Monday, December 15, 2014
Anergis, a Swiss-based company developing proprietary ultra-fast allergy vaccines, has begun a phase II trial designed to finalize the dose selection for the phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.
Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck‘s FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.
Neurocrine Biosciences has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has entered clinical trials for the treatment of classic congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the U.S. The company has successfully completed a pilot clinical trial in adults with classic CAH and is initiating an open-label, single ascending dose trial in approximately 15 adolescent females with classic CAH, the 1401 Study.
The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.
The FDA has published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
CytRx, a biopharmaceutical R&D company specializing in oncology, has received notice from the FDA that its clinical trials for aldoxorubicin have been placed on partial clinical hold. All currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted.