delmar pharma reviews glioblastoma clinical trials and new therapeutic development (ceolive.tv...
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Glioblastoma is the most common form of brain cancer, and DelMar is developing VAL-083 in the U.S. and China to treat aggressive cancers Slides for a discussion on CEOLIVE.tv by Jeffrey Bacha, president and CEO of DelMar Pharma, a cancer-focused company developing new therapies for patients with little to no treatment options. DelMar's first drug in development is VAL-083, a potential first-in-class treatment for glioblastoma multiforme (GBM). Mr. Bacha will also discuss how the company is strategically advancing VAL-083 in the U.S., where the drug is in encouraging Phase I/II clinical trials for glioblastoma, and in China, where the drug is currently approved to treat lung cancer and chronic myelogenous leukemia (CML). Watch the interview here: http://www.ceolive.tv/delmarpharma Quotes: Jeffrey Bacha, president and CEO of DelMar Pharma, "We are testing VAL-083 in glioblastoma, where there is the greatest need and greatest potential impact, and we are running our studies as quickly as possible to get this promising drug into the hands of physicians to treat the patients who need it the most." Key Facts: - More than 15,000 people are diagnosed with glioblastoma each year in the U.S. - Approximately half of glioblastoma patients will fail the approved therapies - Many patients develop resistance to the front-line therapy, Temodar® ($950 million annual sales), because of an enzyme known as MGMT - VAL-083 acts through a mechanism independent of MGMT Interim clinical trial results presented at ASCO suggest VAL-083 may have an improved safety and dosing profile over current therapies - Studies by the National Cancer Institute and DelMar have shown VAL-083 to have activity against a range of cancers, including glioblastoma - DelMar is conducting a Phase I/II clinical trial for VAL-083 at UC San Francisco and the Sarah Cannon Research Institute in Nashville, Tennessee and Sarasota, Florida - VAL-083 has received orphan drug designation in Europe and the U.S. About DelMar Pharmaceuticals Del Mar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive clinical research sponsored by the U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action. For more information, please visit www.delmarpharma.com or follow us on Twitter @delmarpharmaTRANSCRIPT
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
OUR MISSION To benefit pa?ents and create shareholder value by rapidly developing and commercializing well-‐validated an?-‐cancer therapies in high-‐impact orphan cancer indica?ons where pa?ents have failed modern therapy. OTCQB: DMPI
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
Glioblastoma Mul?forme (GBM) VAL-‐083 Showing Promising Results in Phase 1/2 Clinical Trial
• Most common and aggressive form of brain cancer
• Affects ~15,000 adults / year in US
• Approximately 50% of pa>ents tumors fail all other treatments
• VAL-‐083 has dis?nct mechanism from other treatments that suggests will be ac?ve where other drugs are failing
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
VAL-‐083: DelMar’s First Product Opportunity
• VAL-‐083 is a novel, first-‐in-‐class small-‐molecule chemotherapy with ac?vity in a wide-‐range of cancers
• Well studied in >40 previous human clinical studies at Na?onal Cancer Ins?tute (NCI)
• Approved cancer chemotherapy in China to treat lung cancer & leukemia
• Favorable safety and dosing profile; fewer side effects; dis?nct mechanism of ac?on
• Commercial scale manufacturing in place
• Solid intellectual property posi?on
©2013 -‐ DELMAR PHARMACEUTICALS
DelMar Is Rapidly Advancing VAL-‐083 to Treat Aggressive Cancers; Key Time in Development
• Ini>ated U.S. clinical trial in refractory glioblastoma (GBM) 4Q11
• FDA grants orphan drug status in GBM 1Q12
• Interim Phase 1/2 clinical trial data presented at ASCO13 2Q13
• Expanded clinical trial to UCSF (3rd site) • FDA allows accelerated dosing • USPTO grants key patent for VAL-‐083
3Q13
• Presen?ng at Society of NeuroOncology (SNO) 4Q13
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
Building Value: Advancing Clinical Development in USA
• 2013: Complete dose-‐escala?on & define registra?on trial design in refractory GBM
• Society for NeuroOncology Mee>ng (SNO) • November 21-‐24
• 2014: Ini?ate registra?on-‐directed trials in refractory GBM
• An>cipated design: 80-‐100 pa>ents; open label; PFS6 & radiographic response as primary endpoints
• Key Conferences: AACR / ASCO / SNO
All refractory GBM clinical trials are expected to be open label design enabling presenta?on of interim data at key conferences throughout development.
December 2011
May 2013
By February 2012, 50% reduc>on in tumor mass observed on MRI. Reduc>on maintained as of August 2013.
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
VAL-‐083: Product Development Strategy
New IP
Clinical Valida?on
: >40 NCI
Sponsored Clinical Trials
-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐ Approved
Drug in China
Addi?onal Indica?ons
China (approved)
Orphan Drug Approval(s)
Clinical Data Creates New Revenue & Partnering Opportuni?es
GBM (Phase II – USA)
Solid Tumors
Orphan Drug Approval
Big-‐Pharma Collabora?on
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
Glioblastoma Mul?forme (GBM) VAL-‐083 Showing Promising Results in Phase 1/2 Clinical Trial
• Large market opportunity • 2nd + 3rd line therapy: = $200M -‐ $500M annual sales • Front line therapy: > $1B annual sales
• DelMar’s clinical and non-‐clinical data supports VAL-‐083 ac?vity where other treatments fail • American Associa>on of Cancer Research (AACR): 2012 & 2013 • Society for NeuroOncology (SNO): 2012
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
VAL-‐083 Is Approved in China for Lung Cancer and Chronic Myelogenous Leukemia
Commercial and development partnership with Guangxi Wuzhou Pharmaceu?cal Group Co. Ltd. • Provides DelMar with global rights to VAL-‐083
• Near-‐term revenue opportunity for DelMar in high-‐growth interna>onal markets
• Guangxi Wuzhou Pharma will fund any clinical ac>vi>es in China
• DelMar plans to partner China marke>ng rights to access an established sales force and generate royalty revenue
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
• Lung cancer = 1,000,000 new cases annually by 2025
• Challenge: current sales of VAL-‐083 in China are minimal
• Drug is not well posi>oned vis-‐à-‐vis standard of care in approved indica>ons
• Solu>on: re-‐posi>oning and re-‐launch
• Support sales growth with Specific Data
• Support sales growth with Appropriate Promo>ons
• Guangxi Wuzhou Pharma will fund any clinical ac>vi>es in China
Expanding VAL-‐083 Market Opportunity in China for Near Term Revenue Opportuni?es
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
2013 Corporate Goals: Building Value
1. Advance VAL-‐083 Clinical Development in USA Ø Complete dose-‐escala>on por>on of Phase I/II GBM clinical
trial and posi>on to begin registra>on studies
2. Realize Commercial Opportunity of VAL-‐083 in China
Ø Enter into marke>ng partnership & develop new data to support commercial reposi>oning and re-‐launch
Ø 2014: Begin developing new clinical data to support sales growth
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
Stay in Touch with DelMar Pharma
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www.delmarpharma.com
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@delmarpharma
©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010
Strong Product Opportunity: Value for Pa?ents and Shareholders
• VAL-‐083 is well-‐validated: Safety profile & efficacy established
• Management has a history of successful exits: Matrix, ChemGenex
• Team successfully developed Synribo®: FDA approved by TEVA in 2012
• Hold VAL-‐083 China commercial rights: Near-‐term revenue opportunity
• Streamlined clinical and global commercializa?on plan: Near-‐term value
• Strong financial posi?on: Funding thru Q1’2015
• OTCQB: DMPI