The terms of the joint agreement call for Genentech andGalena to sponsor a randomized, blinded, multicenter Phase II clinical study inadjuvant breast cancer to approximately 300 patients within the first sixmonths of 2012.
Earlier clinical studies presented by Galena Biopharma atthe American Society of Clinical Oncology meeting in June 2011 demonstratedpromising results of NeuVax in combination with Herceptin, thus giving hope tobreast 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 thevalidation of NeuVax by a leading biopharmaceutical company, continues to buildvalue for patients and shareholders.
Participants in the study will be both military andcivilian, with the study being conducted at 20 sites worldwide."
Since only 25 percent of patients are HER2-positive andeligible for Herceptin, "the remaining patients who are in remission afterstandard therapy (e.g., surgery,radiation, chemotherapy) are sent home to watch, wait and worry," Ahn tells ddn. "The larger population of patientsnot eligible for Herceptin—HER1- and 2-positive or low to intermediate—areeligible for NeuVax."
Furthermore, NeuVax "has shown promising results both aloneas a monotherapy and in combination with Herceptin," says Ahn. "In a Phase IItrial of 187 patients, 0 percent of the patients who received a full course ofNeuVax treatment (one dose per month for six months and one dose every sixmonths) had a recurrence, versus 23 percent of control patients."
In a combination study, none of the patients who receivedNeuVax and Herceptin had a recurrence, versus 11 percent who relapsed aftergetting 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 IItrial. During Poster Session 1, Galena delivered a presentation titled,"Long-term clinical benefit of adjuvant breast cancer vaccine: Five-yearefficacy of E75 with multiple booster inoculations." The results of the currentlong-term median follow-up at 60 months showed that the NeuVax (E75 plusGM-CSF) breast cancer vaccine is safe and well tolerated, and demonstratesefficacy in preventing breast cancer recurrence in optimally dosed and boostedpatients.
Of the 187 patients enrolled in the study, there were 108 inthe vaccine group and 79 in the control group, according to Ahn. Of the 53patients who received at least one booster inoculation, a statisticallysignificant disease-free survival rate of 95.9 percent was seen versus 79.7percent in the control group.
Several patients remain on study, and Galena estimatesreporting final results of the five-year follow-up in the second half of 2012.For the combined intention-to-treat population, including those patients notgetting boosters as well as those patients suboptimally dosed, a strong trendto prevention of recurrence was still observed, with the vaccine-treatedpatients demonstrating a disease-free survival rate of 89.4 percent versus the79.7 percent in the control group.
"Five years of data is a significant milestone, and NeuVaxcontinues to show a decrease in recurrences for these women with breast cancerwho would otherwise have no treatment options to maintain their disease-freestate," says Dr. Rosemary Mazanet, chief medical officer of Galena.
A major goal for Galena is to establish a development partnerin 2012, Ahn says.
"We believe that NeuVax as an adjuvant treatment forlow-to-intermediate HER2-positive breast cancer represents a blockbusteropportunity," Ahn says. "The Herceptin adjuvant treatment in the 25 percent ofeligible patients alone registered about $2.4 billion in 2010 revenues—whileNeuVax targets a patient population over twice the size."