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Presented by: Michael H. Tardugno President and Chief Executive Officer. Celsion Corporation. 10 Mar 2008. 10220-L Old Columbia Rd Columbia MD 21046 NASDAQ: CLN www.celsion.com. Safe Harbor Statement.

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presented by michael h tardugno president and chief executive officer
Presented by:

Michael H. Tardugno

President and Chief Executive Officer

Celsion Corporation

10 Mar 2008

  • 10220-L Old Columbia Rd
  • Columbia MD 21046
  • NASDAQ: CLN

www.celsion.com

safe harbor statement
Safe Harbor Statement

Except for historical information, the statements made in this presentation are forward-looking statements involving significant risks and uncertainties. These risks and uncertainties, including those related to the future financial position and business strategy of the Company, are detailed in the Company’s filings with the Securities and Exchange Commission.

corporate mission
Corporate Mission

Celsion Corporation is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using heat-activated drug delivery systems in combination with focused heat energy to address cancers with high unmet needs.

celsion today
Celsion Today
  • Late stage clinical dev. company with written agreement with the US FDA for 2 Pivotal Trials
    • Phase III Primary Liver Cancer
    • Open Label, Pivotal Ph II for Recurrent Chest Wall Breast Cancer
  • Lysolipid thermally sensitive liposome platform provides pipeline opportunities
    • First drug, ThermoDox®, combines doxorubicin with LTSL
    • Second drug, docetaxel, in pre-clinical development
    • Third drug, carboplatin in late stage formulation development
  • Platform Development
    • LTSL Active targeting technology
    • LTSL Chemo plus Imaging Agent
    • High intensity focused ultrasound (HIFU) plus ThermoDox
  • Strong, exclusive IP from Duke Univ., extending to 2018; extension potential
  • Well Funded
    • Sufficient to substantially complete Phase III trial for HCC
  • ThermoDox represents significant commercial potential
promising pipeline
Promising Pipeline

Development

Program

2009

2010

2011

2006

2007

2008

ThermoDox® - Lead Compound

NDA Submission

FDA Approval

& Launch

Liver Cancer - HCC

Phase I Dose

Escalation & PK

SPA Phase III Randomized

Pivotal Trial

Phase II

Pivotal Trial

NDA Submission

& FDA Review

FDA Approval

& Launch

Breast Cancer - RCW

Phase I Dose

Escalation & PK

New Compounds - In Development

Liposomal Docetaxel

Feasibility

Optimization

Preclinical

Liposomal Platinum

Feasibility

Preclinical

Optimization

thermodox highlights
ThermoDox® Highlights
  • ThermoDox is Celsion’s 1st Drug on the Lysolipid Thermally Sensitive Liposome (LTSL) technology platform. LTSL enhances the efficacy of doxorubicin, a potent chemotherapeutic
  • Low development risk, fastest path to approval strategy
    • Clinical focus is on unmet medical needs providing an

accelerated registrational pathway

      • Primary Liver Cancer (HCC)
      • Recurrent Chest Wall breast cancer (RCW)
    • Phase I results suggest remarkable proof of clinical activity
    • Doxorubicin, well known, well characterized
      • Higher concentration at the tumor
      • Potential to improve safety profile
ltsl mechanism of action
LTSL: Mechanism of Action

Heat applied at hyperthermic temperature activates liposomes to rapidly release chemotherapeutic in targeted location in high concentrations

39 < T < 42°C

37°C

39 < T < 42°C

Leaky Tumor Vessels

Heat adds permeability

Mechanical release at 39 - 42 °C

Source: Duke University

thermodox delivers high concentrations of chemotherapy directly to tumor

30

25

60

20

50

15

40

10

30

20

5

10

0

0

20

25

30

35

40

45

50

ThermoDox® delivers high concentrations of chemotherapy directly to tumor

IN VITRO Drug release occurs at clinically

achievable temperature.

IN VIVO After 1 hour at 42°C, heat-sensitive

formulation delivered most drug to tumor.

Clinically heatable temperature range 39°C - 42°C

Free doxorubicin

Non temp sensitive liposome

Temp. sensitive liposome

ThermoDox™ drug released in 20 seconds at 42C

Total Doxorubicin in Tumor

(ng/mg)

% Doxorubicin Released

Bodytemperature37°C

DOXIL®

Temperature C°

34oC

42oC

thermodox preclinical results
ThermoDox®Preclinical Results

ThermoDox is dramatically more effective than existing formulations

DOXIL®

Free Doxorubicin

Relative Tumor Volume (V/V 0)

ThermoDox

All tumors regressed in ThermoDox

group.

