NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (CLDX) announced positive results from a Phase 1 multi-dose study of CDX-301 (FMS-like tyrosine kinase-3 ligand) demonstrating that CDX-301 was well-tolerated and can safely and effectively mobilize hematopoietic cell populations in healthy volunteers. The data support future development of CDX-301 in a number of indications, including hematopoietic stem cell transplant and cancer immunotherapy. Results were presented in a poster entitled A Phase 1 Trial of the Hematopoietic Growth Factor CDX-301 (rhuFlt3L) in Healthy Volunteers on Monday, December 10, 2012 at 6:00 pm ET at the American Society of Hematology 54th Annual Meeting and Exposition. The lead author was Niroshana Anandasabapathy, MD, PhD, Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY. The data presented today confirm previous studies and support continued development of CDX-301, both alone and in combination with other Celldex assets across a broad range of indications, said Thomas Davis, MD, Senior Vice President and Chief Medical Officer. In particular, we believe CDX-301 holds significant potential for use in hematopoietic stem cell transplant, where it has demonstrated improvement of blood cell reconstitution in preclinical in vivo models. Data from the Phase 1 study will enable us to define an … Continue reading →

NEW YORK & PETACH TIKVA, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, is proud to announce that its positive Phase I/II ALS clinical trial data was selected as the opening presentation of the prestigious Israel Neurological Associations Annual Meeting, which will convene on December 12, 2012 in Jerusalem, Israel. The data, regarding the first 12 ALS patients in the trial, will be presented by Principal Investigator Dr. Dimitrios Karussis, MD, of the Neurology Department at Hadassah Medical Center in Jerusalem, Israel. The trial, which was designed to evaluate the safety and tolerability of BrainStorm's proprietary NurOwn cell therapy (bone marrow-derived, autologous, differentiated mesenchymal stromal cells) is being conducted at the Hadassah Medical Center in Jerusalem, Israel. The data being presented is on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig's disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally. NurOwn was granted Orphan Drug designation for ALS by the US Food and Drug Administration (FDA). BrainStorm is planning to expand its ALS clinical development to the United States in 2013, pending FDA approval. The Company … Continue reading →

ATLANTA--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in the treatment of CTCL. Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression (Abstract #797) The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include: Results of a Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #3688) Data … Continue reading →