Dermatology 37(9): 677-681.‏
  3. Warino L. et al. (2006). Frequency and cost of actinic keratosis treatment, Dermatologic Surgery 32(8):1045–1049.
  4. Röwert-Huber J. et al. (2007). Actinic keratosis is an early in situ squamous cell carcinoma: a proposal for reclassification. British Journal of Dermatology 156(s3): 8–12.

Fact Box

                                                               Therapeutic Areas forward