Each line is an individual mouse with xenograph in treatment group.

thermodox for primary liver cancer hcc
ThermoDox® for Primary Liver Cancer (HCC)
  • Number 5 global cancer
    • 660,000 annual worldwide incidences
  • High mortality
    • Radiation and systemic chemotherapy ineffective
    • 80% of patients ineligible for curative transplantation or resection
  • Our thesis for ThermoDox in combination with RFA for HCC:
    • Radio-frequency ablation (RFA) is emerging as a standard of care for locally advanced non-resectable liver disease
    • ThermoDox with RFA may reduce the potential for recurrence at the treatment site
rf ablation thermodox combination
RF Ablation / ThermoDox® Combination

Ablated Tumor and 1 cm “Tumor-Free” Margin

Micro - metastases outside the ablation zone “kill” area. These are a potential site of recurrence if not treated

<50°C >39°C

ABLATED TUMOR

> 50°C

RFA PROBE

High concentration of doxorubicin deposited by ThermoDox in this thermal zone

13

phase i study thermodox rfa for liver cancer
Phase I Study: ThermoDox® + RFA for Liver Cancer
  • Phase I is complete
    • 2 Clinical Sites NCI (USA) and Queen Mary Hospital (Hong Kong)
    • Single dose treatment. MTD of 50mg/m² established
    • No unanticipated SAE or AE experienced
    • Evidence of clinical activity presented at the 2007 ASCO-GI Conference
  • Unique Imaging Features - Treatment zone enhanced with ThermoDox
    • “Comparison of maximum diameters of thermal lesions immediately post RFA and 30 and 40 days post procedure, showed significant differences in thermal lesion size with the addition of drug”

Pre-treatment

11 weeks post-treatment

20 weeks post-treatment

phase iii hcc program thermodox rfa v rfa alone
Phase III HCC Program: ThermoDox + RFA v RFA Alone

Phase III – FPI by Q1 2008 means the potential for 2011 approval

  • FDA agreement via Special Protocol Assessment
    • Progression Free Survival endpoint agreed for accelerated approval
    • Secondary endpoints: Time to Local Recurrence, Overall Survival
  • FPI March 2008
    • Approximately 600 subjects
    • Randomized blinded two arm controlled
  • Global Study, with majority enrollment Asia
    • USA & Canada
    • China & Hong Kong
    • Italy
    • Korea
    • Taiwan
thermodox for the treatment of recurrent chest wall breast cancer rcw
ThermoDox® for the treatment of Recurrent Chest Wall Breast Cancer (RCW)
  • Breast Cancer recurring in the chest wall affects 11-15,000 post mastectomy patients annually in the US.
  • Limited treatment options – no standard of care
    • Radiation alone and systemic chemotherapy are ineffective
  • Phase I clinical study at Duke University,
    • In combination with local hyperthermia, doxorubicin is concentrated at the lesion
    • Multiple cycles, up to 6
    • 11 patients enrolled to date (3 at 20mg/m2, 6 at 30, and 2 at 40)
    • Interim results presented by Duke at 2007 WCIO and ESHO conferences, updated at April 2008 ESHO, Munich.
    • Acceleration of study planned with the addition of NYU
thermodox hyperthermia rcw pivotal program
ThermoDox® + Hyperthermia RCW Pivotal Program
  • Phase II…Agreement with FDA for an Open Label pivotal Study
    • RCW study population
    • Unmet medical need
    • Endpoint other than survival
  • Study planned to begin by Q4 2008
    • Assumes Phase I MTD by Q3 2008
    • Up to 10 sites in the US
    • Powered at 100 patients
    • Potential to complete enrollment and achieve approval in 2010
slide18

ThermoDox®

Highly effective for RCW

Demonstrated efficacy of Clinical Response in Phase I study paving the way to a pivotal trial

Limited clinical options

Complete response

product pipeline ltsl as platform technology
Product Pipeline LTSL as Platform Technology
  • Drugs in development
    • LTSL Docetaxel
      • Preclinical efficacy established
      • Stable and scaleable formulation
    • LTSL Platinum
      • Formulation and stability in development
      • Efficacy in small animal models in progress
  • Platform Development Program
    • LTSL Active targeting technology
      • Combines an active targeting agent with ThermoDox
    • LTSL Chemo plus Imaging
      • Ensures therapeutic concentration
    • High intensity focused ultrasound (HIFU) plus ThermoDox
      • Broadens therapeutic reach
      • Non-invasive
      • Potential to address metastatic disease
financial summary millions
Financial Summary (Millions)
  • Cash and cash receivables $34
  • Expected 3 year operating ave. cash burn ~ $1.45 / mo.
  • Common shares outstanding 10.9
  • Market capitalization is ~ $55
  • Assets > $45
near term value catalysts milestones over the next 12 months
Near Term Value CatalystsMilestones over the next 12 months.
  • Report confirming studies docetaxel Q4 2007 
  • Affirmative response from FDA for Phase II RCW trial Jan 2008 
  • Affirmative SPA from FDA for Phase III HCC study Jan 2008 
  • First patient treated in Phase III HCC trial Q1 2008
  • Accelerate RCW study to establish MTD Q1 2008
  • Interim update of Ph I RCW at ESHO Apr 2008
  • First patent treated in pivotal RCW study Q4 2008
  • Docetaxel preclinical results Q4 2008
celsion investment highlights
Celsion Investment Highlights
  • Clinical stage oncology company with two anticancer products in multiple trials
    • Based on a proprietary tumor targeting technology
    • First drug, ThermoDox, in ongoing trials for two indications
      • Pivotal Phase III HCC agreed - Jan 2008
      • Initiate Pivotal Phase II RCW trial by Q4 2008
  • Technology platform is expandable, supporting added indications and therapeutics
  • Cash is sufficient to substantially complete our clinical program for 1 indication
  • New management team focused on clinical development and regulatory approval