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Galena Biopharma, Inc.

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Nov 18, 2014

Galena Biopharma Completes Enrollment in GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial

Enrollment completed six months ahead of schedule

Phase 1 and early Phase 2 data to be presented at the American Society of Hematology 56th Annual Meeting in December, with top-line data in mid-year 2015
PORTLAND, Ore., Nov. 18, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the completion of enrollment in the GALE-401, or Anagrelide Controlled Release, Phase 2 Clinical Trial. The Phase 2, clinical proof-of-concept study is treating 18 patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), and Primary Myelofibrosis (PMF).

The Phase 2 trial is an open-label, single-arm, multicenter study designed to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure plasma concentrations of anagrelide. The platelet lowering ability of GALE-401 will be measured by the proportion of patients that achieve a complete or partial platelet response for at least four weeks during 24 weeks of treatment. With enrollment complete, patients will now be followed for platelet response while they continue study treatment.

"Completing enrollment approximately six months ahead of schedule in the GALE-401 Phase 2 trial will allow us to present key data in 2015," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "Once we assess the results of this clinical proof-of-concept trial, we will determine the best path forward for the compound. I am proud of the work done by our team, and grateful for our investigators and patients who supported this trial, some of whom switched from their current therapy to participate."

GALE-401 is Galena's new formulation of anagrelide. GALE-401 releases the active ingredient more slowly over time than currently marketed versions of this drug, and is therefore absorbed more slowly into the bloodstream. This slower release of drug could help to reduce adverse events that might be caused by high blood concentrations when the drug is absorbed rapidly, as it is with currently marketed products. Based on discussions with the U.S. Food and Drug Administration (FDA) and pending a successful development program, Galena would pursue approval via the 505(b)(2) regulatory pathway.
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Source: press release, 10/18/14. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=883529

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GALE-401 in Phase 2 Study in Patients With Elevated Platelet Counts in Myeloproliferative Neoplasms (MPNs) Including Essential Thrombocythemia (ET)

PORTLAND, Ore., Sept. 9, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the first patient has been dosed in the GALE-401, or Anagrelide Controlled Release (CR), Phase 2 Clinical Trial. The Phase 2 study will treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET). Based on discussions with the U.S. Food and Drug Administration (FDA) and pending a successful development program, Galena would pursue approval via the 505(b)(2) regulatory pathway.

The Phase 2 trial is an open-label, single-arm, multicenter study of GALE-401 in 20 patients with MPN-related thrombocytosis. The goals of the study are to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure blood levels of the drug. The primary efficacy endpoint will be the proportion of subjects who achieve a complete or partial platelet response for at least four weeks during the first six months of treatment.

"Moving GALE-401 into the clinic is an important advancement in the treatment of MPN diseases, as well as for Galena's overall product pipeline," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The initiation of this Phase 2 trial officially signals Galena's expansion into hematology following our acquisition of the compound earlier this year. With GALE-401, we hope to offer an alternative treatment option for patients suffering from high platelet counts resulting from MPN diseases. I am proud of our clinical development team's effort to advance this program and we look forward to top line data from the study in 2015."

MPNs encompass a family of diseases including essential thrombocythemia, polycythemia vera, primary myelofibrosis, and chronic myelogenous leukemia. The active ingredient immediate release version of anagrelide has been shown to reduce excessive platelet counts and has been approved by the FDA for treating high platelet counts in patients with MPNs. Anagrelide CR is Galena's new formulation of anagrelide that releases the active ingredient more slowly over time than currently marketed versions of this drug, and is therefore absorbed more slowly into the bloodstream. This slower release of drug could help to reduce adverse events that might be caused by high blood concentrations when the drug is absorbed rapidly, as it is with currently marketed products.

