Photodynamic Therapy of Cancer: The Design and

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Transcript Photodynamic Therapy of Cancer: The Design and

Photodynamic Therapy of Cancer:

The Design and Characterization of Photosensitizing Agents

Angela Dann Monday, October 9, 2006

 History    Introduction – Process of Photodynamic therapy (PDT) – PDT to treat cancer Photosensitizing Agents – Requirements – Advancements Trials using PDT on tumor cells  Conclusions  Future applications

History

 Light used as therapeutic agent for 3000+ years – Egyptian, Indian, and Chinese civilizations – Psoriasis, rickets, vitiligo, skin cancer  Photodynamic Therapy (PDT) developed within the last century Nature 2003, 3 , 380.

Nature 2003, 3 , 380.

History

History

  Niels Finsen (late 19 – Red light to prevent formation and discharge of small pox postules – UV light from the sun to treat cutaneous tuberculosis – Nobel Prize 1903 th century) Oscar Rabb (100+ years ago) – Acridine in combination with certain wavelengths of light – Lethal to infusoria Nature 2003, 3 , 380.

History

   Herman Von Tappeiner, A. Jesionek – Defined photodynamic action – Topically applied eosin and white light W. Hausmann – 1 st studies with haematoporphyrin and light – Killed paramecium and red blood cells Friedrich Meyer-Betz (1913) – 1 st to treat humans with porphyrins – Haematoporphyrin applied to skin, causing swelling/pain with light exposure Nature 2003, 3 , 380.

History

 Samuel Schwartz (1960’s) – Developed haematoporphyrin derivative (HpD)  Haematoporphyrin treated with acetic and sulfuric acids, neutralized with sodium acetate  Lipson, E.J. Baldes – HpD localization in tumor cells, fluorescence  I. Diamond (1972) – Use PDT to treat cancer Nature 2003, 3 , 380.

History

 Thomas Dougherty (1975) – HpD and red light – Eradicated mammary tumor growth in mice   J.F. Kelly (1976) – 1 st human trials using HpD – Bladder cancer Canada (1999) – 1 st PDT drug approved Nature 2003, 3 , 380.

Introduction:

Process of Photodynamic therapy  Two individually non-toxic components brought together to cause harmful effects on cells and tissues – Photosensitizing agent – Light of specific wavelength Nature 2003, 3 , 380.

Introduction:

Reaction Mechanisms  Type 1: – Direct reaction with substrate (cell membrane or molecule) – Transfer of H atom to form radicals – Radicals react with O products 2 to form oxygenated  Type 2: – Transfer of energy to O 2 to form 1 O 2 Nature 2003, 3 , 380.

Introduction:

Reaction Mechanisms  Ratio of Type 1/Type 2 depends on: – Photosensitizing agent, concentration of substrate and O 2 , binding affinity of photosensitizing agent to substrate   Reactive oxygenated species (ROS) – Free radicals or 1 O 2 Half-life of 1 O 2 < 0.04 m s – Radius affected < 0.02 m m Nature 2003, 3 , 380.

Introduction:

Type 1 and 2 Reactions Nature 2003, 3 , 380.

Introduction:

Treatment of cancer  PDT best suited for: – Early stage tumors – Inoperable for various reasons  Limited success due to lack of specificity and potency of photosensitizing agents  Three mechanisms of tumor damage Nature 2003, 3 , 380.

Introduction:

Mechanism 1  Direct Photodamage to Tumors by ROS   Problems: – Non-homogenous distribution of photosensitizing agent within tumor – Availability of O 2  Reduction of O 2 within tumor cells presence during PDT Overcoming O 2 depletion: – Lower light fluence rate Nature – Pulse light delivery – allow re-oxygenation 2003, 3 , 380. J. of Nuclear Medicine 2006, 47 , 1119.

Introduction:

Mechanism 2  Vascular Damage – Blood vessels supply nutrients to tumor cells  Effects: – Microvascular collapse – Tissue hypoxia and anoxia – Thrombus formation  Associated with halting tumor growth  Angiogenic factors upregulated Nature 2003, 3 , 380. J. of Nuclear Medicine 2006, 47 , 1119.

