In a release, the Company noted:
BL-5010P is a disposable, pen-like applicator containing BL- 5010, a novel aqueous solution, which is an alternative to painful, invasive and expensive removal treatments such as cryotherapy, laser treatment or surgery. The primary objective of the single-arm, open- label, pivotal bridging study is to assess the efficacy of a single application of BL-5010 in the removal of seborrheic keratosis (SK) lesions.
"We are very pleased to have received approval from the German authorities to commence a pivotal bridging study for BL-5010P. This important approval reaffirms that BL-5010P will be developed and regulated in
About BL-5010 and BL-5010P
BL-5010is a novel aqueous formulation, composed of approved components, for the non-surgical removal of benign skin lesions such as seborrheic keratosis.BL-5010 offers an alternative to painful, invasive and expensive removal treatments including cryotherapy, laser treatment and surgery. Because the treatment is non-invasive, it poses minimal infection risk andeliminates theneed for anesthesia or bandaging. The formulation is applied topicallyto the lesion for a few seconds and causes the lesion to gradually dry out and fall off within one to four weeks.BL-5010P is a disposable, non- invasive, pen-like applicator containing the BL-5010 solution. Both BL-5010 and BL-5010P have received confirmation in
A Phase 1/2pilot study, performed on 60 patients with SK, demonstrated that a single, topical application of BL-5010 was effective in 97 percent of cases for removal of the target lesion within 30 days. In addition, the treatment was well-tolerated and no persistent irreversible adverse effects were observed at the treated site. Furthermore, cosmetic outcomes were highly rated by both patients and investigators. BL-5010 was invented by Prof.
Seborrheic keratosis (SK) is a very common, benign skin lesion that commonly appears during adult life. Patients with SK often request treatment due to symptoms of itching and irritation, or due to cosmetic reasons. Such lesions can be painful and also tend to become injured and sometimes bleed and/or become infected. Actinic keratosis (AK) is a pre-cancerous skin condition that appears as a dry, scaly, sometimes hyperkeratotic lesion caused by prolonged and repeated sun exposure. AK is the most common pre-cancerous skin lesion and treatment of AK is the most frequent dermatologic procedure performed in out-patient clinics. At present, skin lesions that are not suspected to be malignant are treated by methods such as cryotherapy, laser therapy, or electro-cauterization. Such treatments often lead to complications that include pain, bleeding and discharge, as well as infection, blistering and hematoma. These complications commonly necessitate the application of localized antibiotics as well as bandaging, are liable to cause further discomfort to the individual treated, and the healing process is liable to be slow and prolonged, and may lead to scarring. Furthermore, cryotherapy, laser therapy, and electro-cauterization destroy the treated skin region, making histopathological diagnosis of the skin lesions impossible. The total AK and SK market is estimated at over
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In a release, the Company noted: