BioLineRx’s Stem Cell Mobilization Therapy BL-8040 to Enter Phase 3 Trial

BioLineRx’s Stem Cell Mobilization Therapy BL-8040 to Enter Phase 3 Trial
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BioLineRx’s stem cell mobilization drug, BL-8040, to enter Phase 3 trials

BioLineRx is seeking regulatory approval to advance into a Phase 3 clinical trial its treatment BL-8040, for blood stem cell mobilization to prepare for autologous transplants in patients with multiple myeloma.

The company hopes that the trial, called GENESIS, will allow BL-8040 to become an approved treatment for myeloma. The study is expected to launch before the end of the year.

“We are excited to move forward with BL-8040 into a Phase 3 registration study,” Philip Serlin, BioLineRx chief executive officer, said in a press release.

“We have previously reported positive results supporting BL-8040 as a one-day dosing and up-to-two-day collection regimen for rapid mobilization of stem cells. This represents a significant improvement over the current treatment, which requires four-to-eight daily injections of G-CSF and one to-four apheresis sessions. We therefore hope that this Phase 3 trial will further support these results and help improve the standard of care for multiple myeloma patients,” he added.

Stem cell mobilization is a procedure used to gather stem cells from a donor or from affected patients. These cells, normally produced in the bone marrow, are forced to enter circulation with the help of a compound called G-CSF (granulocyte colony-stimulating factor). They are then gathered from the blood using a process called apheresis, allowing easier access compared to a spinal tap procedure.

But using G-CSF is a slow procedure linked to side effects such as bone pain.

The Phase 3 trial will explore if BL-8040 used with G-CSF can safely improve the treatment. The study will be conducted in two parts. First, researchers will determine the optimal dosing of BL-8040 in up to 30 patients.

Next, 180 patients will be randomized to receive BL-8040 or a placebo. Researchers will assess the ability of the treatment to mobilize enough stem cells after one administration of BL-8040 and G-CSF, with a maximum of two apheresis sessions.

Patients receiving the combination will be compared to those receiving a placebo and G-CSF.

A Phase 2 trial of the approach is currently ongoing, and interim results showed that a single injection of the combination mobilized stem cells to a similar extent as four to six injections of G-CSF alone, currently the standard approach. The company reported no safety issues at the time.

BL-8040 is a compound that has more use as a cancer treatment than as a stem cell mobilizing agent. The therapy acts to block a receptor called CXCR4, found in higher-than-normal levels in 70% of human cancers.

Studies show that by blocking CXCR4 with BL-8040, cancer cells also are forced to leave the bone marrow. In circulation, they are then sensitized to chemotherapy or biological cancer therapies. BL-8040 also directly kills cancer cells by turning on cellular self-destruction mechanisms.

“In parallel, we are continuing to expand the potential of our robust BL-8040 oncology platform, by advancing multiple clinical studies for additional indications that are ongoing or expected to commence during 2017,” Serlin said.

“These include a large, randomized, controlled Phase 2b study in AML, as well as several Phase 2 combination studies with immune checkpoint inhibitors in solid tumors and hematological malignancies,” he added.

The post BioLineRx’s Stem Cell Mobilization Therapy BL-8040 to Enter Phase 3 Trial appeared first on Myeloma Research News.

Magdalena holds an MSc in Pharmaceutical Bioscience and an interdisciplinary PhD merging the fields of psychiatry, immunology and neuropharmacology. Her previous research focused on metabolic and immunologic changes in psychotic disorders. She is now focusing on science writing, allowing her to culture her passion for medical science and human health.