Galena Biopharma, a
biopharmaceutical company developing oncology treatments to advance cancer
care, today reports that it has enrolled the first patient in the phase 2 trial
for GALE-301, the company’s folate binding protein (FBP) vaccine. GALE-301 will
be administered in combination with granulocyte macrophage-colony stimulating
factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk,
endometrial and ovarian cancer patients that have been rendered disease-free
after completing standard of care therapy.
The phase 2 is an open-label
trial with two arms consisting of HLA-A2 positive patients treated with the FBP
peptide plus adjuvant versus active control. Following the initial induction
series of six vaccinations given once per month, patients will be boosted twice
at six-month intervals.
The primary endpoint of this
phase 2 trial is to measure immune response, with secondary outcomes of
recurrence. The company’s optimism for the outcome of the phase 2 trial is
largely due to positive phase 1 results.
“With GALE-301 progressing
into its phase 2 trial, we continue to demonstrate progress of our innovative
cancer immunotherapy pipeline,” Mark J. Ahn, Ph.D., GALE’s president and CEO,
stated in the news release. “Once recurrent, ovarian and endometrial cancers
are two of the deadliest malignancies, therefore preventing metastatic disease
is critical. We are encouraged by the promising early results of GALE-301 in
addressing this critical unmet medical need.”
The early results referenced
by Dr. Ahn are the initial results from Galena’s phase 1 trial, in which the
optimal dose was determined. Furthermore, data showed that GALE-301 was well-tolerated
and evoked a FBP specific immunological response. After a median follow-up of
six months from completion of the vaccine series, there were two recurrences
(13.3%) in the vaccine group vs. four recurrences (25%) in the control group,
though the company notes that the trial was not powered for any efficacy
measurements.
For more information, visit
www.galenabiopharma.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
