MultiCell Technologies Inc (MCET)

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First Patient Dosed in HA HER2-Negative Breast Cancer Trial

Tuesday, Jul 26, 2016


First Patient Dosed in HA HER2-Negative Breast Cancer Trial
RDR Staff
Published Online: Tuesday, Jul 26, 2016
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The first patient was dosed in a collaborative phase 1b/2 clinical trial between Eisai Inc. and Halozyme Therapeutics to assess whether Esai’s eribulin mesylate (Eribulin) in combination with Haloyzym’s PEGylated recombinant human hyaluronidase (PEGPH20) is beneficial to overall response rate (ORR) in patients diagnosed with High-Hyaluronan (HA) human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

The study is a randomized, Open-label, Multicenter, Phase 1b/2 trial estimating in 96 patients enrolled. The Phase 1b part of the trial will have dose limiting toxicity (DLT) assessed in the first cycle to determine the Recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGPH20. In the Phase 2 part, participants will be stratified by triple negative breast cancer (TNBC) status and randomized to receive eribulin mesylate and PEGPH20 at the established RP2D level or eribulin mesylate alone at 1.4 milligram per square meter (mg/m2).
PEGPH20/Eribulin
PEGPH20 is designed to target the degradation of HA, a glycosaminoglycan and increases
blood flow to the tumor which may allow cancer therapies to be more efficiently delivered to their target. The drug accumulates around cancer cells, increasing tumor interstitial fluid pressure and constricting tumor vasculature, subsequently inhibiting anticancer agents from reaching cancer cells.

Eribulin is a microtubule dynamics inhibitor with a distinct binding profile that has been shown in in vitro studies to lead to apoptotic cell death after prolonged and irreversible mitotic blockage. Eribulin is currently approved for the treatment of advanced breast cancer in approximately 60 countries worldwide.

Both companies hope to see positive results from each phase of the trial in order to move forward with this collaboration of drugs.

For more information on the trial, click here.
HER2 Negative Breast Cancer
The HER2 gene makes HER2 proteins which are receptors on breast cells. Normally, HER2 receptors help control how a healthy breast cell grows, divides, and repairs itself. But in about 25% of breast cancers, the HER2 gene doesn't work correctly and makes too many copies of itself (known as HER2 gene amplification) or the breast cancers have little or no HER2 protein (HER2 Negative Breast Cancer).

http://www.raredr.com/news/Her2-Patient-Dosed