InvestorsHub Logo
Followers 139
Posts 5289
Boards Moderated 0
Alias Born 03/01/2013

Re: None

Thursday, 12/11/2014 9:24:13 AM

Thursday, December 11, 2014 9:24:13 AM

Post# of 10489
Trending up PM news just out on clinical trial progress:
Watch for Frog-Eyed Frogstein Cramer's puppet hatchett-man,
to pop up soon as price starts to rise, why aren't they indicted yet for manipulation?

Overview : Article

Galena Biopharma Presents HER2 Screening Data Including Preliminary Leica Bond Oracle(TM) Results From the Phase 3 NeuVax(TM) (nelipepimut-S) Clinical Trial at the 2014 San Antonio Breast Cancer Symposium (SABCS)
17 minutes ago - DJNF
Galena Biopharma Presents HER2 Screening Data Including Preliminary Leica Bond Oracle(TM) Results From the Phase 3 NeuVax(TM) (nelipepimut-S) Clinical Trial at the 2014 San Antonio Breast Cancer Symposium (SABCS)

PORTLAND, Ore., Dec. 11, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that initial immunohistochemistry (IHC) screening data from the NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial was presented at the 2014 San Antonio Breast Cancer Symposium (SABCS).

The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry (IHC) System for Low and Intermediate Levels (1+, 2+) of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+.

As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle(TM) HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.

Mark W. Schwartz, Ph.D., President & CEO of Galena, commented, "NeuVax is a highly specific, directed immunotherapy targeting the HER2 1+/2+ adjuvant breast cancer patient population where there are no HER2 directed treatment options. Currently approved HER2 agents only target HER2 overexpressing (IHC 3+) breast cancers. As a result, the companion diagnostic tests are only approved to assess IHC 3+ expression of HER2, and there are currently no companion IHC diagnostic tests approved to distinguish between patients who are HER2 IHC 0, 1+, or 2+."

Dr. Schwartz continued, "Given these factors, there is a need to establish a companion diagnostic to show an accurate distinction across all levels of HER2. We are working closely with our partners at Leica utilizing central testing confirmation of the patient samples to ensure that we are enrolling and treating the right patient population in the PRESENT trial, with the hope of offering personalized medicine for these women to prevent their breast cancer recurrence."

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.