February 13, 2017
Biofrontera reported results of a phase III trial of BF-200 ALA (Ameluz) in combination with daylight photodynamic therapy (PDT). The intra-individual, randomized, observer-blind, multicenter study was performed with 52 patients at seven centers in Spain and Germany. Every patient had three to nine mild to moderate AK lesions in each of two comparable treatment areas on the face and/or scalp. For an intra-patient comparison of the treatments, each patient received daylight-PDT with BF-200 ALA on one side, and MAL on the other side. The study will be followed by assessments of lesion recurrence six and 12 months after daylight PDT. The study met its primary endpoint, resulting after a single daylight PDT in 79.8% total lesion clearance rate per patient’s side in the areas treated with BF-200 ALA and daylight PDT, compared to 76.5% total lesion clearance in areas treated with MAL and daylight PDT. For comparison, the much larger study ALA-AK-CT002, which compared the two products and demonstrated superiority of BF-200 ALA over MAL, resulted in lesion complete clearance rates after the first PDT with narrow-spectrum lamps of 77.1% with BF-200 ALA and 73.0% with MAL, respectively. These results will be employed for the filing of the EU label extension, which Biofrontera plans to submit in the second quarter of 2017.
December 14, 2009
Biofrontera issued preliminary results from a phase III trial of BF-200 ALA for the treatment of actinic keratosis. This placebo-controlled comparator study enrolled 570 subjects in Germany, Austria, France and Switzerland. The subjects received BF-200 ALA, the comparator Metvix or placebo. The superficial actinic keratosis tumors were covered with one of the two drugs, followed by an illumination with red light for a few minutes. The tumors were examined three months later, if residual keratoses were still present at this time point, the treatment was repeated. The tumors were examined again three months later. This treatment regimen was followed by a 12-month post-treatment observation period. The results show that in the BF-200 ALA arm, 78% of the subjects were totally cleared from all actinic keratoses tumors, compared to total clearance rates of 64% for the Metvix comparator arm and 17% for the placebo arm. The incidence adverse events were similar between the treatment arms.
January 12, 2009
Peplin issued positive results from a phase IIb trial of PEP-005 for the treatment of actinic keratosis (AK). This eight-arm, multi-center, randomized, double blind, placebo controlled trial, dubbed PEP005-015, enrolled 240 subjects with actinic keratosis lesions on the face and scalp, in the US and Australia. The subjects were randomized into either a two day or three day treatment regimen. Three concentrations (0.005%, 0.010% or 0.015%) or placebo were applied to a 25 cm2 treatment area containing four to eight AK lesions. The primary endpoint was the complete clearance rate of AK lesions. Four out of the six treatment groups achieved statistically significant clearance of AK lesions compared to placebo. The complete clearance rates ranged from 15.6% to 42.3% across the six active treatment groups. In the highest dose group, (0.015% PEP005 Gel for three consecutive days) the complete clearance rate was 42.3% (p≡0.005 versus placebo) and the median reduction in lesion count was 84.5%. At all concentrations, for both treatment regimens, the PEP005 Gel demonstrated a favorable safety profile and was well tolerated. No drug-related serious adverse events were reported. Phase III trials of PEP-005 are currently underway.
January 5, 2009
Biofrontera reported positive preliminary results from a phase III trial of BF-200 ALA-gel for the treatment of actinic keratosis. This placebo-controlled, double-blind study enrolled 122 subjects in Germany. The subjects received photodynamic therapy with BF-200 ALA or a placebo gel, administered to four to eight affected areas of the skin. Three hours later, these areas were exposed to red-light for 15 minutes and the tumor cells in the skin were removed. The success rate was assessed 12 weeks after treatment and, if necessary, treatment was repeated. Of the subjects treated with BF-200 ALA, 69% had a complete response (removal of all actinic keratoses in the area of investigation) compared to 13.5% of the subjects treated with placebo (<0.0001). Following a single treatment, 47.5% of subjects treated with BF-200 ALA had lesions which completely disappeared compared to 10% of those treated with placebo (p<0.0001). Treatment was generally well tolerated. Based on the results, Biofrontera plans to move ahead with the development of BF-200 ALA gel.
January 7, 2008
Peplin announced positive results from a phase IIa trial of PEP005 for the treatment of actinic keratosis. This open-label, dose escalation trial, dubbed PEP005-007, enrolled subjects in Australia and New Zealand. Topical PEP005 was applied to a 25 square centimeter infected area on the face or scalp, at strengths from 0.0025% to 0.025%, on either two or three consecutive days. The maximum tolerated dose was determined to be 0.025% applied daily for two consecutive days. Treatment safe and well tolerated. In addition, the two and three day course of PEP005 demonstrated complete and partial clearance of AK lesions in some subjects tested at each formulation strength, with the exception of the lowest strength, which demonstrated partial clearance in some subjects and no complete clearance. Based on the results, Peplin plans to continue with the development of PEP005.
July 30, 2007
Peplin announced positive preliminary results from a phase IIb trial of PEP005 for the treatment of actinic keratosis. This randomized, double-blind, double-dummy, placebo-controlled trial enrolled 222 subjects who were placed into one of four cohorts. The cohorts consisted of 0.025% PEP005 on days 1, 2 and 3; placebo on day 1 and 0.05% PEP005 on days 2 and 3; 0.05% PEP005 on days 1, 2 and 3 and placebo on days 1, 2 and 3. Treatment was administered to a 25 cm2 treatment area once daily. The primary endpoint was Partial clearance rate (PCR) defined as 75% or greater reduction in the number of AK lesions at day 57 compared to baseline. Secondary endpoints included complete AK lesion clearance rate (CCR) and baseline AK lesion clearance rate (100% CR). Statistically significant lesion clearance was reported at all PEP005 doses tested. On the primary endpoint , 75% of subjects in the highest dose group and 56% of the subjects in the lowest dose group cleared three quarters or more of their lesions (p<0.0001 and p=0.0002, respectively). Statistical significance was also reached on all secondary endpoints. Based on the results, Peplin plans to meet with the FDA to discuss a phase III trial design.
July 16, 2007
BioFrontera released positive results from a phase IIb/III trial of BF-200 ALA for the treatment of actinic keratosis. This placebo-controlled, randomized, double-blind study enrolled 105 subjects in Germany. The subjects were treated once by photodynamic therapy with one of three different BF-200 ALA concentrations or placebo, for 12 weeks. The primary endpoint was the percentage of the complete remission of actinic lesions. Results showed the 10% dose of BF-200 ALA was superior to the other doses tested, with 60-70% of the treated lesions cleared by week 12. Treatment was well tolerated, with no relevant side effects reported. Based on the results, BioFrontera plans to initiate future trials.
March 10, 2003
3M Pharmaceuticals reported positive results from two phase III trials investigating Aldara, an immune response modifier for the treatment of multiple actinic keratoses (AK) and superficial basal cell carcinoma (BCC). In the AK trial, median percent reduction in the number of lesions at baseline was 83 % in the treatment group versus 0 % in the placebo group. The complete clearance of lesions was observed in 45 % of subjects in the treatment group versus 3 % in the placebo group. The double blind, randomized, vehicle controlled trial enrolled 436 subjects with AK. Subjects were administered Aldara or vehicle cream two times per week for 16 weeks. In the BCC trial, results showed a histological clearance rate of 82 % compared to 3 % with placebo. The data also indicated an optimal dosing of five times per week. The double blind, randomized, placebo-controlled trial enrolled 724 subjects with superficial BCC. Subjects were treated either five or seven times per week for six weeks.