Introduction:

Mechanism 3   Immune Response – Movement of lymphocytes, leukocytes, macrophages into treated tissue – Difference in reactions toward normal and tumor tissues – Upregulation of interleukin, not tumor necrosis factor a – Neutrophil – slows tumor growth Required to purge remaining cells Nature 2003, 3 , 380.

Photosensitizing Agents:

Requirements        Selectivity to tumor cells Photostability Biological stability Photochemical efficiency No cytotoxicity in absence of light Strong absorption – 600-800 nm – Good tissue penetration Long triplet excited state lifetime J. of Photochemistry and Photobiology A: Chemistry 2002, 153 , 245. Photochemistry and Photobiology 2001, 74 , 656.

Photosensitizing Agents:

Classes Porphyrin derivatives – Most widely used NH N    HN N Chlorins – Reduced porphyrins – Derivatives from chlorophyll or porphyrins Phthalocyanines – 2 nd generation – Contain diamagnetic metal ion Porphycenes – Synthetic porphyrins Pharmaceutical Research 2000, 17 , 1447.

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Photosensitizing Agents:

Examples Photofrin Foscan 5-Aminolevulinic acid (5-ALA) Mono-L-aspartyl chlorin e6 (NPe6) Phthalocyanines Meso-tetra(hydroxyphenyl)porphyrins (mTHPP) Texaphyrins Tin ethyl etiopurpurin (SnET2, Purlytin)

Photosensitizing Agents:

Photofrin   1 st clinical approval (1999) in Canada Bladder cancer treatment  Most commonly used photosensitizer  Destroys mitochondria  Dihematoporphyrin ether (DHE) – bis-1-[3(1-hydroxy-ethyl)deuteroporphyrin-8 yl] ethyl ether – Active component of HpD Photochemistry and Photobiology 2001, 74 , 656.

Photosensitizing Agents: Photofrin

 Partially purified haematoporphyrin derivative (HpD) – Mixture of mono-, di-, and oligomers – Twice as phototoxic as crude haematoporphyrin (Hp) – Crude Hp consists of range of porphyrins – Convert to HpD by acetylation and reduction using acetic and sulfuric acids, filtering, and neutralizing with sodium acetate Photochemistry and Photobiology 2001, 74 , 656. Nature 2003, 3 , 380.

Photosensitizing Agents: Photofrin

Limitations: – Contains 60 compounds – Difficult to reproduce composition – At 630 nm, molar absorption coefficient is low (1,170 M -1 cm -1 ) – Main absorption at 400 nm – High concentrations of drug and light needed – Not very selective toward tumor cells – Absorption by skin cells causes long-lasting photosensitivity (½ life = 452 hr) Nature 2002, 2003, 3 , 380. J. of Photochemistry and Photobiology A: Chemistry 153 , 245.

Photosensitizing Agents:

Advancements  Need to overcome limitations of Photofrin  New photosensitizers developed according to ideal situations – Increase specificity to tumor cells – Increase potency – Decrease time of sensitivity to sunlight after treatment

Photosensitizing Agents:

Foscan  Chlorin photosensitizing agent  Approved for treatment of head and neck cancer  Low drug dose (0.1 mg/kg body weight)  Low light dose (10 J/cm 2 )  Complications due to potency Nature 2003, 3 , 380.

Photosensitizing Agents:

5-Aminolevulinic acid (5-ALA)  Hydrophilic zwitterion at physiological pH  Approved for treatment of actinic keratosis and BCC of skin  Topical application most frequently used  Endogenous photosensitizing agent – 5-ALA not directly photosensitizing – Creates porphyria-like syndrome – Precursor to protoporphyrin IX (PpIX) Nature 2003, 3 , 380. Photochemistry and Photobiology Pharmaceutical Res.

2000, 17 , 1447. 2001, 74 , 656.

Photosensitizing Agents:

Mono-L-aspartyl chlorin e6 (NPe6)        2 nd generation hydrophilic chlorin Derived from chlorophyll a Chemically pure Absorption at 664 nm Localizes in lysosomes (instead of mitochondria) Reduced limitations compared to Photofrin Decreased sensitivity to sunlight (1 week) – ½ life = 105.9 hr Photodermatol Photoimmunol Photomed 2005, 21 , 72.

