New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
May 13, 2014
07:33 EDTNBSNeoStem announces licensing agreement, plans to begin Phase 2 HCC trial in China
NeoStem announced that the company has signed an exclusive license agreement with China-based Cellular Biomedicine Group to begin a Phase 2 clinical trial in patients with late stage liver cancer. The trial, to be conducted in China in accordance with international standards, will investigate the use of the Company's developmental patient-specific cancer immunotherapy known as "DC-TC", in patients with hepatocellular carcinoma, or HCC. Pursuant to the terms of the license agreement, the cost of the Phase 2 trial will be borne by CBMG, and CBMG will also be responsible for all clinical, marketing, and, should a product be approved, commercialization activities in China. NeoStem will be responsible for all regulatory filings and will directly control and manage all manufacturing processes and procedures relating to the development of its DC-TC product. NeoStem could receive up to $30M in licensing milestone fees over the life of the agreement, with $1M payable upon enrollment of the first patient in the currently planned Phase 2 trial. Royalties and sublicense fees may also be payable. The company's DC-TC therapy involves growing cancer initiating cells that have been isolated from a patient's resected tumor sample, and then enriching and inactivating them. This newly created cancer initiating cell line is then combined with dendritic cells, a type of antigen-presenting immune cell that is derived from the same patient's blood. The product is then reintroduced to the patient via a series of subcutaneous injections. The planned study follows a Phase 1 trial which demonstrated safety in HCC patients. There were no serious adverse events related to the treatment in patients who co-presented with active hepatitis B and underlying cirrhosis, commonly associated with liver cancer in China, and patients were not charged for treatment.
News For NBS From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 25, 2015
07:16 EDTNBSPiper Jaffray and the Alliance for Regenerative Medicine co-host conference
3rd Annual Regenerative Medicine Investor Day is being held in New York on March 25 with webcasted company presentations to begin at 8 am; not all company presentations may be webcasted. Webcast Link
March 20, 2015
07:42 EDTNBSBioCentury to hold a conference
Subscribe for More Information
March 16, 2015
06:05 EDTNBSNeoStem announces PreSERVE AMI clinical trial one-year follow up results
NeoStem announced the presentation of updated efficacy and safety results from the one-year follow-up for its Phase 2 PreSERVE study and additional analyses of certain functional tests at ACC.15, the American College of Cardiology's 64th Annual Scientific Session and Expo, in San Diego, California. The one-year follow-up results are defined as all data accumulated until the last patient enrolled completed 12 month follow-up. Thus, the results actually represent data from patients with a median follow-up of 18 months. The PreSERVE study is NeoStem's clinical trial evaluating NBS10 which is being developed to treat damaged heart muscle following an acute myocardial infarction. One-year follow-up safety data collected thus far supports the trial's 6 month results presented at the American Heart Association's Scientific Sessions in November 2014. The ACC presentation contained updated safety and exploratory efficacy data and additional analyses conducted on left ventricular ejection fraction, or LVEF, data. Clinical Endpoint Committee adjudication of major adverse cardiac events, or MACE, was performed on the 6 month data reported previously and was not performed for new events. The next prescribed adjudication of MACE is currently planned at the end of patient follow-up. At 12-month follow-up, no meaningful safety or tolerance differences were observed between treatment and control groups. In this updated analysis, no additional deaths were reported in the treatment or control groups beyond those previously reported in the six month analysis. In addition, in post hoc subset analyses based on the number of cells patients received, serious adverse event frequency continues to show numerical improvement at all cell doses when compared to control.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use