Tuesday, May 13, 2014 5:28:22 PM
NeoStem, Inc. (NASDAQ:NBS)
Today : Tuesday 13 May 2014
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, announced today that the Company has signed an exclusive license agreement with China-based Cellular Biomedicine Group (OTCQB:CBMG) ("CBMG") 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 ("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 $30 million in licensing milestone fees over the life of the agreement, with $1 million 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 (stem) cells that have been isolated from a patient's resected tumor sample, and then enriching and inactivating them. This newly created cancer initiating (stem) 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. "We were very pleased to have concluded a Phase 1 trial with positive safety outcomes and look forward to continuing to work to develop this treatment in a country where so many people are greatly affected by this disease," said Dr. Hans Keirstead, President of NeoStem Oncology, LLC, the Company's wholly-owned subsidiary developing targeted immunotherapies for cancer treatment. "Patients with this stage of disease are not eligible for curative resection or transplantation."
"The planned Phase 2 study in China is seeking to assess the efficacy and safety of our new DC-TC platform technology in treating hepatocellular carcinoma, and we look forward to working with CBMG to develop this indication in Asia," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "China holds more than 45% of the world's HCC patients, being responsible for 395,000, or roughly 50%, of new cases in 2012."
The Company has also recently reached agreement with the U.S. Food and Drug Administration to begin a Phase 3 clinical trial for its lead product candidate, Melapuldencel- T, in metastatic melanoma, expected to begin in 2014. Melapuldencel-T's Phase 3 protocol has been granted Special Protocol Assessment ("SPA") and the product candidate has received Fast Track designation for metastatic melanoma, as well as Orphan Drug designation. Five year survival data from the Phase 2 clinical trial in metastatic melanoma has been accepted for a poster presentation at The American Society of Clinical Oncology's 2014 annual meeting in June.
About the DC-TC Treatment
The Company's DC-TC treatment is based on recent clinical findings that the rapid proliferation and subsequent spreading of cancer throughout a patient's body may be fueled by a small number of cancer initiating (stem) cells. Through proprietary processes, our researchers have refined isolation and expansion of these cancer initiating (stem) cells to clinically useful numbers, which are then combined with autologous dendritic cells, and reintroduced into the patient with the intention of training and bolstering the patient's immune system to target the cancer stem cells that have the ability to metastasize and create new tumors.
About NeoStem
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's ability to consummate the CSC acquisition and the Company's ability to develop and grow its business, the successful development of cellular therapies (including in hepatocellular carcinoma) with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Targeted Immunotherapy Program, CD34 Cell Program and T Regulatory Cell Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the performance and planned expansion of the Company's contract development and manufacturing business. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 13, 2014, the Company's Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
CONTACT: Investor Contact:
LifeSci Advisors, LLC
Michael Rice
Founding Partner
Phone: +1-646-597-6979
Email: mrice@lifesciadvisors.com
Media Contact:
NeoStem, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@neostem.com
Recent LSTA News
- Lisata Therapeutics Announces First Patient Treated in the Second-line Cholangiocarcinoma Cohort of the BOLSTER Trial • GlobeNewswire Inc. • 09/17/2024 12:00:00 PM
- Lisata Therapeutics to Participate in Upcoming September 2024 Industry and Investor Events • GlobeNewswire Inc. • 09/09/2024 12:00:00 PM
- Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma • GlobeNewswire Inc. • 09/05/2024 12:00:00 PM
- Lisata Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/12/2024 08:05:00 PM
- Lisata Therapeutics to Report Second Quarter 2024 Financial Results and Provide a Business Update on Monday, August 12, 2024 • GlobeNewswire Inc. • 08/05/2024 12:00:00 PM
- Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD™ Technology to Evaluate Efficacy of Pancreatic Cancer Therapy • GlobeNewswire Inc. • 07/18/2024 12:00:00 PM
- Lisata Therapeutics Announces Completion of Enrollment in its Phase 2a BOLSTER Trial of Certepetide in First-Line Cholangiocarcinoma • GlobeNewswire Inc. • 07/16/2024 12:00:00 PM
- Lisata Therapeutics’ Certepetide Shows Promise in Improving Standard Treatment for Intrahepatic Cholangiocarcinoma in a Preclinical Model • GlobeNewswire Inc. • 07/10/2024 12:00:00 PM
- Lisata Therapeutics Announces Full Enrollment of Pancreatic Cancer Cohort of CENDIFOX Trial • GlobeNewswire Inc. • 06/13/2024 12:30:00 PM
- Lisata Therapeutics to Participate in Upcoming June 2024 Industry and Investor Events • GlobeNewswire Inc. • 05/28/2024 12:30:00 PM
- Lisata Therapeutics Receives Paediatric Investigation Plan Waiver from the European Medicines Agency for Certepetide in Pancreatic Cancer • GlobeNewswire Inc. • 05/20/2024 12:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/10/2024 04:15:16 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:13:47 PM
- Lisata Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 08:05:00 PM
- Lisata Therapeutics to Participate in Upcoming May 2024 Industry and Investor Events • GlobeNewswire Inc. • 05/08/2024 12:00:00 PM
- Lisata Therapeutics to Report First Quarter 2024 Financial Results and Provide a Business Update on Thursday, May 9, 2024 • GlobeNewswire Inc. • 05/02/2024 12:00:00 PM
- Lisata Therapeutics and Qilu Pharmaceutical Announce First Patient Treated in Qilu’s Phase 2 Trial in China of LSTA1 in Patients with Metastatic Pancreatic Ductal Adenocarcinoma • GlobeNewswire Inc. • 04/23/2024 11:30:00 AM
- Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma • GlobeNewswire Inc. • 04/09/2024 12:30:00 PM
- Lisata Therapeutics to Participate in Upcoming April 2024 Industry and Investor Events • GlobeNewswire Inc. • 04/03/2024 12:30:00 PM
- Lisata Therapeutics Announces U.S. FDA Rare Pediatric Disease Designation Granted to LSTA1 for the Treatment of Osteosarcoma • GlobeNewswire Inc. • 03/21/2024 12:00:00 PM
- Lisata Therapeutics to Present at the Life Science Investor Forum on March 7ᵗʰ • GlobeNewswire Inc. • 03/04/2024 01:00:00 PM
- Lisata Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 09:05:00 PM
- Lisata Therapeutics to Host Year-End 2023 Conference Call on Thursday, February 29, 2024 at 4:30 p.m. Eastern Time • GlobeNewswire Inc. • 02/22/2024 01:00:00 PM
- Lisata Therapeutics to Present at BIO CEO & Investor Conference • GlobeNewswire Inc. • 02/20/2024 01:00:00 PM
- Lisata Therapeutics to Present at the Sequire Investor Summit in Puerto Rico • GlobeNewswire Inc. • 01/18/2024 01:30:00 PM
Lingerie Fighting Championships Signs Broadcast Deal With Maybacks Global Entertainment • BOTY • Sep 26, 2024 9:00 AM
Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM