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A positive outcome for breast cancer patients
LAKE OSWEGO, Oregon—Aimed at preventing a recurrence of breast cancer in survivors in remission, biotechnology company Galena Biopharma has launched a clinical collaboration with Genentech/Roche and the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) for the development of NeuVax (E75) to be used in combination with Herceptin (trastuzumab from Genentech/Roche).
The terms of the joint agreement call for Genentech and Galena to sponsor a randomized, blinded, multicenter Phase II clinical study in adjuvant breast cancer to approximately 300 patients within the first six months of 2012.
Earlier clinical studies presented by Galena Biopharma at the American Society of Clinical Oncology meeting in June 2011 demonstrated promising results of NeuVax in combination with Herceptin, thus giving hope to breast cancer patients and survivors.
Mark J. Ahn, president and CEO of Galena Biopharma, stated, "The potential to expand on our upcoming Phase III program, as well as the validation of NeuVax by a leading biopharmaceutical company, continues to build value for patients and shareholders.
Participants in the study will be both military and civilian, with the study being conducted at 20 sites worldwide."
Since only 25 percent of patients are HER2-positive and eligible for Herceptin, "the remaining patients who are in remission after standard therapy (e.g., surgery, radiation, chemotherapy) are sent home to watch, wait and worry," Ahn tells ddn. "The larger population of patients not eligible for Herceptin—HER1- and 2-positive or low to intermediate—are eligible for NeuVax."
Furthermore, NeuVax "has shown promising results both alone as a monotherapy and in combination with Herceptin," says Ahn. "In a Phase II trial of 187 patients, 0 percent of the patients who received a full course of NeuVax treatment (one dose per month for six months and one dose every six months) had a recurrence, versus 23 percent of control patients."
In a combination study, none of the patients who received NeuVax and Herceptin had a recurrence, versus 11 percent who relapsed after getting Herceptin alone, he says.
At the 34th annual San Antonio Breast Cancer Symposium Dec. 7, Galena announced five-year efficacy data from the ongoing NeuVax Phase II trial. During Poster Session 1, Galena delivered a presentation titled, "Long-term clinical benefit of adjuvant breast cancer vaccine: Five-year efficacy of E75 with multiple booster inoculations." The results of the current long-term median follow-up at 60 months showed that the NeuVax (E75 plus GM-CSF) breast cancer vaccine is safe and well tolerated, and demonstrates efficacy in preventing breast cancer recurrence in optimally dosed and boosted patients.
Of the 187 patients enrolled in the study, there were 108 in the vaccine group and 79 in the control group, according to Ahn. Of the 53 patients who received at least one booster inoculation, a statistically significant disease-free survival rate of 95.9 percent was seen versus 79.7 percent in the control group.
Several patients remain on study, and Galena estimates reporting final results of the five-year follow-up in the second half of 2012. For the combined intention-to-treat population, including those patients not getting boosters as well as those patients suboptimally dosed, a strong trend to prevention of recurrence was still observed, with the vaccine-treated patients demonstrating a disease-free survival rate of 89.4 percent versus the 79.7 percent in the control group.
"Five years of data is a significant milestone, and NeuVax continues to show a decrease in recurrences for these women with breast cancer who would otherwise have no treatment options to maintain their disease-free state," says Dr. Rosemary Mazanet, chief medical officer of Galena.
A major goal for Galena is to establish a development partner in 2012, Ahn says.
"We believe that NeuVax as an adjuvant treatment for low-to-intermediate HER2-positive breast cancer represents a blockbuster opportunity," Ahn says. "The Herceptin adjuvant treatment in the 25 percent of eligible patients alone registered about $2.4 billion in 2010 revenues—while NeuVax targets a patient population over twice the size."