EnGeneIC Announces Publication of Late-Stage Canine Brain Cancer Study Results in PLOS ONE

NEW YORK and SYDNEY, April 7, 2016 /PRNewswire/ -- EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, announced today that data from a preclinical study of its EDV™ nanocells in canines with late-stage brain tumors have been published in PLOS ONE, an international, peer-reviewed, scientific journal.

The paper, titled, "Targeted doxorubicin delivery to brain tumors via minicells: proof of principle using dogs with spontaneously occurring tumors as a model," evaluated the safety and efficacy of EGFR targeted, doxorubicin loaded EDV nanocells in 17 companion dogs diagnosed with Stage IV brain tumors. All of the dogs presented severe neurological signs and symptoms, including seizure, ataxia, partial limb paralysis, partial loss of peripheral vision, and aggressive behavior. Study participation was offered to the dogs' owners after they had declined euthanasia, which is the standard of care for late-stage canine brain cancers.

In the study, all 17 dogs received at least seven weekly intravenous injections of the EGFR-targeted, doxorubicin-loaded EDV nanocells, with a maximum of 98 repeated doses. Severe neurological signs and symptoms were completely resolved in all dogs after approximately 5-15 doses. Median overall survival was 264 days (range, 49 to 973) and the EDV nanocell treatment was found to be safe and extremely well-tolerated, with no severe adverse events observed.

Treatment response was evaluated in 15 of the 17 dogs, with two of the dogs unable to be evaluated. Overall, two dogs had complete responses, two had partial responses (>90% reduction in tumor volume), 10 had stable disease and one showed progressive disease. The objective response rate (ORR) for treatment was 23.53% (4 of 17 dogs; 95% confidence interval, 6.8-49.8%). Median survival for the four responding dogs was 654 days (range, 292 to 973). Of the 10 dogs with stable disease, median survival was 207.5 days (range, 49 to 822), including three dogs which survived longer than one year.

Himanshu Brahmbhatt, Ph.D., joint-CEO of EnGeneIC and one of the co-authors from the study, commented, "These results, paired with our first-in-man pilot study in glioblastoma, will be the  foundation for  our upcoming Phase 1/2 clinical trial of EGFR-targeted, doxorubicin-loaded EDV nanocells in recurrent glioblastoma to be conducted at premier US hospital. The marked anti-tumor response and regression of neurological symptoms observed in these animals with late-stage brain cancer show the potential use of EDV nanocells in the treatment of  human neurological tumors."

Full Reference: MacDiarmid, JA., et al. 2016. Targeted doxorubicin delivery to brain tumors via minicells: proof of principle using dogs with spontaneously occurring tumors as a model. PLOS ONE. http://dx.plos.org/10.1371/journal.pone.0151832

Funding: EnGeneIC Pty Ltd conceived, designed and funded this study. EnGeneIC Pty Ltd funded the salaries for authors JAM, STP, SLP, LRA, VNB, KS, MTH, MC, NBM, IS, NAG, DLK, HB. The specific role of these authors are articulated in the author contributions section.

Competing Interests:  EnGeneIC Pty Ltd funded the salaries for authors JAM, STP, SLP, LRA, VNB, KS, MTH, MC, NBM, IS, NAG, DLK, HB. Authors JAM, HB, NBM, STP, SLP, RMG, BS are shareholders in EnGeneIC Pty Ltd. All other authors declare that no competing interests exist. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

About EnGeneIC and the EDV™ Nanocell Technology 
EnGeneIC is a clinical stage biopharmaceutical company focused on developing its proprietary bacterially-derived EDV™ nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform designed to directly target and effectively kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system's natural anti-tumor response. Intravenously injected EDV™ nanocells exit the leaky vascular system only found within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody. Once attached, the nanocell is able to enter the tumor cell and deliver a drug, siRNA, or miRNA payload at high concentrations, intracellularly. The EDV™ nanocell platform has shown promising results in early clinical studies and EnGeneIC is currently planning to commence further clinical trials in several cancer indications in Australia and USA.

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