A Phase II Multicenter, Randomized, Double Blind Study to Assess the Safety, Tolerability and Efficacy of Two Concentrations of ZEP-3Na Topical Cream (0.1% and 1%) Compared to Vehicle-control in Subjects With Mild to Moderate Atopic Dermatitis With an Open Label Extension of up to 2 Weeks Treatment With ZEP-3Na Topical Cream 1%
This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. patients that will reach the primary endpoint will have the opportunity for additional to two weeks of open label treatment with ZEP-3Na 1%. The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.
A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes Labialis).
This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers. This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel. The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
Just less than a year ago, Gilead’s Kite won a landmark okay for its second CAR-T therapy, with data that former head of global development Ken Takeshita hailed as “better than Yescarta.” Now, ahead of #ASCO21, Kite is unveiling pivotal data to back the drug in a new type of cancer.
Of 55 patients who received Tecartus for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), 71% saw their signs of cancer disappear, new head of clinical development Frank Neumann said. However, some still had incomplete hematologic recovery (which the company defined as complete response with incomplete hematologic recovery, or CRi).
Thirty-one percent of these patients saw ongoing responses at the data cutoff, Kite said, and 97% had deep molecular remission with undetectable minimal residual disease.
“This patient population in particular has a very hampered hematopoietic system,” Neumann told Endpoints News. “I would say, for a patient reaching CRi in this particular indication, it’s fantastic, to say the least.”
The data come from a primary analysis of the Phase II portion of Kite’s open-label ZUMA-3 trial. Just under half of the treated patients had received three or more therapies prior to Tecartus, and among the 25 who had taken the immunotherapy blinatumomab, the complete response rate was a bit lower, coming in at just 60%.
Across the whole treatment arm, median duration of response, relapse-free survival and overall survival were 12.8 months, 11.6 months and 18.2 months, respectively.
The FDA gave Tecartus priority review for the indication last Friday, and set a PDUFA date of Oct. 1. If approved, CEO Christi Shaw says the company could start rolling out the drug in days.
The treatment comes with some risk, as 95% of patients experienced Grade 3 or higher adverse events, the most frequent being anemia and pyrexia, or fever. Grade 3 or higher cytokine release syndrome — a well-documented side effect of CAR-T therapy — occurred in 24% of patients. Neurologic events happened in 25%, Kite said.
CRS and neurologic toxicities earned Tecartus a boxed warning in relapsed/refractory mantle cell lymphoma, though researchers saw lower cases of Grade 3 or higher CRS in that study than in ZUMA-3 (18% compared to 24%). CRS cases in Zuma-3 were “generally reversed with treatment,” Kite said in a statement.
Two treatment-related deaths occurred in ZUMA-3, including one brain herniation and one case of septic shock, according to Kite’s statement.
“The safety profile of Tecartus in this particular indication doesn’t differ significantly from what we’ve seen in other indications,” Neumann said.
Upon its approval last year, a Kite spokesperson told Endpoints that the drug would be sold for $373,000. Since then, the list price has increased to just under $400,000, Shaw said. Tecartus brought in $31 million in Q1, as launch activities ramped up in the US, according to Gilead’s financial results.
“As long as we have these really long durable responses, and we can manufacture consistently, and continue with Frank’s leadership developing new therapies that help increase the benefit/risk for patients, I think that’s the secret sauce,” she said.
While ZUMA-3 enrolled patients 18 years and older, Novartis’ CAR-T rival Kymriah is already approved to treat relapsed/refractory ALL in patients 25 years old and younger, and it’s currently in a Phase III trial for high-risk ALL in the same population.