Grand Rounds 2005
Download
1 / 17

inovio - PowerPoint PPT Presentation


  • 198 Views
  • Updated On :

Grand Rounds 2005. Paul Goldfarb, M.D . Inovio’s Proprietary Medpulser ® System. Generator: • Capable of several thousand treatments • Generates square wave DC current. Applicator: • One per patient/treatment

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'inovio' - ostinmannual


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Slide1 l.jpg

Grand Rounds 2005

Paul Goldfarb, M.D.


Inovio s proprietary medpulser system l.jpg
Inovio’s Proprietary Medpulser® System

Generator:

• Capable of several thousand treatments

•Generatessquare wave DC current

Applicator:

• One per patient/treatment

• Usage restricted by smart-chip

• Sizeable gross margin


Family of applicators l.jpg
Family of Applicators

Adjustable length applicators utilize their needle shield to adjust needle length by twist clicking into stops set from 0 to 3cm in 0.5cm increments.

Adjustable angle applicators

allow the angle of the needle probe to applicator handle

to be infinitely adjusted from 0º to 90º, permitting the physician to treat tumors on the lateral aspect of organs.


Therapeutic platform based on electroporation l.jpg
Therapeutic Platform Based on Electroporation

Electroporation

DC

Cell Membrane

After Pulse

(Cell returns to original state)

Cell Membrane

During Pulse

Cell Membrane

Before Pulse

Electroporation applies brief electrical pulses, inducing pores to open in the cell membrane and dramatically increasing uptake of useful drugs, genes & DNA vaccines

A simple and effective system of delivering drugs or genes into cells


Cancer therapy procedure utilizing ept l.jpg
Cancer Therapy Procedure Utilizing EPT

Injection of

Bleomycin

Electroporation Therapy (EPT)

DC

Electroporation

Pulsing the

Tumor withapplicator

Cell Poration,

drug enters cells

Drug Surrounds

Tumor Cells

Cells Reseal

And Die

Very effective treatment requiring low level of technical skills


Ept pre clinical clinical experience l.jpg
EPT Pre-clinical & Clinical Experience

Tumor Type

in vitro

in vivo

human

ovarian

endometrial

prostate

hepaticellular carcinoma

Lewis lung carcinoma

non-small cell lung

fibrosarcoma

glioma

basal cell carcinoma

melanoma

Kaposi’s sarcoma

adenocarcinoma

squamous cell carcinoma

oral, head and neck

pancreatic

liver

EPT is efficacious across tumor types


Electroporation therapy in head and neck cancer l.jpg
Electroporation Therapy in Head and Neck Cancer

Patient 002: lateral tongue cancer

The tumor is injected with Bleomycin.


Electroporation therapy in head and neck cancer8 l.jpg
Electroporation Therapy in Head and Neck Cancer

Patient 002: EPT

Electroporation Therapy (EPT) is applied with the applicator.


Electroporation therapy in head and neck cancer9 l.jpg
Electroporation Therapy in Head and Neck Cancer

Patient 002: 4 weeks post EPT

The tumor has a definitive margin after 4 weeks.


Head neck cancer clinical data l.jpg
Head & Neck Cancer Clinical Data

Phase II, Recurrent Late Stage H&N Tumors: N.A. and Europe

Bleo Only

Bleo & EPT

Tumors Patients CR% PR%

37 25 0 3

Tumors Patients CR% PR% OR%

20 17 30 25 55

31 25 19 39 58

18 12 28 28 56

N. America IN. America II

Europe

69 54 26% 32% 57%

Total

Market Seeding, Newly Diagnosed H&N Tumors: Europe

CR = Complete Response : Tumor shrinkage of 100%

PR = Partial Response : Tumor shrinkage of 50% or greater

OR = Objective Response : Clinical Response +

Partial Response

NED = No Evidence of Disease at treatment site on histological examination 4 weeks post treatment

ED = Evidence of Disease

Tumors Patients NED ED

20 20 16 4

Europe

Patients had a complete response rate of 80%

Excellent response rate in newly diagnosed H&N cancer patients


Ept compared to surgery l.jpg
EPT Compared to Surgery

• Equivalent disease control

• Better tissue preservation

• Better function preservation

• Less cost


Inovio biomedical corporation l.jpg
Inovio Biomedical Corporation

Our Perception:

A NOVEL ABLATION SYSTEM THAT USES A WELL CHARACTERIZED DRUG IN A PREVIOUSLY APPROVED ROUTE OF ADMINISTRATION TO ABLATE MALIGNANT TISSUE AND SPARE NON-MALIGNANT TISSUES IN CONJUNCTION WITH A DEVICE THAT ADMINISTERS BRIEF LOCALIZED ELECTRIC PULSES.

Our Regulatory Pathway as defined by our RFD:

A COMBINATION PRODUCT WITH PRIMARY REVIEW BY CDER AND CONSULTATIVE REVIEW BY CDRH WITH A RECOMMENDATION TO CONSIDER 510-K SUBMISSION FOR THE DEVICE AT TIME OF REVIEW.


Inovio biomedical corporation13 l.jpg
Inovio Biomedical Corporation

Original Phase III study design:

A standard survival based study in patients with end stage disease where all received systemic therapy and the study group received EPT. The primary endpoint was survival

Issues:

• A local therapy has no benefit if the total tumor burden is not addressed by the intervention.

• There is no clinical benefit [survival] to local therapy use in patients with end stage disease and this therapy would not be offered to patients in this clinical setting


Inovio biomedical corporation14 l.jpg
Inovio Biomedical Corporation

Current Phase III study design:

• A study comparing the efficacy of EPT to surgery in patients with localized recurrent disease or second primary disease

• The endpoint is enhanced preservation of function and appearance. Survival and local control will be no worse with EPT


Inovio biomedical corporation15 l.jpg
Inovio Biomedical Corporation

Bleomycin issues:

• A well characterized generic drug

• A Class 1 generic drug for parenteral administration

• The device acts with a class of drugs and not a “specific drug”

• Genetronics is not the MA holder for Bleomycin & will not bring the drug into commerce

• No interest on the part of current license holders to relabel the drug


Inovio biomedical corporation16 l.jpg
Inovio Biomedical Corporation

Resolution developed with the FDA:

• The label, included with each disposable applicator, will incorporate all relevant information regarding the use of the drug Bleomycin when used as part of an EPT procedure

• Genetronics will monitor the available formulations of bleomycin on a routine basis to ensure continued constancy of formulation. This is already assured by the drug classification

• The final approval will be through a PMA granted by CDRH with a collaborative review by CDER.


Inovio biomedical corporation17 l.jpg
Inovio Biomedical Corporation

Implications:

•New indications may not require relabeling of the drug and will be reflected in changes to the device label.

• Once initial safety issues related to Bleomycin have been reviewed by CDER, future efficacy assessments of this ablation technology might be reviewed by CDRH and approved as supplements to a PMA.

• THIS MODEL PROVIDES A INOVATIVE, FLEXIBLE, PATHWAY TO REVIEW AND APPROVE DRUG- DEVICE COMBINATION PRODUCTS THAT USE CERTAIN GENERIC DRUGS.


ad