Synthetic Biologics, Inc. - FORM 8-K - EX-99.1 - POWERPOINT PRESENTATION

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file	filename
8-K - ADEONA PHARMACEUTICALS--FORM 8K - Synthetic Biologics, Inc.	s22-9533_8k.htm
EX-99.2 - PRESS RELEASE, JANUARY 12, 2010 - Synthetic Biologics, Inc.	s22-9533_ex992.htm
EX-99.3 - PRESS RELEASE, JANUARY 8, 2010 - Synthetic Biologics, Inc.	s22-9533_ex993.htm

AMEX: AEN

OneMedForum 2010

January 13, 2010

Forward Looking Statements

AMEX: AEN

the leader addressing

subclinical zinc deficiency

and

chronic copper toxicity

in the

mature population

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NYSE-Amex Listed: AEN

Founded 2001

$6MM Personally Invested by Chairman

Went Public October 2006

$21MM @$2.00/share 2006-2007

Current Market Cap: $25MM @ $1.19 share

Daily Volume 725,000 shares/day

21MM Primary Outstanding Shares

+3MM Warrants & Options ($1.51 Avg. Exercise Price/Share)

$3,600,000 cash on hand 9/30/09

Average Burn Rate/Qtr. ~$790K

Adeona Corporate Overview

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Launch Date/Status

HartLab: CLIA Certified Reference Lab 7/10/09

CopperProof™ Diagnostic Panel 11/9/09

Zinthionein™ ZC GS-150 Q1 2010

Zinc-Monocysteine GRAS Process

Oral Estriol for MS Phase II/III

Oral dnaJP1 for RA Phase II Completed

Oral Flupirtine for FMS Phase II IND Approved

Product Pipeline

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David A. Newsome, M.D.
President, HealthMine Subsidiary

Training:

Duke University, A.B.

Columbia University, M.D.

Harvard Medical School, Ophthalmology Residency

(Massachusetts Eye and Ear Infirmary)

Harvard Medical School, Retina Disease and Surgery Fellowship

Bascom Palmer Eye Institute, Retina Disease and Surgery Fellowship

Research & Faculty Experience:

– National Eye Institute (NIH)

• Chief, Retinal Disease Section

– Johns Hopkins, Wilmer Eye Institute, Associate Professor

– LSU Eye Center, Professor

• Author, 150 Peer-Reviewed Publications and 2 books

– Originated Zinc Hypothesis for Age-Related Macular Degeneration

– 1988, Published First Clinical Trial, “Oral Zinc Supplementation for Age Related
Macular Degeneration”

– Currently marked as “Preservision”, “Ocuvite” “iCaps”

• 2008 Sales ~ $300MM, B&L and Alcon

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George J. Brewer, M.D.
Co-Founder, Chair SAB

• Chairman Emeritus, Department of Human Genetics, University of
Michigan

• Foremost Authority on Chronic Copper Toxicity - Wilson’s disease,
>500 Publications

• Member, EPA-Convened National Academy of Sciences -
Committee on Copper in Drinking Water (2000)

• Drawbacks of Galzin®/Wilzin®:

– Nausea in 90% of Patients, G.I. Irritation in 30% of Patients

– 3X/day dosing away from meals

• Co-inventor, Adeona Modified-Release Oral Zinc Technology

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Galzin is a registered trademark of Gate Pharmaceuticals Inc.

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Diseases of Confirmed or Suspected
Copper/Zinc Dyshomeostasis

DISEASE	U.S. PERSONS
Wilson’s Disease	10,000
Dry Age-Related Macular Degeneration	17,000,000
Alzheimer’s Disease	5,800,000
Mild Cognitive Impairment	15,000,000
Parkinson’s Disease	400,000
Complications of Diabetes	23,000,000
Estimated Total U.S. Persons	50,000,000

Copper’s
Involvement
in
Alzheimer’s
and Mild
Cognitive
Impairment

(COPPER)

(Copper)

Courtesy: NIA;

“Copper” Text Added.

