|Jazz Pharma Presented Phase 2b Data for JZP-110 for Treatment of EDS Systems in Adults with Narcolepsy; Celldex Announces Varlilumab Continues to Show Very Favorable Profile|
|By Staff and Wire Reports|
|Monday, 02 June 2014 18:54|
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented data from the Phase 2b study evaluating JZP-110 (formerly known as ADX-N05) as a potential new treatment for the symptoms of excessive daytime sleepiness (EDS) in adults with narcolepsy. In the study, all primary and secondary endpoints were met and patients treated with JZP-110 experienced
statistically significant improvements in objective and subjective symptoms of E DS. Based on these data, Jazz Pharmaceuticals plans to evaluate JZP-110 in Phase 3 clinical studies in patients with EDS associated with narcolepsy and in patients with EDS associated with obstructive sleep apnea (OSA), pending discussions with regulatory agencies.
These data were presented today at a late-breaker session during SLEEP 2014, the 28th Annual Meeting of the Associated Professional Sleep Societies (APSS), in Minneapolis, Minn. The annual SLEEP meeting is the premier U.S. conference for healthcare professionals, advocates and industry partners involved in sleep medicine.
"We are committed to developing and commercializing new and differentiated therapies that address unmet patient needs in sleep medicine, and we believe, based on the encouraging results from early clinical trials, that JZP-110 has the potential to significantly help people with narcolepsy and OSA who are experiencing EDS," said Jeffrey Tobias, M.D., executive vice president, research and development, and chief medical officer, Jazz Pharmaceuticals. "As one of the newest additions to our growing sleep clinical development pipeline, we look forward to advancing the Phase 3 clinical program for this product candidate."
About the Study This Phase 2b, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the safety and efficacy of JZP-110 over 12 weeks in 93 subjects aged 18-70 years with an ICSD-2 diagnosis of narcolepsy. The study was sponsored by Aerial BioPharma, LLC, from which Jazz Pharmaceuticals acquired the rights to JZP-110 in early 2014. Subjects were randomized to once-daily placebo (n=49) or JZP-110 (n=44). JZP-110 was administered at a dose of 150 mg/day during weeks one through four and at a dose of 300 mg/day during weeks five through 12.
Co-primary efficacy endpoints measuring JZP-110's effect on EDS were change from baseline to last assessment in the length of time it took to fall asleep as measured by the average sleep onset latency (SOL) on the Maintenance of Wakefulness Test (MWT), an objective measure of the severity of EDS, and symptom improvement as measured by the Clinical Global Impression-Change (CGIC), a subjective physician-completed scale. The change from baseline at weeks four and 12 on the Epworth Sleepiness Scale (ESS), a subjective patient-completed measure of sleepiness, was a secondary endpoint.
Patients treated with JZP-110 experienced statistically significant results in both primary endpoints and the secondary endpoint (ESS) at weeks four and 12 compared to those receiving placebo.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today reported data from its ongoing Phase 1 study of the fully human monoclonal antibody varlilumab (CDX-1127) in cancer. Varlilumab is an immunotherapy designed to enhance the body's natural immune response by directly activating T cells that can specifically recognize and kill cancer cells. Preclinical data support the broad study of varlilumab in combination with a number of other anti-cancer agents including but not limited to checkpoint inhibitors, chemotherapies, targeted therapies and vaccines. Varlilumab will enter at least four combination studies in the second half of 2014.
Results presented included data from the lymphoid malignancies dose-escalation arm and solid tumor expansion cohorts in metastatic melanoma and renal cell carcinoma. Varlilumab was very well tolerated and demonstrated clear biologic activity and promising signs of clinical activity in advanced, treatment-refractory patient populations—all of which provide the rationale for combination studies with other immune activating therapies. Results were presented in two poster sessions (poster #16 and 19) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2014 on Monday, June 2, 2014 from 1:15 to 4:15 p.m. CDT. In addition, the data will be discussed during a Poster Highlight Session entitled "Modulating the Anti-tumor Immune Response" by Dr. Cassian Yee of The University of Texas MD Anderson Cancer Center today at 5:15 CDT.
"This first-in-man study for a CD27 agonist antibody documented significant immunological effects of varlilumab, most notably activation of T cells, including de novo responses to previously defined tumor antigens, and impressive decreases in regulatory cells—both of which have been shown to be necessary to generate optimal anti-cancer immune responses," said Tim Bullock, PhD, Associate Professor of Pathology, University of Virginia School of Medicine, who led the immune monitoring on the solid tumor arm of the Phase 1 varlilumab study. "Importantly, varlilumab was able to elicit these biological effects while also demonstrating a benign safety profile--suggesting that combination therapies involving varlilumab will not be limited by unacceptable toxicities. Moving forward, in these combination studies, it will be important to further elucidate how the dose and timing of varlilumab administration impact the biological and clinical effects so we can optimize clinical benefit for patients with cancer."
"Varlilumab's minimal toxicity and ability to specifically activate the immune system while acutely reducing measurable regulatory T cells make it an ideal agent to use with checkpoint inhibition and other anti-tumor approaches," said Tom Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "We are focused on the initiation of an expanded combination program with internal programs and external collaborators, including several checkpoint inhibitors and other molecularly targeted agents. We believe varlilumab has significant potential and these studies will further add to our understanding of this program."
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