"While current treatment options for high platelet counts are effective, they sometimes cause significant side-effects that may prevent patients from taking an adequate dose of their medications. I look forward to working with anagrelide CR to explore this formulation to slowly release the drug into the patient's system and potentially provide better outcomes," 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.
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Source: press release, 9/09/14. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=869793

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A Phase 2, Open Label Efficacy and Safety Study of Anagrelide Controlled Release (CR) in Subjects With Thrombocytosis Secondary to Essential Thrombocythemia and Other Myeloproliferative Neoplasms (MPN)
Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02125318?term=GALE&rank=3

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
GALE-401 (Anagrelide hydrochloride CR)Oncology HematologicEssential thrombocythemiaSynthetic quinazoline derivativeCyclic AMP phosphodiesterase

Mechanism of action: GALE-401 (Anagrelide hydrochloride CR) is a hydrochloride salt of a synthetic quinazoline derivative, anagrelide hydrochloride reduces platelet production through a decrease in megakaryocyte maturation. Anagrelide inhibits cyclic AMP phosphodiesterase, as well as ADP- and collagen-induced platelet aggregation. At therapeutic doses, it does not influence white cell counts or coagulation parameters. Anagrelide is used for treatment of essential thrombocythemia to reduce elevated platelet counts and the risk of thrombosis.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2014-12-06 - 2014-12-09

Results:

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Galena Biopharma Presents Final GALE-401 Phase 2 Clinical Data at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition

SAN RAMON, Calif., Dec. 8, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the final data from the Company's GALE-401 (anagrelide controlled release (CR)) Phase 2 proof-of-concept clinical trial was presented at the 57th American Society of Hematology (ASH) Annual Meeting.

Poster #4074, "Final results of anagrelide controlled-release (GALE-401) safety, efficacy and pharmacokinetics in subjects with myeloproliferative neoplasms (MPN)-related thrombocytosis," presented data on the GALE-401-201, Phase 2, pilot, single arm, open label, multi-center study with eighteen patients enrolled. The study evaluated the safety and efficacy of anagrelide CR in subjects with thrombocytosis secondary to essential thrombocythemia (ET) and other MPNs.

The study demonstrated GALE-401 is well tolerated and the efficacy compares favorably to historical anagrelide immediate release (IR) with reported platelet count best response rates, based on the WHO 2008 criteria, of eleven (61.1%) complete responses (CR), four (22.2%) partial responses (PR), and an overall response rate (ORR) of 83.3%. Platelet response is defined as CR (≤ 400 x 109/L), or PR (≤ 600 x 109/L or ≥ 50% reduction from baseline) maintained for at least 4 weeks. The mean time to response, defined as platelet count ≤ 600 x109/L, ranged from 1 to 9 weeks with GALE-401, which compares favorable to historical anagrelide IR, where time to response ranged from 4 to 12 weeks. Fourteen of 18 subjects enrolled experienced a treatment related adverse event (AE); however, the vast majority of AEs were Grade 1/2 with no patients discontinuing therapy due to progression of disease. Nine patients remain on trial and the median time of response has not yet been reached.

"The data presented demonstrate that GALE-401 remains a viable potential treatment option for patients suffering from MPN disorders, in particular, essential thrombocythemia," said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. "The Phase 2 study enrolled patients with essential thrombocythemia and polycythemia vera including those who had previously been treated with anagrelide. Based on the data, we believe a randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide naïve subjects is warranted. Galena intends to request a meeting with the FDA to determine the best development path to registration based on the results of the study."

The primary objective for the trial was to estimate the overall platelet response rate (ORR) with secondary objectives of safety, tolerability and pharmacokinetics (PK). Eligible patients met the following criteria: male or female ≥ 18 years of age; diagnosed with a MPN related elevated platelet count to include ET, chronic myelogenous leukemia, polycythemia vera, or primary myelofibrosis; platelet count ≥ 600 109/L on two occasions at least 14 days apart prior to first dose of study drug; for patients with MPN diagnosis other than ET, concurrent anti-MPN treatment was permitted, provided that the doses were stable at least four weeks prior to first dose of study drug; and, patients were not receiving therapy specifically intended to reduce platelet counts. GALE-401 was administered at a starting dose of 0.5 mg twice daily (1.0 mg/day) and 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 x 109/L. Toxicities were based on NCI CTCAE v4.03.
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Source: press release, 12/08/15. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=946128

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Galena Biopharma Presents GALE-401 (Anagrelide Controlled Release) Phase 2 Data at the European Hematology Association 20th Congress

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.
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Source: press release, 6/15/15. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=917860

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