News 
Market Data 
Discover
Replies to post #199020 on Biotech Values
01/12/16 7:35 PM
02/03/16 9:25 AM
Under the terms of the Agreement, Stendhal will pay $10 million toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs.
Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.
03/16/16 4:20 PM
03/21/16 9:10 AM
The study by Nicola Mason, PhD, BVetMed, Associate Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, evaluated the immunogenicity, safety, and impact of attenuated, recombinant Listeria monocytogenes (Lm) transformed with a HER2/Neu fusion protein (ADXS-HER2) on survival in 18 dogs with surgically treated osteosarcoma.
…18 dogs received either 2x10^8, 5x10^8, 1x10^9 or 3.3x10^9 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group. The median survival time for the ADXS-HER2 treated dogs was 956 days which was significantly longer than the 423 day median survival time of the historical control group (p=0.014, HR 0.33; 95% CI 0.136-0.802).
06/07/16 10:31 AM
06/27/16 10:01 AM
07/06/16 11:05 AM
08/16/16 10:02 AM
10/04/16 10:56 AM
10/27/16 12:43 PM
Complete enrollment in the combination Phase 1/2 study with [AZN’s] durvalumab for the treatment of HPV-associated head and neck and cervical cancer in late 2016.
11/11/16 11:00 AM
This Phase 1 (Part A; 3+3) dose-escalation study was designed to assess the overall safety and select the recommended phase 2 dose (RP2D) of AXAL in combination with durvalumab in patients with recurrent/metastatic cervical or HPV+ HNSCC cancer. Patients received AXAL (1×10^9 colony-forming units [CFU]) every four weeks and durvalumab (3 mg/kg or 10 mg/kg) every two weeks.
Preliminary results from Part A dose escalation showed that there were no dose limiting toxicities observed, and the safety profile was consistent with previous findings for both AXAL and durvalumab. The recommended phase 2 dose was established as 1×10^9 CFU for AXAL and 10 mg/kg for durvalumab.
One patient with cervical cancer achieved a complete response, which remains ongoing after 12 months of follow-up, and one patient, also with cervical cancer, achieved a partial response with subsequent disease progression. In addition, two patients with HNSCC achieved stable disease. Treatment related adverse events (TRAE) were reported in 91 percent of patients; the majority were either grade 1 or grade 2 events such as chills, fever, nausea and hypotension. Grade 3 TRAEs occurred in three patients, and one patient experienced a grade 4 event.