Photosensitizing Agents:

Phthalocyanines   2 nd generation Ring of 4 isoindole units linked by N-atoms  Stable chelates with metal cations  Sulfonate groups increase water solubility  Examples (AlPcS 4 , ZnPcS 2 ) – Aluminum chlorophthalocyanine sulfonate   More prolonged photosensitization than HpD Less skin sensitivity in sunlight Photochemistry and Photobiology 47 , 1119.

2001, 74 , 656. J. of Nuclear Medicine , 2006,

Photosensitizing Agents:

Phthalocyanines  Tetrasulfonated AlPcS 4 – Hydrophilic – Deposited in vascular stroma – Affects vascular system – indirect cell death  Disulfonated ZnPcS 2 – Amphophilic – Transported by lipoproteins – Direct cell death Photochemistry and Photobiology 47 , 1119.

2001, 74 , 656. J. of Nuclear Medicine , 2006,

Photosensitizing Agents:

Meta-tetra(hydroxyphenyl)porphyrins (mTHPP)        Commercially available as meta tetra(hydroxyphenyl)chlorin – (mTHPC) 2 nd generation Improved red light absorption 25-30 times more potent than HpD More selective toward tumor cells Most active photosensitizer with low drug and light doses Not granted approval Photochemistry and Photobiology 2001, 74 , 656. Int. J. Cancer 2001, 93 , 720.

Photosensitizing Agents:

Texaphyrins  Synthetic – porphycene  Water soluble  Related to porphyrins  Absorption between 720-760 nm (far red) – Sufficiently penetrates tissue Photochemistry and Photobiology 2001, 74 , 656.

Photosensitizing Agents:

Tin ethyl etiopurpurin  SnET2, Purlytin  Chlorin  Treatment of cutaneous metastatic malignancies  Results of phase III study (934 patients) not yet released Photochemistry and Photobiology 2001, 74 , 656.

PDT Trials on Tumor Cells:

Breast Cancer  Chest wall recurrences – problem with mastectomy treatment (5-19%)  Study: – 7 patients, 57.6 years old (12.6) – 89 metastatic nodes treated – 11 PDT sessions – Photosensitizing agent: (m-THPC) meta-tetra(hydroxyphenyl)chlorin  2 nd generation photosensitizing agent Int. J. Cancer 2001, 93 , 720.

PDT Trials on Tumor Cells:

Breast Cancer  Dosage: – Diode laser used to generate l = 652 nm  3 patients – 0.10 mg/kg total body weight – 48 hr under 5 J/cm 2  4 patients – 0.15 mg/kg total body weight – 96 hr under 10 J/cm 2 Int. J. Cancer 2001, 93 , 720.

PDT Trials on Tumor Cells:

Breast Cancer  Results: – Complete response in all 7 patients – Pain – 10 days, Healing – 8-10 weeks – Patients advised to use sun block or clothing to protect skin from light for 2 weeks  4 days after treatment – 1 patient with skin erythema and edema from reading light – 6 of 7 patients given medication for pain  Mostly based on size, not lightdose – Recurrences in 2 patients (2 months) Int. J. Cancer 2001, 93 , 720.

PDT Trials on Tumor Cells:

Skin Cancer  Traditional Treatments: – Surgery, electrodesiccation, cryosurgery, topical application of podophyllin or 5 fluorouracil, radiation  Problems: – High cost, scarring, pigmentation changes, pain, inflammation, irritation Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer  Most promising treatment using PDT – Skin highly accessible to light exposure  Most common method – Topical administration of 5-ALA – Non-invasive, short photosensitization period, treat multiple lesions, good cosmetic results, well accepted by patients, no side effects Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer Mechanism of 5-ALA use: – 5-ALA formed in vivo in mitochondria by condensation of glycine and succinyl CoA (catalyzed by ALA-syntase) – Subsequent reactions produce protoporphyrin IX (PpIX)  Converted to heme using ferrochelatase and Fe  Heme inhibits synthesis of 5-ALA – Excess administered 5-ALA passes through abnormal epidermis and converts to PpIX Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer  Mechanism (continued): – PpIX accumulates with minimized amount of ferrochelatase – Tissues with increased concentration of PpIX undergo phototoxic damage upon light exposure  3 PpIX is formed, energy transferred to create 1 O 2 – PpIX nearly completely cleared within 24 hr Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer Clinical Studies performed on superficial skin cancer types: – Actinic keratosis (AK) – Basal cell carcinoma (BCC) – Squamous cell carcinoma (SCC) – Bowen’s disease (BD)  Complete response (CR) – no clinical or histopathologic signs after follow-up  Minimal side effects Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer Pharmaceutical Research 2000, 17 , 1447.

