So far, it has been a banner year for Galena Biopharma Inc. (GALE: Quote) with its shares up more than 236% year-to-date, trading around $1.50. Previously known as RXi Pharmaceuticals Corp., the company took on the name Galena Biopharma Inc. last September, following its separation into two. While Galena now focuses on cancer therapies, the spin-off from Galena - the new RXi Pharmaceuticals Corp. (RXII), continues to develop RNAi-based therapies.
For readers who are new to Galena, here's a brief overview of its pipeline...
Galena's lead product candidate is NeuVax, which came into its fold when the company acquired Apthera Inc. in April 2011. NeuVaX is a synthetic E75 peptide vaccine candidate to prevent recurrence of breast cancer.
Earlier this month, Galena announced the results of combined phase 1/2 Neuvax clinical trials namely, SN-33 (node positive, NP) and SN-34 (node negative, NN), which continue to demonstrate an excellent safety and efficacy profile at median 60-month follow-up.
Initially, patients in the trials were administered monthly injection of NeuVaX for six months. During the course of the trials, a decline in immunity was observed after the initial monthly Primary Vaccine Series, leading to late recurrences of cancer in some patients. In order to maintain long-term immunity following the initial monthly dosing, a voluntary booster program was added to the trials, providing an additional inoculation every six months with a maximum of six boosters.
According to the trial results, at a median of 60-months, the disease-free survival for the booster group was 96.2% vs 80.5% in the control group, and the recurrence rate for the booster group was 3.8% vs 18.9% in the control group. At the time of announcement of the results, there were 53 patients who had received at least one booster.
The final patients are expected to complete their booster treatments and final follow-up visits by September 2012. The final data analysis is expected to be reported in the fourth quarter of this year.
In January of 2012, Galena initiated a phase III trial of NeuVax, dubbed the PRESENT study, under the FDA-approved Special Protocol Assessment. The target patient population for the PRESENT trial is based on the SN-33 trial, namely node-positive breast cancer patients.
Node-positive breast cancer means the breast cancer cells have moved from the original tumor into the lymph nodes under the arm on the side of the breast cancer. This type of cancer is more likely to return or recur after primary therapy.
The PRESENT study is designed to enroll approximately 700 breast cancer patients who are not eligible to receive Roche's Herceptin therapy and who achieve remission with current standard of care. Patients are administered one intradermal injection every month for six months, followed by a booster injection once every six months. The primary endpoint is disease-free survival at three years or 139 events (recurrence of cancer). The study is currently recruiting participants and the estimated primary completion date is May 2015. (final data collection date for primary outcome measure).
The company has also planned a phase II trial of NeuVax in combination with Herceptin for breast cancer.
Also in the pipeline of Galena is Folate Binding Peptide vaccine, E39, which is in an ongoing phase 1/2 trial in ovarian cancer and endometrial adenocarcinomas. A new phase 1b trial studying the benefit of FBP peptide variants in combination with E39 designed by the company is awaiting Institutional Review Board approval.
A quick look at the company's balance sheet...
Being a development-stage company, Galena has not generated any revenue since inception in January, 2003. Net loss for the three months ended March 31, 2012 widened to $24.8 million or $0.52 per share from $3.8 million or $0.19 per share in the year-ago quarter.
As of April 30, 2012, the company had $24.9 million in cash, including net proceeds from the public offering of common stock that was completed on April 16, 2012, to advance its late-stage cancer immunotherapy pipeline.
GALE has thus far hit a 52-week low of $0.36 and a 52-week high of $3.54. The stock closed Tuesday's trading at $1.58, up 22%.
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by RTT Staff Writer
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