EnGeneIC and Asbestos Diseases Research Institute Initiate MesomiR-1 Phase 1 Trial in Patients with Late Stage Mesothelioma

Exploratory Study is First to Evaluate Novel microRNA Replacement Therapy for the Treatment of Malignant Pleural Mesothelioma

First Clinical Trial Evaluating EDV™ Nanocells Packaged with microRNAs

Nov 10, 2014, 08:10 ET from EnGeneIC, Ltd.

SYDNEY, Nov. 10, 2014 /PRNewswire/ -- EnGeneIC, Ltd., an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics and other therapeutic molecules, announced today that, together with the Asbestos Disease Research Institute (ADRI), it has initiated the first clinical trial evaluating its bacterially-derived and antibody-guided EDV™ nanocells packaged with microRNA for the treatment of patients with malignant pleural mesothelioma (MPM). The study is the first time a targeted nanotherapeutic approach to microRNA replacement is being tested in patients with MPM.

EnGeneIC's EDV™ nanocells will be packaged with miR-16 microRNAs, which were discovered to be missing in MPM cells by Professors. Glen Reid and Nico van Zandwijk of the ADRI. To deliver the missing microRNAs to the cells, the EDV™ nanocells are designed to specifically target the epidermal growth factor receptor found on MPM cells and have been coined TargomiRs for this study.

The MesomiR-1 trial is an open-label, exploratory Phase 1 study of TargomiRs administered in escalating doses by intravenous infusion in patients with MPM who failed to respond to standard of care therapy. The primary study objectives are to establish the optimal dose of TargomiRs and to detect early signs of disease stabilization.  Patients will be carefully followed during an 8-week period of experimental treatment including measurement of quality of life, pulmonary function and changes in immune status.

Participating sites for the trial include the Northern Cancer Institute, Lifehouse at Royal Prince Alfred Hospital and Concord Repatriation Hospital, all in Sydney.

Dr. Himanshu Brahmbhatt, Joint-CEO of EnGeneIC, said, "We are excited to commence this trial since we believe that it is the first time a microRNA-based oncology therapeutic will be administered in a thoracic tumour with very limited treatment options and a very poor prognosis. It is also a tremendous opportunity for EnGeneIC to demonstrate the platform nature and versatility of the targeted EDV™ nanocell."

Professor Nico van Zandwijk, who will be the principal investigator for the MesomiR-1trial, remarked, "We have previously published that miR-16 expression was severely depleted in all MPM tumour samples tested, which results in tumours growing unchecked. We are extremely pleased to have teamed up with EnGeneIC to use its unique targeted nanocell to restore this functional nucleic acid and to demonstrate the safety of the approach in a group of patients in great need of more effective treatment. "

About EDV™ Nanocell Technology

EnGeneIC's bacterially-derived EDV™ nanocells are a powerful nanoparticle drug delivery system designed to directly target and effectively kill tumor cells with minimal toxicity, while at the same time stimulate the immune system's natural anti-tumor response.

Intravenously injected EDV™ nanocells exit the leaky vascular system only 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 payload of up to one million drug molecules per nanocell. In parallel, the bacterial cell wall of the nanocells stimulates key components of the immune system, which are then activated to seek out and destroy cancer cells.

About EnGeneIC, Ltd.

EnGeneIC is an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutic and other therapeutic molecules.  The company's lead technology platform, EDV™ utilizes antibody-targeted, bacterially derived, non-living "nanocells" to release high concentrations of chemotherapeutic agents, molecularly targeted drugs, and RNA-interference molecules directly into targeted tumor cells.  In doing so, EDVTM nanocells enable current cancer treatments to be more potent and far less toxic, while also offering a potential new means for treating drug-resistant cancers.  EnGeneIC is currently preparing an IND for FDA submission, with plans to launch a Phase1/2a clinical trial in recurrent glioblastoma patients in early 2015. Trials are also in planning stages for non-small cell lung cancer.

For more information please visit www.engeneic.com  

For EnGeneIC:
Jennifer MacDiarmid, Ph.D.
Joint-CEO and Director

Investor / Media Contacts:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. / Amy S. Wheeler
+1-212-375-2664 / +1-646-362-5750
jdrumm@tiberend.com / awheeler@tiberend.com