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Osiris Therapeutics issued results of a single-blind, randomized, controlled multicentered trial of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients between ages 18 and 80 with type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were enrolled at 19 wound care centers across the U.S. and randomized to Grafix or control dressings at a 1:1 ratio. Ulcers had to be present for at least four weeks prior to randomization and be between one cm2 and 15 cm2 in size. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds—an improvement of 191%. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.
Adocia reported results from a phase IIa trial of Biochaperone PDGF-BB (Platelet Derived Growth factor) spray for the treatment of diabetic foot ulcers. The open label trial enrolled 192 subjects in four groups consisting in the application of one of the three doses of BioChaperone PDGF-BB spray (14.5, 43.75 and 87.5 micrograms of PDGF-BB per square cm and per week) and active comparator Regranex gel (43.5 micrograms per square cm and per week). BioChaperone PDGF-BB treatments were administered once every two days whereas Regranex was administered once a day. The treatment duration was 20 weeks or until complete healing. The primary endpoint was non-inferiority in the percentage of complete wound closure at 20 weeks. The endpoint was reached: the rates of complete wound closure are all superior or equal to 66% after 20 weeks. Biochaperone PDGF-BB was well tolerated and safe at the three doses tested.
Derma Sciences reported results from a phase II trial of DSC127 for the treatment of chronic diabetic foot ulcers. This US based, double-blind, placebo-controlled, multi-center study enrolled 80 subjects who receive one of two dose strengths of DSC127 (0.03% and 0.01%) or placebo. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those subjects randomized into the study received four weeks of active treatment followed by eight weeks of observation and assessment. The primary endpoint was the proportion of study ulcers healed by 12 weeks, as defined by 100% epithelialized with no drainage. In the Intent-to-Treat population results showed that 54% of the diabetic wounds treated with the 0.03% dose of DSC127 achieved 100% closure in 12 weeks or less, compared with 33% of the placebo group and 30% of the 0.01% dose group. In the Per-Protocol population results showed that 65% of the diabetic wounds treated with the 0.03% dose of DSC127 achieved 100% closure in 12 weeks or less, compared with 38% of the placebo group and 28% of the 0.01% DSC127 dose group. The drug was well-tolerated and there were no significant adverse events associated with DSC127 treatment.
Cardiovascular Biotherapeutics released results from a phase IIa and IIb trial evaluating CVBT-141B for the treatment of chronic ischemic diabetic wounds. In the phase IIa trial, diabetic wounds treated with CVBT-141B healed approximately 4.5 times faster than wounds treated with placebo or standard of care, including debridement. In the phase IIb trial, all of the diabetic wounds treated with CVBT-141B achieved 100% closure within five months or less, while one-third of the placebo-treated wounds remained open at the end of the same treatment period. In addition, 57% of subjects treated with CVBT-141B had complete closure of their diabetic wounds at eight weeks, versus 0% for the placebo group. Both trials demonstrated statistical significance to placebo (p<0.05).
Cardium reported positive results from a phase IIb trial of Excellarate for the treatment of diabetic foot ulcers. This randomized, double-blind, placebo-controlled, comparator arm clinical study, dubbed MATRIX, enrolled 124 subjects with non-healing diabetic foot ulcers who had failed standard therapy. The trial had five arms: standardized care comprising of surgical debridement, dressing changes, and weight off-loading devices, placebo single dose and double doses, and Excellarate single and double doses. The primary endpoint was complete ulcer closure at 12 weeks or earlier. A 55% relative improvement in achieving complete wound closure by 12 weeks was observed among subjects treated with a single dose of Excellarate as compared to those receiving standard of care. Complete wound closure occurred by 12 weeks occurred in 48% of subjects receiving a one-time treatment with Excellarate compared to 31% for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of subjects achieved complete closure by 12 weeks. Data also revealed that subjects receiving Excellarate exhibited early and rapid wound healing responses as evidenced by very substantial reductions in wound radius over the first several weeks following Excellarate administration. These responses were both greater and faster than those observed among subjects who had received standard of care.
Oculus released positive top-line results from a phase II trial of Dermacyn for the treatment of diabetic foot ulcers. This randomized, open-label three-arm study enrolled sixty-six subjects in the US. Subjects were randomized to receive Dermacyn, Dermacyn in combination with the oral antibiotic levofloxacin or saline plus oral levofloxacin. Treatment in each arm lasted for ten days, each time the wound dressing was changed. After ten days, subjects stopped treatment and returned two weeks later for a follow-up assessment. The primary endpoint was clinical cure or improvement of infection at day ten, defined as the elimination of all five of the Infectious Diseases Society of America visual symptoms that characterize mildly infected diabetic foot ulcers. At day ten in the Dermacyn monotherapy arm, a clinical cure or improvement rate of 75% was seen in fifteen subjects; 30% in six subjects and 45% in nine subjects. In the Saline plus Levofloxacin arm, a clinical cure or improvement rate of 57% was seen in twelve subjects; 33% in seven subjects and 24% in five subjects. In the Dermacyn plus Levofloxacin arm, a clinical cure or improvement rate of 64% was seen in sixteen subjects; 36% in nine subjects and 28% in seven subjects. At day twenty-four in the Dermacyn monotherapy arm, a clinical cure or improvement rate of 75% was seen in fifteen subjects; 55% in eleven subjects and 20% in four subjects. In the Saline plus Levofloxacin arm, a clinical cure or improvement rate of 52% was seen in eleven subjects; 29% in six subjects and 24% in five subjects. In the Dermacyn plus Levofloxacin arm, a clinical cure or improvement rate of 72% was seen in eighteen subjects; 44% in eleven subjects and 28% in seven subjects. Based on the results, Oculus planned to set up an end-of-phase II meeting with the FDA to discuss a phase III trial design.
