- GALE-401 was well tolerated with primarily Grade 1 and 2 toxicities
- Phase 2 pilot study demonstrated an Overall Response Rate of 78%
PORTLAND, Ore., June 15, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 2 clinical trial of GALE-401 was presented at the European Hematology Association 20th Congress in Vienna, Austria. The GALE-401 Phase 2 pilot study is a single arm, open label, multi-center study evaluating the efficacy and safety of anagrelide controlled release in subjects with thrombocytosis secondary to essential thrombocythemia (ET) and other myeloproliferative neoplasms (MPNs).
The poster presentation, entitled, "Phase 2 Study of a Novel Controlled-Release Formulation of Anagrelide (GALE-401) in Subjects with Myeloproliferative Neoplasm (MPN)-Related Thrombocytosis," was presented on Saturday, June 13, 2015. The Phase 2 study demonstrated that GALE-401 was well tolerated with primarily Grade 1 and 2 toxicities in 16 of the 18 subjects enrolled. The efficacy shown in the trial compares favorably to historical anagrelide immediate release (IR) response rates with the following platelet response: overall response rate (ORR) of 78% (14/18); complete response (CR) of 39% (7/18); partial response (PR) of 39% (7/18). The median time to response was 5 weeks (range, 3–10), and the median duration of response has not yet been reached. Based on the data, the investigators concluded that GALE-401 remains a viable potential treatment option for MPNs, and a randomized trial comparing GALE-401 versus anagrelide IR is warranted. Final data from the GALE-401 Phase 2 trial is expected to be presented at the American Society of Hematology conference in December.
"We are encouraged by this initial trial in MPN patients showing GALE-401 is well tolerated with an overall response rate of 78%," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "We expect to report more mature data on the trial this Fall, and are evaluating potential next steps to further advance GALE-401 in the clinic. We are grateful to the patients who volunteered for this trial and for the site staff and investigators who continue to work with us to treat these patients and advance the asset."
"Myeloproliferative neoplasms are progressive blood cancers that can strike anyone at any age, and is a condition patients live with for the rest of their lives. This first-in-patient data from anagrelide controlled release is promising as a potential treatment option for these patients and warrants an additional trial to further assess the characteristics of the agent and its potential," added Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and principal investigator for the Phase 2 trial.
The primary objective of the study was to estimate ORR with the secondary objectives of safety, tolerability and pharmacokinetics (PK). Enrolled patients were adult men and women diagnosed with an MPN-related elevated platelet count to include chronic myelogenous leukemia (CML), polycythemia vera (PV), primary myelofibrosis (PMF), or ET. Patient eligibility requirements also included:
- Platelet count ≥ 600 K/μL on two occasions at least 14 days apart prior to first dose of study drug
- MPN diagnosis other than ET, concurrent anti-MPN treatment was permitted, provided that the doses are stable at least 4 weeks prior to first dose of study drug
- Currently not receiving therapy specifically intended to reduce platelet counts
- Adequate hepatic function
GALE-401 was administered at a starting dose of 0.5 mg twice daily (1.0 mg/day). The dose was titrated at weekly intervals, on an individual basis, to determine the lowest dose required to achieve and maintain a target platelet count of 150–400 K/μL. Platelet response is defined as complete response (CR, ≤ 400 K/μL) or partial response (PR, ≤ 600 K/μL or ≥ 50% reduction from baseline) maintained for at least 4 weeks.
About GALE-401 (Anagrelide Controlled Release)
GALE-401 (Anagrelide Controlled Release) contains the active ingredient anagrelide. The currently available immediate release formulation (Agrylin® or anagrelide IR) is approved by the FDA for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Adverse events associated with anagrelide IR, such as nausea, diarrhea, abdominal pain, palpitations, tachycardia, and headache, may be dose and plasma concentration dependent. Reducing the maximum plasma concentration (Cmax) is expected to reduce side effects, but preserve efficacy. GALE-401 is a reformulated, controlled release version of anagrelide. A Phase 2 pilot study with GALE-401 is ongoing. Preliminary data has demonstrated that the agent is well tolerated with primarily Grade 1 and 2 toxicities. The efficacy shown in the trial compares favorably to historical anagrelide IR response rates with an overall response rate (ORR) of 78% (n=14/18). Final data from the GALE-401 Phase 2 trial is expected to be presented at the American Society of Hematology conference in December.
About Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a closely related group of hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally. The main MPNs are polycythemia vera (PV), chronic myelogenous leukemia (CML), primary myelofibrosis (PMF), essential thrombocythemia (ET), and all of which are associated with high platelet counts. The MPNs are progressive blood cancers that can strike anyone at any age, and for which there is no known cure.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy 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. For more information, visit www.galenabiopharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena's product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
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