5.3 Million Miles of Copper Tube in U.S.

Current EPA Limit of Copper in Water:
1.3mg/L

Average Home has About 1/10th the EPA Limit

Copper-Containing Multivitamins and
Cognitive Decline in the CHAP Study (2006)

• Chicago Health and Aging Project (CHAP)

• 3718 Chicago Residents over Age 65

• Cognition Tested at 0, 3 and 6 Years

• Copper-Containing Multivitamin Consumption
Noted and Compared

• Consumers of Copper-Containing
Multivitamins (i.e. 2mg/day) with a High Fat
Diet had 6.51 Times the Rate of Cognitive
Decline than Persons not taking Copper-
Containing Multivitamins

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Morris MC et. al., Arch. Neurol. Vol. 63;1085-8 (Aug 2006)

Chicago Health and Aging Project (CHAP)

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Serum Copper Dyshomeostasis in AD & MCI

Free Copper Ions	0	0.0001
Homocysteine	<10	<0.5%
Ferroxidase II	<10	<0.5%
Extracellular SOD	<10	<0.5%
Factors V and VIII	<5	<0.5%
Metallothionein	<1	<0.1%
15-60kDa Proteins	40	<0.5%
Small Peptides	35	<0.5%
Albumin	150	15%
Ceruloplasmin	700	70%

µg/L

Copper

Bound

Cerulo-

Plasmin

(Cp)

Free

Copper

Bound

Cerulo-

Plasmin

(Cp)

Free

Copper

Normal

Wilson’s

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Free

Copper

Bound

Cerulo-

Plasmin

(Cp)

Alzheimer’s
& MCI

Linder et. al.

Serum Copper/Zinc Dyshomeostasis in
Alzheimer’s Disease

• Elevated Percent Serum Free Copper in AD

– Distinguishes AD from Normals (Squitti et. al. 2005)

– Prognostic for Cognitive Decline (Squitti et. al Jan. 2009)

– Correlates with Cognitive Loss (Arnal N, et. al. Dec. 2009)

• Defective Ceruloplasmin (Squitti et. al. Jan. 2008)

CopperProof-1 Study

• 90 Subject Prospective, Observational, IRB-Approved
Randomized Comparative Study

• Sponsored by Adeona

• The Alzheimer’s Center at Albany Medical Center - P.I. Earl
Zimmerman, M.D.

• 30 Alzheimer’s, 30 Parkinson’s, 30 Age-Matched Normals

• Patients Recruited 2007-2008. Analysis Q1 2009

• Results Presented at ICAD (International Conference on
Alzheimer’s Disease) July 15, 2009

• Acquisition by Adeona - July 10, 2009

• CLIA-Certified Laboratory, Chicago

• Launched CopperProof™ Panel - Nov. 2009

• Serum-Based Copper/Zinc Diagnostic Panel

• Diagnose and Grade Patients with
Copper/Zinc Dyshomeostasis (AMD, AD, MCI,
PD etc.)

• Dx-Rx Strategy - Zinthionein™ ZC GS-150

Zinthionein™ ZC GS-150 Oral Zinc

Gastroretentitive/Sustained Release Oral High Dose Zinc
Preparation

Convenient Once-a-Day Dosing (vs. 3X Galzin® or 2X
AREDS)

Broad Patent Protection Anticipated

100% GRAS Ingredients

Highest Single Dose Bioavailability of Oral Zinc in Humans

Extended Sustained Serum Zinc Levels Maintained

Proximal Metallothionein Induction

Intended Lower Instance of Nausea and Gastric Irritation
(vs. 90% for Galzin® at 1/3 Dose)

Planned Launch this Quarter

• Medical Foods:

– Legislation Section 5 of Orphan Drug Act

– GRAS Ingredients “Intended fro the Dietary
Management of Disease or Condition not
Satisfied by Normal Diet Alone”

– Exempt from NDA Requirements

– Must be Sold Under Doctors’ Supervision

• Prescription Product

• Distributed through Pharmacy Distribution
Chain

– Reimbursement Generally Available

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CopperProof-2 Clinical Trial

• First Controlled Clinical Trial of Zinc therapy for AD or MCI

• 60 Patient, Two Part, Double Blind, Randomized Placebo Controlled
Trial of Once-Daily Zinthionein™ ZC GS-150 in AD and MCI Patients with
Impaired Serum Copper/Zinc Status

• P.I. Diana Pollack, Alzheimer’s Center - Clearwater Hospital, Florida

• IRB Approved November 2nd, 2009

• 30 Day Washout Period for Copper Supplements

• Part I: Single Day Comparison to Galzin® and Placebo

– Endpoint: Improved bioavailability and tolerability

• Part II: 6 Month, Double Blind Randomized Placebo Controlled Study

– Endpoint: Cognition, MMSE and ADAS-Cog at 3 and 6 months

• Initial Data Expected Next Month (February)

* Zinthionein™ ZC contains 150mg elemental zinc
and does not contain zinc-monocysteine.

