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BL-8040 clears Phase 2 safety trial
May 2016
by Lori Lesko  |  Email the author
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TEL AVIV, Israel—Aimed at developing an effective treatment—and eventual cure—for relapsed or refractory acute myeloid leukemia (r/r AML), a cancer of the blood and bone marrow, clinical-stage biopharmaceutical BioLineRx has reported successful positive top-line results following the Phase 2 clinical trial of the drug BL-8040. Detailed results will be presented at an upcoming scientific conference.
 
Approximately 19,000 new cases of AML were diagnosed in the United States in 2014, with the median age of onset at 67, according to the American Cancer Society. The first treatment line for patients with AML includes a combination of chemotherapy drugs, rendering patients weak and sick and significantly impacting their quality of life. Scientists discovered that patients’ median outcome after chemo was less than two years.
 
However, the addition of BL-8040 to the treatment resulted in another story.
 
The Phase 2 trial was a multicenter, open-label study designed to assess the safety, efficacy pharmacodynamics and pharmacokinetic parameters of BL-8040, in combination with Cytarabine (Ara-C) for the treatment of adult r/r AML patients. Forty-two patients with r/r AML were enrolled in the study, which included a dose-escalation stage followed by an expansion stage. Each patient received a once-daily dose of BL-8040 monotherapy on days one and two, followed by the same dose of BL-8040 plus Ara-C on days three to seven. Clinical response to treatment was evaluated by bone marrow biopsy on day 30. Results indicated that BL-8040, as a single agent and in combination with Ara-C, was safe and well tolerated at all doses tested, up to and including the highest dose level of 2 mg/kg, with no major adverse events.
 
“We are very enthusiastic about the positive results from the Phase 2 trial with BL-8040 for the treatment of relapsed or refractory AML,” Dr. Kinneret Savitsky, CEO of BioLineRx, stated in a press release. “We are especially excited that for the first time, we see a direct correlation between clinical response and a specific subset of the study patient population. Given that AML is a heterogeneous disease, the ability to pre-define the population that may benefit from CXCR4 inhibition is very important for future development.”
 
“The majority of high-risk AML patients achieved first complete remission relapse within one year, despite the current standard consolidation therapy,” Savitsky added. “Patients with AML relapse have a poor prognosis despite further therapy, and less than 10 percent of these patients are cured by conventional therapy.”
 
The results showed that BL-8040 “not only significantly induces mobilization of leukemic cells from the protective microenvironment of the bone marrow into the peripheral blood, but also directly leads to apoptosis of leukemic progenitor cells and triggers terminal differentiation of the cells into granulocytes,” he said.
 
Leukemic stem cells that are “dormant in the bone marrow are presumed to be a major reason for AML relapse,” Savitsky noted. “Based on the preclinical and clinical data accumulated to date, BL-8040 is anticipated to boost the efficacy of consolidation therapy due to its dual mechanism of action,” which first “induces mobilization of leukemic cells from the bone marrow, which enhances the cytotoxic effects of chemotherapy, and secondly, it possesses anti-leukemic pro-apoptotic properties that help eliminate AML cells directly.”
 
“Combined with the impressive remission rate reported from subjects receiving BL-8040 doses of 1 mg/kg or higher, the results strongly suggest that BL-8040 has potent anti-leukemic activity and, in combination with Cytarabine, may improve the response typically achieved in this advanced AML population,” he remarked. “These successful results also reinforce our excitement about BL-8040’s overall potential in the AML space, including as an AML consolidation treatment that is currently being investigated in a large Phase 2b study at approximately 25 sites in Germany. Given these positive results, we now plan to meet with the regulatory authorities to discuss the next steps in the development of this promising program.”
 
Dr. Arnon Aharon, vice president of Medical Affairs at BioLineRx, told DDNews, “With regard to the durability of the response to treatment, we are following our patients for overall survival (OS) and will publish that data once we complete the patients’ followup. We plan to continue development of BL-8040 for the treatment of AML, with an emphasis on the consolidation treatment line for which we are currently conducting a Phase 2b trial. In addition, we recently entered into an immuno-oncology collaboration with Merck under which we plan to initiate a Phase 2 clinical study to investigate BL-8040 in combination with Keytruda for the treatment of pancreative cancer.”
 
On March 23, BioLineRx announced the initiation of a Phase 2 trial for BL-8040 as a novel approach for the mobilization and collection of bone marrow stem cells from peripheral blood circulation. The study will be conducted in collaboration with the Washington University School of Medicine Division of Oncology and Hematology, and is designed to evaluate the ability of BL-8040 as a single agent to promote stem cell mobilization for allogeneic transplantation.
 
Code: E051617

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