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•©Nanospectra Biosciences 2011 •1

CALit2 UCI-Micro/Nanotechnology: The Human ImpactJohn Stroh CEO

Kevin McNerney COO

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Cancer Therapy – Precise Thermal Destructionof Solid Tumors through Nanotechnology by the infusion of goldnanoshells (AuroLase®)

Medical Device (Inert Particle, Laser)Broad Applications in CancerIncluding Head & Neck, Prostate Brain (Primary and Mets), Lung

Clinical Advantage - PrecisionTreat Irregular Shaped and Inoperable TumorsPreserve Critical StructuresUnique “Focal” Therapy

Adjunct Therapy Applications

•©Nanospectra Biosciences 2011

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808 nm Laser

AuroShell®Particles for IV Administration

Interstitial Fiber Optic

ProbeFDA cleared

Investigational(classified as a device by FDA)


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AuroShell®Particles for IV Administration

(classified as a device by FDA)

~150 nm


Targeted Precision• Tumor-Specific Ablation • Minimal Collateral Damage

Clinical Challenges Addressed• Inoperable• Non-Resectable• Non-Specific (e.g., Prostate)

Adjunct to Current Treatments• Radiation, Chemotherapy Enhancement

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Tumor

ResidualDisease

SurgicalMargin

TraditionalAblationZones


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BloodSupply

Normal TissueCells

• Particles Flow with Blood

• Cleared from Blood by RESBlood Vessel Lining


• tumor-specific accumulation:

BloodSupply

TumorCells

Tumor Blood Vessel


•Nanoshells absorb NIR, transduce to heat•Laser delivered via percutaneous optical fiber

BloodSupply

TumorCells

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Step 1: Particle Delivery by Infusion

Particle-Based Thermal Destruction

Tumor


Tumor

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Step 2: Energy Transduced by Particles



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Step 2: Energy Transduced by Particles



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35 °C

5 °C

∆T

Applicators

Tumor

ΔT (°

C)

LaserEmissionArea

HealthyTissue

Intravenous Particle DeliveryFiber Insertion in Control and TumorAblation of TumorNo Damage to Control

Particle-FocusedAblation


MRI of Live Dog Brain During Therapy

0%

20%

40%

60%

80%

100%

1 6 11 16 21 26 31 36 41 46 51 56

Days after tumor treatment

% S

urvi

ving

Sham Treatment (n=16)

Untreated Control (n=17)

AuroShell™ Treated (n=11)

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Passive Accumulation, Single Dose

BALBc Mice, CT26 Cell LineTreatment at ≈5 mm diameterEuthanize 1 cm diameter

>90% Complete Response

1Cancer Letters 209 (2004), p. 171-1762 Proc. Of SPIE (2005), Vol. 5689, p. 149-157


Sub-ablation temperatures improve efficacy of conventional therapies• Radiation• ChemotherapyTumor centers become hypoxic (lives w/ little oxygen).Hypoxic tumor cells are tough, resistant to radiation and chemotherapy.Heating hypoxic tissue increases blood supply and oxygenation. Increased blood supply allows better access by chemo agents.Increased perfusion also increases oxygen level. Radiation produces singlet oxygen which poisons the cell.


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Noted Healthcare Organizations • MD Anderson• Baylor University• University of Texas Austin• University of Texas Medical Branch• Texas VA• Cancer Treatment Centers of America

Commercial Collaborations• Sebacia (Duluth, GA)• NanoComposix (San Diego, CA)• Cytodiagnostics (Ontario, Canada)• Sigma Aldrich (US)


Incidence (Global)Head & Neck (>650,000) human trial (FDA IDE)* Prostate (>910,000) human trial (outside US)*Brain (>225,000) $1.3MM NCI dog study*Melanoma (>180,000) (pig study) * **Lung (>1.4MM) - CTCA**Colon (>1.2MM)Breast (>1.5MM) Pancreas (>200,000)Others

* Clinical Trial Open** Clinical Trial Planned – Cancer Treatment Centers of America

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Source: American Cancer Society


Licenses from Rice University, U Texas -Medical Branch, U Texas -Austin11 Issued US Patents

10 Licensed, 1 Owned3 Pending

Broad Protection in CancerAblationImagingSynergy with RadiationTumor Margin Identification


ManagementJohn Stroh: President, CEO & Director / Previously CEO of CryoCare & Neomatrix

Kevin McNerney: COO/ Previously VP Ops of CryoCare , LifePoint & PMI MBA, BSME

Glenn Goodrich PhD: VP Proc Dev & Chem / PhD Chem, Penn St, Post-Doc Rice

Jon Schwartz PhD: Dir of Clinical Ops / PhD Biophysics, MD Anderson Cancer Ctr

~6 total employeesAdvisory

Naomi Halas PhD: Co-Founder / Dir Laboratory for Nanophotonics, Rice Univ.

Directors David Anderson: Chairman of the Board / Formerly CEO of MithraGen COO of Tanox

Jennifer West PhD: Co-Founder / Prof. & Chair of Bioengr, Rice

Dave Bristol: Officer and Director of HCF Enterprises, Inc.

Patrick Pace MD: Managing Director at Citadel Securities


• Particle based therapeutics have enormous potential in addressing the failures of traditional therapeutics

• Venture investors funded over $800M in early stage Nanotechnology companies in 2010 with 54% going to NanoMedicine companies

• Many clinicians see nanotechnology as the ideal solution for the detection and treatment of many diseases.

• As more Nanotechnology companies emerge from successful clinical trials the level of venture investing will continue to accelerate

•©Nanospectra Biosciences 2010–Not to be copied, reproduced,

electronically saved or distributed •20

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