- Issued Composition of Matter Patents

• U.S. Patent 7,164,035, Issued Jan. 16, 2007

• U.S. Patent 6,586,611, Issued July 1, 2003

– Additional pending patents pending

– Modified Release Zinc - GR, SR, High Dose, Once-Daily

– Combination formulas

– Copper-free formulas

– Pill dispenser that incorporates eye self-test

– Serum based diagnostic assays

– Trademarks:

• Zinthionein®, Eyedaily®, (888) EYE-DAILY,
www.eyedaily.com

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ADDITIONAL CLINICAL PROGRAMS
FOR WHICH ADEONA IS SEEKING
BUSINESS DEVELOPMENT
OPPORTUNITIES

TRIMESTATM (oral estriol) for Multiple Sclerosis

• Approved in Europe & Asia for 40 years (No U.S.)

• Oral Version of Endogenous Pregnancy Hormone

– Estriol or E3

• First Potential Oral Treatment for MS

• Developed by Rhonda Voskuhl M.D.

– Chair UCLA MS Neurology Center

• Exclusively Licensed from UCLA

• Believed to be Responsible for:

– Fetal Immune Privilege

– Spontaneous Remission of Autoimmune Diseases

• Completed 22 Month Phase IIa Clinical Trial under
funding from the NMSS

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79% Reduction in MRI Lesions @ 3 Months (p=0.02)
Lower number of lesions and lower lesion volume while on Trimesta

New Enhancing Lesion Numbers

New Enhancing Lesion Volumes (mm3)

TRIMESTA (19-22)

Post Tx (16-18)

Post Tx (13-15)

Pre Tx (1-6)

Months Tx

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Improvement In Cognitive Function By
14% in 6 months (p=0.04)

6 RR Trimesta Tx (month 12)

6 RR Pre Tx (month 3)

4 SP Trimesta Tx (month 12)

4 SP Pre Tx (month 3)

All 10 Trimesta Tx (month 12)

All 10 Pre Tx (month 3)

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TRIMESTA™ Phase II/III Clinical Trial

• Phase II/III Clinical Trial In MS

– 150 Patients, 71 Enrolled

– 16 U.S. Centers

– Double-Blind, 1:1 Placebo Design with Copaxone as Standard of Care

– Female Relapsing-Remitting Patients

– Funded by $5 Million NIH/National MS Society Grant

• Largest Clinical Grant Ever Awarded by NMSS

• Recent Additional $860,000 Grant under ARRA

– Primary Endpoint

• Relapse Rate at 2 Years with Interim Analysis at 1 Year

– Secondary Endpoints

• Cognitive Tests-PASAT

• NAA levels

• MRI

• Hippocampus volume

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Oral mucosal route induces immune tolerance

to the epitope-specific antigens

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•Double-Blind, Placebo-Controlled Phase II Clinical Trial

•Active RA patients

•Background Therapy Medications Allowed

•11 Clinical Centers

•Stanford, UCSD, U. Arizona, John Hopkins, Mayo Clinic

•Daily oral administration, 6 months

•160 patients: 1:1 randomization

•Enrollment criteria based on presence of both immunological reactivity to HSP-
dnaJP1 and clinically active disease

•Endpoints:

•Clinical Endpoints: ACR 20, ACR50

• ACR20: FDA approvable endpoint

•Immunologic Endpoints

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Published Results of Phase II Study

• dnaJP1 appeared to be safe and well-tolerated.

• There was a significant reduction in the percentage of T cells producing the
proinflammatory cytokine tumor necrosis factor alpha (TNF-alpha) (p < 0.0007).

• The primary efficacy end point (meeting the American College of Rheumatology
20% improvement criteria at least once on day 112, 140, or 168) showed a
difference between treatment groups (p=0.09) that became significant in post hoc
analysis using generalized estimating equations (p=0.04).

• Differences in clinical responses were also found between treatment groups on
day 140 and at follow up, indicative a durable response following discontinuation
of therapy.

Arthritis & Rheumatism, Nov. 2009

• Oral flupirtine

– Developed by Andrew Stoll M.D.

• Experimental Pharmacology, McLean Hospital/Harvard University

– Oral flupirtine, marketed in Europe since 1984

• Potassium Channel Modulator

• In-direct NMDA receptor antagonist

• Non-opioid, centrally acting analgesic compound

• New mechanism of action

– Issued U.S. Patent, pending international patents

– Pilot human results in refractory fibromyalgia patients

• ~24 patients in fibromyalgia

• ~150 patient clinical results in glaucoma, retinitis pigmentosa, diabetic retinopathy

– Phase II ready clinical trial in refractory fibromyalgia

• IND Approved

• IRB Approval Received

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Steve H. Kanzer, CPA, JD

Chairman

Adeona Pharmaceuticals, Inc.

3930 Varsity Drive

Ann Arbor, Michigan 48108

Phone: (734) 332-7800

Fax: (734) 332-7878

www.adeonapharma.com

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