|Oncothyreon And Celldex Therapeutics Announce Initiation Of Immunotherapy Clinical Trials; NPS Initiates Study of Teduglutide|
|By William Kent|
|Monday, 10 November 2014 20:09|
Oncothyreon Inc. (Nasdaq: ONTY) and Celldex Therapeutics, Inc., (Nasdaq: CLDX) announced they have initiated a combined clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.
ClinicalTrials.gov: NCT02270372 is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses, T-cell activation markers and levels of regulatory T-cells, and anti-tumor effects.
The Phase 1b trial will be conducted by Oncothyreon under the terms of a previously announced collaboration agreement between Oncothyreon and Celldex. The two companies will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together. Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced the company has initiated a global registration study of teduglutide in pediatric patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
The 12-week, open-label study evaluating teduglutide will be conducted at sites throughout the US and Europe. The primary outcome measures are the number of reported adverse events and changes in parenteral and enteral support requirements, respectively. Additional information about the trial, including a detailed listing of study sites, is available at the National Institutes of Health’s clinical trial registry, which can be found here: http://clinicaltrials.gov/show/NCT01952080
“We are particularly proud to advance teduglutide in pediatric Short Bowel Syndrome, as it may bring us one step closer to fulfilling a significant unmet need among children across the globe who face a life burdened by this rare disease,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “We look forward to reporting top line results following the completion of the study in late 2014 or early 2015.”
The four-cohort study is expected to enroll up to 36 patients. Non-randomized subjects will receive teduglutide in each of the three active cohorts for 12 weeks. The study will attempt to enroll a fourth cohort of patients in an observational arm that would receive a current standard of care with parenteral support and will be considered a safety control group. All subjects will be screened prior to the start of treatment to establish baseline characteristics including safety, eligibility and nutritional support parameters. Eligibility includes a current history of SBS for a minimum of 12 months prior to screening, which resulted from a major intestinal resection and SBS requiring stable administration of parenteral support for a minimum of three months prior to enrollment, based upon the opinion of the investigator.
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