Company Update (NASDAQ:GALE): Galena Biopharma Inc Collaborates With the National Cancer Institute on a Phase 2 Clinical Trial With NeuVax in Ductal Carcinoma in Situ Patients


Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced a collaboration with the National Cancer Institute (NCI) to initiate a new, Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in patients diagnosed with Ductal Carcinoma in Situ (DCIS). The trial will be entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women withDCIS of the Breast. The University of Texas M.D. Anderson Cancer Center (MDACC) Phase I and II Chemoprevention Consortium is the lead for this multi-center trial with Elizabeth Mittendorf, MD, PhD serving as the study Principal Investigator. The Consortium is funded through the Division of Cancer Prevention at NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as additional financial and administrative support. The trial is expected to initiate in the fourth quarter of 2015.

“We are pleased to have been chosen by the NCI and M.D. Anderson, two world-renowned institutions, on this groundbreaking study to potentially advance NeuVax earlier in the treatment cycle towards primary prevention of breast cancer,” said Mark W. Schwartz, PhD, President and Chief Executive Officer. “NeuVax generates a significant and potent HER2 directed T-cell response, and this Phase 2 clinical trial will evaluate the CD8+ T cell response generated by NeuVax and whether this induced activation of the immune system suppresses the growth of DCIS cells. We look forward to initiating this trial with our partners before year end.”

The Phase 2 clinical trial will be a single-blind, double arm, randomized, controlled trial comparing NeuVax combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) versus GM-CSF alone. Adult women eligible for the trial will be pre- or post-menopausal with DCIS diagnosed via their core needle biopsy and will be positive for the human leukocyte antigen (HLA) allele A2, or HLA-A2 positive. The trial will enroll a total of 48 patients randomized in a 2:1 ratio, 32 in the active arm and 16 in the control arm. After completion of local therapy to include surgery and when indicated, radiation, the treatment regimen will consist of three doses prior to, and three doses after surgery, for a total of six injections of either vaccine or control, depending on the arm in which the patients are randomized. The primary endpoint for the trial is immunological, evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients compared to patients receiving GM-CSF alone. Secondary endpoints include safety, immune response via epitope spreading, presence of DCIS at resection, and difference in HER2 expression.

The NCI’s Division of Cancer Prevention (DCP) conducts and supports research to determine a person’s risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer. With an overall goal to detect such changes and intervene early in the cancer process to prevent symptomatic disease and death, DCP funds and provides administrative support to clinical and laboratory researchers, community and multidisciplinary teams, and collaborative scientific networks. (Original Source)

Shares of Galena Biopharma closed yesterday at $1.39. GALE has a 1-year high of $2.39 and a 1-year low of $1.10. The stock’s 50-day moving average is $1.59 and its 200-day moving average is $1.58.

On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on September 28, Maxim Group analyst Jason McCarthy reiterated a Buy rating on GALE, with a price target of $7, which represents a potential upside of 403.6% from where the stock is currently trading. Separately, on August 7, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $5.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Vernon Bernardino have a total average return of -19.7% and -23.9% respectively. McCarthy has a success rate of 7.1% and is ranked #3649 out of 3754 analysts, while Bernardino has a success rate of 14.3% and is ranked #3738.

The street is mostly Bullish on GALE stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Sell the stock.

Galena Biopharma Inc, is abiopharmaceutical company focused on developing and commercializing targeted oncology therapeutics that address medical needs across the full spectrum of cancer care.

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