Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, announced that combined safety data from the Company’s GALE-401 clinical trials were presented at the European Hematology Association 21st Congress. GALE-401 is Galena’s controlled release (CR) version of anagrelide for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce elevated platelet counts in patients suffering from myeloproliferative neoplasms (MPNs).
A total of six trials have been run with GALE-401, five Phase 1 trials in healthy volunteers (N=98), and one Phase 2 single arm, open label pilot study in MPN patients (N=18). The poster, entitled, “Anagrelide Controlled Release (GALE-401) Safety Profile Consistently Well Tolerated in Myeloproliferative Neoplasms Patients and Healthy Volunteers” was designed to characterize the safety profile of GALE-401 in all subjects treated to date. The results demonstrated that GALE-401 is well tolerated in MPN patients as well as in healthy volunteers. In the Phase 2 study, fewer moderate to severe (Grade 3/4) adverse events (AEs) and fewer AEs per patient (2.3 vs. 3.3) were observed with GALE-401 compared to what has been reported previously with the immediate release (IR) formulation.1 Additionally, for a small subset of subjects treated in the Phase 2 study who were intolerant to anagrelide IR (n=5), GALE-401 appears to offer a longer duration on therapy compared to previous administration of anagrelide IR. Therefore, a randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide naïve subjects, alternatively or together with a trial evaluating anagrelide IR intolerant subjects is warranted.
“The clinical and pharmacokinetic profile of GALE-401 has shown that by reducing the maximum plasma concentration (Cmax) of anagrelide with our controlled release version, GALE-401 seems to confer an improved overall safety profile and potentially offers an improved tolerability compared to the approved product,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Overall, in our Phase 2 study, we observed predominantly mild to moderate toxicities that did not reveal any unexpected AEs, and we are encouraged by the results as it relates to patients who were previously intolerant to anagrelide IR who were able to continue their treatment with GALE-401 for a meaningful longer duration. Given this data, we plan to meet with the FDA later this year to discuss the next stages of development for the asset.”
In the healthy volunteer studies, single and multiple doses of GALE-401 were safe and well tolerated and there were no clinically relevant changes in vital signs, electrocardiograms, and safety laboratory parameters other than a reduction in platelet counts. The most frequent treatment emergent adverse events reported included headache, pain in extremities or back, palpitations and gastrointestinal disturbances. In the Phase 2 MPN trial, patients treated with GALE-401 exhibited fewer of the more common adverse events associated with anagrelide IR (cardiac; general; gastrointestinal; respiratory, thoracic, and mediastinal; skin and subcutaneous tissue; nervous system). Some of the less common AEs of anagrelide IR were comparatively more frequent for GALE-401 (vascular; hepatobiliary; blood and lymphatic). (Original Source)
Shares of Galena Biopharma closed last Friday at $2.08, up $0.10 or 5.05%. GALE has a 1-year high of $2.29 and a 1-year low of $0.59. The stock’s 50-day moving average is $1.58 and its 200-day moving average is $1.24.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on June 7, Maxim Group analyst Jason McCarthy reiterated a Buy rating on GALE, with a price target of $4, which represents a potential upside of 92.3% from where the stock is currently trading. Separately, on June 3, FBR’s Vernon Bernardino reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Vernon Bernardino have a total average return of 3.7% and -13.6% respectively. McCarthy has a success rate of 43.4% and is ranked #892 out of 3892 analysts, while Bernardino has a success rate of 32.2% and is ranked #3859.