Johnson and Johnson reported positive results from a phase III trial of ceftobiprole for the treatment of diabetic foot infections. This multi-center, double-blind trial enrolled 257 subjects with diabetic foot infections without concomitant osteomyelitis. The subjects were randomized to receive either 500 mg of ceftobiprole administered intravenously every eight hours or 1g of vancomycin administered intravenously every 12 hours plus 1g of ceftazidime administered intravenously every eight hours. Ceftobiprole was shown to clinically cure 86.2% of the infections, including those caused by methicillin-resistant Staphylococcus aureus, compared to an 81.8% cure rate seen with the combination treatment. Treatment was well tolerated, with an adverse event profile similar between the two groups. An NDA for ceftobiprole is currently under review by the FDA.
OrthoLogic reported positive results from a phase I/II trial of Chrysalin for the treatment of diabetic foot ulcers. This randomized, double-blind, placebo-controlled trial enrolled 60 subjects who received Chrysalin in saline or saline alone applied topically, twice weekly, to diabetic ulcers with standardized care and off-loading. Treatment was well tolerated with adverse events similar between the treatment groups. Chrysalin administered in 1 mcg and 10 mcg treatments resulted in 45% and 72% more subjects with complete healing than placebo treatment. In addition, when compared to placebo Chrysalin more than doubled the incidence of complete healing, increased the mean closure rate by 80% and decreased the median time to 100% closure by 40%. OrthoLogic is exploring partnership opportunities to help advance Chrysalin towards FDA approval for this indication.
Agennix reported positive results of a phase II study of their topical formulation of talactoferrin alfa, under investigation for the treatment of diabetic neuropathic ulcers. Safety data yielded positive results, with no drug- related adverse events noted and no incidence of infection of target ulcers during the dosing period. Primary efficacy data me their pre-specified endpoint, with subjects receiving the drug achieving 75% or better would healing roughly twice as often as subjects receiving placebo (p<0.05). This sequential-stage dosing study enrolled a total of 55 patients with diabetic neuropathic ulcers. Subjects enrolled in the open-label first stage received twice daily treatments with one of three doses of the drug (1%, 2.5% or 8.5%) for 30 days. In the randomized, placebo- controlled dosing stage, subjects received one of two doses of the drug (2.5% or 8.5%) or placebo in combination with good wound care for 12 weeks.
Bentley Pharmaceuticals announced positive results of a phase II trial of their investigational intranasal insulin, for the treatment of type 1 diabetes. Initial study results indicated that the intranasal formulation demonstrated more rapid absorption and higher peak plasma levels than injectable (subcutaneous) insulin. The drug achieved a calculated relative bioavailability of 15-20%, compared to established values for injectable insulin; this level is higher than those reported in most studies of inhaled insulin formulations. Furthermore, the drug successfully controlled post-prandial hyperglycemia for over two hours, indicating clinical utility. This open-label study enrolled 7 subjects with type 1 diabetes at a single site in Ireland. The company indicated that these initial results supported further development efforts in the near future.
Isis Pharmaceuticals announced positive interim results of a phase II study of ISIS 113715, their second generation antisense PTP-1B inhibitor for the treatment of type II diabetes. Efficacy data from the frist two dosing cohorts indicated that the drug produced a dose-dependent reduction in HbA1C from placebo at 6 weeks: it reduced HbA1C by 0.25% at the low dose (100 mg), and, 0.4% at the higher dose (200 mg). The drug also produced dose-dependent increases in the percentage of patients who achieved the target HbA1C level of 7%, with 33% and 45% of the patients respectively, vs. 25% of the patients in the placebo group. Finally, both doses were seen to reduce fasting plasma glucose by roughly 25mg/dL compared to placebo. This randomized, double-blind, placebo-controlled trial will eventually enroll patients into one of 4 weekly dosing regimens (100 mg, 200 mg, 400 mg and 600 mg) or placebo for 6 weeks. The company announced plans to initiate additional trials of the drug in combination with approved oral anti-diabetic agents later in 2005.
Merck reported combined results of three phase II trials of their investigational dipeptidyl peptidase IV inhibitor sitagliptin (MK-0431), for the treatment of type II diabetes. The pooled data indicated that the drug was efficacious in reducing hyperglycemia, with 12 weeks of treatment producing significant mean reductions in HbA1C levels compared to placebo for both once-and twice-daily dosing regimens. Furthermore, the addition of the drug to a standard regimen of metformin yielded improved 24 hour glycemic control vs. metformin alone, without increased incidence of adverse events. The first two studies were 12- week, randomized, double-blind, placebo-controlled trials: the first enrolled 552 patients into one of 5 dosing groups (25 mg, 50 mg, or 100 mg once daily, 50 mg twice daily, or placebo); the second enrolled 743 subjects into one of 6 groups (5 mg, 12.5 mg, 25 mg, or 50 mg sitagliptin twice daily, placebo, or the sulfonylurea glipizide 5 mg titrated to 20 mg daily). The third study was a randomized, double- blind, placebo-controlled, four-week crossover study, which evaluated the efficacy and tolerability of the addition of sitagliptin or placebo to a standard regimen of metformin.