PDT Trials on Tumor Cells:

Skin Cancer  Clinical trials with mono-L-aspartyl chlorin e6 (NPe6)  14 patients – 9 male, 5 female – 46-82 years old (64 yrs average) – BCC – 22 lesions, SCC – 13 lesions, papillary carcinoma – 14 lesions Photodermatol Photoimmunol Photomed 2005, 21 , 72.

PDT Trials on Tumor Cells:

Skin Cancer  Clinical trials (continued) – 5 different intravenous doses of NPe6 over 30 minutes (0.5 mg/kg – 3.5 mg/kg)  4-8 hr prior to light administration (due to number of lesions) – Light dose – 25-200 J/cm 2  Argon-pumped tunable dye laser set at 664 nm  Dose dependent on tumor size/shape Photodermatol Photoimmunol Photomed 2005, 21 , 72.

PDT Trials on Tumor Cells:

Skin Cancer Photodermatol Photoimmunol Photomed 2005, 21 , 72.

PDT Trials on Tumor Cells:

Skin Cancer Results: – 4 weeks later: 20 of 22 BCC – CR, 18 of 27 other – CR  CR – no evidence of tumor in treatment field  PR – >50% reduction in tumor size – Photosensitivity gone within 1 week (12 of 14)  3 patients – mild to moderate pruritis, facial edema or blistering, erythema, tingling   1 patient – severe intermittent burning pain 1 patient – erythema, edema, moderate pain (gone within 2 weeks) Photodermatol Photoimmunol Photomed 2005, 21 , 72.

Conclusions

 PDT of cancer regulated by: – Type of photosensitizing agent – Type of administration – Dose of photosensitizer – Light dose – Fluence rate – O 2 availability – Time between administration of photosensitizer and light

Conclusions

 Tumor cells show some selectivity for photosensitizing agent uptake  Limited damage to surrounding tissues  Less invasive approach  Outpatient procedure  Various application types  Well accepted cosmetic results

Conclusions:

Clinical Approval of Photosensitizers Nature 2003, 3 , 380.

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Future Applications:

Treatment of Other Diseases Dermatology – Psoriasis, scleroderma, vitiligo Rheumatology – Arthritis Cardiovascular diseases – Artherosclerotic plaque resolution, post-stent implantation Age-related eye diseases – Macular degeneration Immunotherapy Nature 2003, 3 , 380. Photochemistry and Photobiology 2001, 74 , 656.

Future Applications:

Tumor Detection Using Fluorescence   Mechanism by which HpD selectively accumulates in tumor cells – not well understood – High vascular permeability of agents?

Testing photosensitizing agents: – Porphyrins, haematoporphyrins, HpD, ALA-D – Administer photosensitizer and monitor fluorescence with endoscope – SCC shows increased fluorescence – More invasive tumors show even greater fluorescence Nature 2003, 3 , 380.

Future Applications:

Tumor Detection Using Fluorescence   a: Green vascular endothelial cells of a tumor b: Red photosensitizing agent localizes to vascular endothelial cells after intravenous injection Nature 2003, 3 , 380.

Future Applications:

Photosensitizing Drugs   Improved Specificity and Potency – Better photosensitizers developed and under investigation in clinical trials – Use of carriers – conjugated antibodies directed to tumor-associated antigens – New compounds that absorb light of longer wavelength – better tissue penetration – New compounds with less skin photosensitivity Improved Efficacy – Creating a preferred treatment of cancer Nature 2003, 3 , 380.

Thank you