Efficacy And Safety Study Of NeuVax(TM)(Nelipepimut-S Or E75 ...
Efficacy and Safety Study of NeuVax(TM)(Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT) Purpose Purpose of this trial: 1. To assess the efficacy and safety of Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after ... Content Retrieval
FDA Special Protocol Assessment - Wikipedia, The Free ...
A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. ... Read Article
Galena Biopharma Reports Second Quarter 2015 Financial Results
August 6, 2015 Galena Biopharma Reports Second Quarter 2015 Financial Results Completed over -enrollment in the NeuVax Phase 3 PRESENT breast cancer immunotherapy clinical trial and ... Get Document
Galena Biopharma Announces Department Of Defense Grant For ...
April 28, 2014 Galena Biopharma Announces Department of Defense Grant for NeuVax(TM) (nelipepimut - S) Clinical Trial Phase 2 study in neoadjuvant, HER2 3+ Breast Cancer Patients to commence in 2014 ... View Document
U.S. Food And Drug Administration
U.S. Food and Drug Administration. Notice: but is no longer maintained and may be outdated. Clinical Trial Endpoints Eugene J. Sullivan, MD FCCP. Chief Medical Officer. – “substantial evidence” – “adequate and well-controlled” trials • trial designs, types of controls ... Read Here
Small-Cap Research
Clinical trial of NeuVax at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer. ... Get Document
Breast Cancer Vaccine Research Study - NeuVax™
Breast Cancer Vaccine Research Study Lymph Node-Positive Early Stage Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax™Treatment “PRESENT”: NeuVax TM For more information: enrolling clinical trial sites. ... View This Document
Small-Cap Research
Clinical trial of NeuVax at the American Society of Clinical Oncology (ASCO) RXis principal activities consisted of conducting discovery research and pre-clinical development activities utilizing its RNAi therapeutic platform, acquiring RNAi ... Retrieve Document
Department Of Defense Grant For NeuVax™ (nelipepimut-S ...
11 Department of Defense Grant for NeuVax™ (nelipepimut-S) Clinical Trial - We announced the Department of Defense is providing grant funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high ... Get Content Here
Galena Biopharma To Present HER2 Screening Data From The ...
December 5, 2014 Galena Biopharma to Present HER2 Screening Data From the Phase 3 NeuVax(TM) (nelipepimut-S) Clinical Trial at the 2014 San Antonio Breast Cancer Symposium (SABCS) ... View Document
Small-Cap Research - Zacks Investment Research
Zacks Investment Research Page 3 scr.zacks.com IP Further Expanded for NeuVax and Folate Recently, Galena (GALE) presented data from the Phase I/II clinical trial of NeuVax (E75) at some meetings including the ASCO 2012 Annual Meeting. At the ASCO, ... Document Viewer
Galena Biopharma Announces Independent Data Safety Monitoring ...
August 24, 2015 Galena Biopharma Announces Independent Data Safety Monitoring Committee Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax(TM) PRESENT Trial ... View Doc
The HER2 Peptide Nelipepimut-S (E75) Vaccine (NeuVax™) In ...
We briefly discuss our clinical trial experience with NeuVax focusing on immunologic response data and its implication on how the immune system may be affected by this peptide vaccine. Most importantly, we demonstrate the potential capability of certain ... View Doc
Completed SN33 Trial: 60 Month Follow-up Of Early Stage Node ...
Completed SN33 Trial: 60 month Follow-up of Early Stage Node Positive HER2 Negative Patients with NeuVax™ (E75) and Sargramostim Rosemary Mazanet, Mark W. Schwartz, present the final 60-month results of a Phase 1/2 clinical trial ... Content Retrieval
RX I PHARMACEUTICALS CORP (NASDAQCM: RXII)
Phase 3 clinical trial in 2012 to test its efficacy against node-positive breast cancer. RXi Pharmaceuticals Corp. April 5, 2011 TABLE OF CONTENTS NeuVax Clinical Data ... Fetch This Document
JAWS II + GM-CSF - YouTube
How NeuVax™ Works - Duration: 2:42. by Galena Biopharma 24,328 views. 2:42 USMLE Immunology Barbara Benefits from Arthritis Clinical Trial - Duration: 2:34. by Sutter Health Sacramento Sierra Region 95 views. 2:34 JAWS II + CpG - Duration: 0:21. ... View Video
Small-Cap Research
NeuVax, its Phase I/II clinical trial for Folate Binding Protein-E39 (FBP), the planned Phase II clinical trial for NeuVax in combination with trastuzumab (Herceptin®), as well as for general corporate purposes. ... View Document
Galena Biopharma - C.ymcdn.com
Galena Biopharma 4640 SW Macadam, Suite 270 Portland, Oregon 97239 Phase 3 clinical trial. The Company’s commercial drugs include Abstral® - Initiated the Phase 2 NeuVax/Herceptin combination trial in HER2 3+ breast cancer patients ... Retrieve Here
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