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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.
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March 2, 2015
16:09 EDTNBSNeoStem provides 2015 outlook
In 2015, NeoStem's management expects significant additional achievements. The Company's milestones and goals for the year include: Randomization of the first patient for the Intus Phase 3 trial for NBS20 in the second quarter of 2015; Release of one-year data from PreSERVE AMI Phase 2 trial for NBS10 on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology; Finalization of decision on next development steps for NBS10 based on PreSERVE primary analysis results in the second half of 2015; Initiation of a Phase 2 study for which NeoStem has received FDA agreement on the protocol to evaluate in adolescents the use of NBS03D, a Treg-based therapeutic being developed to treat type 1 diabetes, in late 2015 or 2016 depending on resource availability; Further exploration of means by which the Company can take advantage of new regulations in Japan that permit conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy; Continued growth of the Company's client services business; Advancement of initiatives to lower costs and improve efficiency of manufacturing in anticipation of production for NeoStem's own products and those of its clients.

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