Company Update (NASDAQ:GALE): Galena Biopharma Inc Announces the Phase 2 Clinical Trial of NeuVax in Ductal Carcinoma in Situ (DCIS) Open for Enrollment and Screening Patients


Galena Biopharma Inc (NASDAQ:GALE) announced that the NeuVax (nelipepimut-S) Phase 2 clinical trial entitled “VADIS: Phase 2 trial of the Nelipepimut-S Peptide Vaccine in Women with DCIS of the Breast” is now open for enrollment and screening patients. The trial is being run in collaboration with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center Phase I and II Chemoprevention Consortium.

Ductal Carcinoma in Situ (DCIS) is a noninvasive cancer in which abnormal cells are found in the lining of the breast duct and have not spread outside the milk duct to invade other parts of the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently it is extremely challenging to identify which lesions may convert to invasive cancer.  DCIS is the most common type of breast cancer and the rate at which DCIS is diagnosed has increased dramatically in recent years as a result of increased cancer screening.

“The Phase 2 VADIS trial will broaden the development footprint for NeuVax into this new indication as we assess its safety and immunologic efficacy in patients with DCIS,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  “The challenge with DCIS is that the exact course of the disease cannot be determined and consequently the outcomes for patients may be undefined. This study will evaluate NeuVax in its capacity to generate the immune response, including tumor-infiltrating lymphocytes (TILs), that could potentially prevent the progression of the disease. Positive study results from the VADIS trial could provide potential evidence for NeuVax as a first of its kind treatment for the primary prevention of invasive breast cancer, thereby sparing significant numbers of women from disfiguring surgery and radiation treatments.  We are grateful to be working on this innovative initiative with the NCI and the MD Anderson Cancer Center, two of the finest oncology institutions in the country.”

Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the VADIS trial, added, “We are pleased to collaborate with the NCI and Galena on the development of NeuVax in DCIS which affects more than 60,000 women a year. In breast cancer, DCIS may be a precursor to invasive disease, and it is possible that vaccination before tumor cells become genetically unstable and begin dividing rapidly could prevent evolution to malignancy. NeuVax is currently the most advanced breast cancer vaccine in the clinic and we think its broad immune response not only to the specific antigen targeted by the drug, but also to other antigens, speaks to why NeuVax could be an ideal therapeutic candidate in this indication. By vaccinating patients in early-phase disease, we may be giving them long-lasting immunity to protect them down the line.”

The MD Anderson Consortium is funded through the Division of Cancer Prevention at the NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as some financial and administrative support. (Original Source)

Shares of Galena Biopharma closed yesterday at $2.10, up $0.01 or +0.48%. GALE has a 1-year high of $49.80 and a 1-year low of $1.84. The stock’s 50-day moving average is $1.93 and its 200-day moving average is $1.04.

On the ratings front, Galena Biopharma has been the subject of a number of recent research reports. In a report issued on December 2, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $11, which represents a potential upside of 424% from where the stock is currently trading. Separately, on November 10, Maxim Group’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $1.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Jason McCarthy have a yearly average loss of -25.4% and -19.8% respectively. Bernardino has a success rate of 18% and is ranked #4210 out of 4285 analysts, while McCarthy has a success rate of 22% and is ranked #4203.

Galena Biopharma, Inc. engages as a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. It focuses on identifying and advancing therapeutic opportunities to improve cancer care from direct treatment of the disease to the reduction of its debilitating side effects. Its products include Abstral (fentanyl) sublingual tablets and Zuplenz (ondansetron) oral soluble film.