Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Adherex Technologies — Investor Presentation (June 2013)
19 slides from Fennec Pharmaceuticals's investor presentation, June 2013
Slide 1: Corporate Presentation June 2013
Corporate Presentation June 2013
Slide 2: Safe Harbor Statement
Safe Harbor Statement During the course of this presentation we will make statements that constitute forward-looking statements. These statements may include operating expense projections, the initiation, timing and results of pending or future clinical trials, the actions or potential action of the
Slide 3: Company Overview
Company Overview Biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics Two late stage oncology clinical products: Sodium Thiosulfate (STS) and Eniluracil (EU) STS: pending favorable data will file for NDA EU: pending partnering discussions advance to Phase
Slide 4: Management and Board of Directors
Management and Board of Directors Rosty Raykov – CEO Bear Stearns, Tiedemann Group, John Levin & Co., Alchem and DCML Co. Robert Andrade – CFO Bear Stearns, JP Morgan, CIBC, Caxton Associates, Millennium Partners and DCML Co. David Lieberman – Chairman Donaldson, Lufkin & Jenrette, Tiedemann Group.
Slide 5: STS Investment Highlights
STS Investment Highlights STS is a chemo-protectant agent being developed exclusively in children to prevent hearing loss caused by cisplatin Received Orphan Drug Designation in 2004 with 7 years exclusivity upon approval Phase III trial conducted by Children’s Oncology Group is fully enrolled with
Slide 6: Platinum Hearing Loss is Frequent, Severe and Irreversible
Platinum Hearing Loss is Frequent, Severe and Irreversible Platinum drugs are broady used agents in pediatric oncology Produce profound, irreversible, cumulative hearing loss Destroy the cochlear hair cells of inner ear Effect can be seen after as little as the second or third dose Hearing loss (oto
Slide 7: Ototoxicity in Children Treated with Cisplatin and/or Carboplatin
Ototoxicity in Children Treated with Cisplatin and/or Carboplatin 100 61% bilateral hearing loss (ASHA criteria) at 80 88 Ototoxicity (%) the end of treatment 75 41% required hearing 60 67 aids that only partially restore hearing 40 50 22% of patients had dose reductions due to 20 ototoxicity 11 N=6
Slide 8: Current Approach to Platinum Induced Hearing Loss
Current Approach to Detectable hearing loss generally begins after about two or three Platinum Induced cycles of cisplatin, and may continue to occur for months (or Hearing Loss longer) after use is discontinued Hearing Loss Detected or Hearing Loss Communicate Diagnosed d by Patient Continue Dose M
Slide 9: Target and Proposed STS Mechanism
Target and Proposed STS Mechanism Requires both Cl unbound to crosslink DNA Antitumor Effect Binding to plasma proteins NH3 occurs within first hour which Cl inactivates one binding site NH3 Pt Free cDDP (unbound) short Cl t1/2 :1.5 hr Requires one Cl unbound to Ototoxicity Effect affect cochlear ha
Slide 10: STS Protects Against Cisplatin Ototoxicity in the Rat
STS Protects Against Cisplatin Ototoxicity in the Rat Change from baseline hearing threshold. Effect of STS (8 g/m2 IV) 4 hrs, 8 hrs, or 12 hrs after administration of cisplatin (6 mg/kg IA) Delayed administration of STS after platinum agents in animals reduces ototoxicity
Slide 11: Cisplatin and STS animal PKs
Cisplatin and STS animal PKs Cisplatin clearance is complete by 6 hrs with or without STS, when STS levels are at or higher than clinically achievable levels Cisplatin Pharmacokinetics STS Pharmacokinetics nu/nu mice administered 4 mg/kg CDDP i.p. nu/nu mice administered 3.5 g/kg STS i.p. STS Level
Slide 12: Time-Dependent Tumor Protection of STS after Administration of Cisplatin in Nude Mice
Time-Dependent Tumor Protection of STS after Administration of Cisplatin in Nude Mice STS allows for anti-tumor activity when given properly Harned TM et al. Clin Cancer Res 2008;14:533-540
Slide 13: COG ACCL0431: Randomized Study of STS for Prevention of Cisplatin-induced Hearing Loss
COG ACCL0431: Randomized Study of STS for Prevention of Cisplatin-induced Hearing Loss Newly diagnosed children with hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma Study Chair: David Freyer, DO, MS 135 randomized patients fully enrolled in 1Q2012 Futility analysis
Slide 14: COG ACCL0431: Randomized Study of STS for Prevention of Cisplatin-induced Hearing Loss
COG ACCL0431: Randomized Study of STS for Prevention of Cisplatin-induced Hearing Loss Note: Patient must first be Newly diagnosed germ cell Audiology done with enrolled on the COG hearing tumor, hepatoblastoma, medullo each cycle of therapy assessment Diagnosis blastoma, neuroblastoma, or study, AC
Slide 15: SIOPEL 6: Efficacy of STS in Reducing Ototoxicity
SIOPEL 6: Efficacy of STS in Reducing Ototoxicity in Patients Receiving Cisplatin for Standard Risk Hepatoblastoma Newly diagnosed children with standard risk hepatoblastoma Study Chair: Peppy Brock, MD 78 randomized patients fully enrolled out of 102 Interim evaluations of efficacy of the chemother
Slide 16: SIOPEL 6: Efficacy of STS in Reducing Ototoxicity
SIOPEL 6: Efficacy of STS in Reducing Ototoxicity in Patients Receiving Cisplatin for Standard Risk Hepatoblastoma D R Diagnostic biopsy E A N cDDP 80 mg/m2 L cDDP Tumour storage D 4 Cycles A 2 Cycles Radiological O Y staging E M D RRR if required I S Registration to S A cDDP 80 mg/m2 remote data en
Slide 17: STS: Development Timeline
STS: Development Timeline Event Timing FDA Type C Clinical Development Meeting March 2011 Presented to Pediatric ODAC ODAC recognized challenge of demonstrating STS does not reduce Nov 2011 efficacy of cisplatin and agreed adult study would not be appropriate COG ACCL0431 Clinical Data 3Q 2013 F
Slide 18: STS Market Opportunity
STS Market Opportunity Pediatric Market Opportunity 12,000 children develop cancer in the US every year 2,000 children will receive platinum-based chemotherapy, 3x ROW Pricing to be determined based on available therapies in the market Competitive Position Significance of injury increases value of S
Slide 19: Summary
Summary STS has Two Potential Near Term Value Drivers Positive data from COG Phase III trial will potentially support NDA filing Upon approval of NDA, receipt of Rare Pediatric Disease Voucher Eniluracil is active and well tolerated Indications where 5-FU is administered potentially in excess of $1
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