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cets of applied sciences, and engineering. The engineers, clinicians, tems and terminology ineering, and showcases nanotechnology. It is an e University Sydney by for Presentation an introduction to the

Day 2 - 7 February AINST Bioimaging in nanotherapeutics Chair: Dipesh Khanal (USyd, Australia)

9.30-10:20

Prof Peter LAY (USyd)

Bio-nano-spectroscopy information purposes only. All rights reserved. For more information please contact Sean Hall +61 411603378, or [email protected]

10:20-11:10

Dr Elizabeth NEW (USyd)

Who Am I? • CEO and founder of Medlab Clinical Limited (ASX:MDC). • Co-authored on multiple patents, publications, an active member of Medicines Australia, AusBiotech, American Federation of Medical Research (AFMR), The American Academy of Anti-Ageing Medicine (A4M), World Medical Association (WMA), Special Operations Medical Association (SOMA), and a Board Member of the International Probiotics Association (IPA).

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Presentation for information purposes only. All rights reserved. For more information please contact Sean Hall +61 411603378, or [email protected]

Who Are Medlab? Medlab Clinical (MDC) is a medical research and development facility researching and formulating novel therapeutics to improve health outcomes in early to moderate stage chronic diseases such as chronic kidney disease and pre-diabetes/obesity. Medlab Clinical: •

Is an ASX listed company - 14 July 2015

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Has been granted Cannabis licence - 29 July 2015

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An OGTR accredited facility as PC2 laboratory

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Has an Institutional BioSafety Committee accredited with the OGTR


Medlab’s Focus – Chronic Diseases CANCER

Over the past 3 decades, survival rates for cancer have gradually increased. 861,057 Australians were alive in 2009 who had been diagnosed with cancer in the previous 28 years.

CHRONIC KIDNEY DISEASE

1 in 10 Australians aged 18+ (10%) had biomedical signs of CKD in 2011–12, with the majority of these showing early signs of the disease.

DIABETES

1 in 19 Australians (5.4%) had diabetes in 2011–12 (self–reported and measured data). This is includes approximately 1% of the population who did not self-report they had diabetes, which may indicate they were unaware they had the condition.

MENTAL HEALTH

The most recent data shows that mental health conditions are highly prevalent in the population. In 2007, 1 in 5 Australians aged 16–85 (20%) experienced a mental disorder in the previous 12 months. In 2013–14, 1 in 7 children aged 4–17 (14%) were assessed as having mental health disorders in the previous 12 months.

MUSCULOSKELETAL CONDITIONS

Over 1 in 4 Australians (28%) reported having arthritis and other musculoskeletal conditions in 2011–12. The most prevalent conditions were back problems, osteoarthritis, osteoporosis and rheumatoid arthritis. o Extracted from: http://www.aihw.gov.au/chronic-diseases/.

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NanoCelle™ - from Medlab…What is it? •

NanoCelle™ is designed to avoid the body’s natural metabolic pathways (digestion) by allowing API absorption via non traditional routes of administration e.g., oro-buccal membrane.

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Controlled lowered therapeutic dosage means less administered API.

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Reduced side effects compared against standard therapy.

Now… Water soluble Dispersed particles

NanoCelle™ betacarotene in water

Oil Based betacarotene over water

Medlab’s Answer - NanoCelle™


NanoCelle™ - What is it? 1.Nano-sized particles consisting of a fat-soluble core (drug/nutrient) and a watersoluble outer layer. 2. Particle Size: NanoCelle™ particle size ranging from 0.038 to 0.9 micron, comparative to a red blood cell of approximately 7-8 micron in size. 3. Routes of administration include oro-buccal, intra-nasal, topical and subcutaneous injection. 4. Reduced dosage of the API, with similar clinical efficacy to standard therapy, significant reduction in known side effects. 5. Decomposition (oxidation/loss of viability) protection for API. 6. Nanocelle™ API can be adsorbed on a carrier protein, bacteria and potentially virus.


Particle Sizes – NanoCelle™ Particle

Particle Size (nm)

Concentration

Particle Lab Validation

12.85

2 mg/mL

Particle Technology Labs

11.41

10 mg/mL


89.31

0.1 mg/mL


14.62

1.67 mg/mL


14.37

1.67 mg/mL


12.71

10 mg/mL


16.43 10.6

1 mg/mL 4 mg/mL

Particle Technology Labs University of Sydney

13.17 3.843

2.6 mg/mL 15 IU/mL

Particle Technology Labs Particle Technology Labs

12.7

7 mg/mL


15.48

2 mg/mL


12.19

5 mg/mL


Sertraline Hydrochloride (2162016SER)-SSRI

15.21

0.5 mg/mL


Testosterone Propionate (1232015TES)-hormones

14.31

15 mg/mL


Ampicillin Sodium Salt (2162016AMP)-antibiotics Atorvasatatin (1022015ATO) Atorvastatin (1232015ATO) Atorvastatin-25 (12142015ATO25) Atorvastatin-30 (12142015ATO30) Atorvastation (2162016ATO) Beta-Estradiol (2162016EST)-hormones Fexofenadine (Telfast) Dexamethasone (2162016DEX)-hormones Insulin (1022015INS) Perindopril Erbumine (2162016PER)-ACEi Progestogen (2162016PRO)-hormones Rosuvastatin (1022015ROS)-statin


NanoCelle™ particle size distribution An exemplar…

NanoCelle™ Examples

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(Nanabis™) Cannabis

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(NanoStat™) Atorvastatin


Nanabis™ PATENT PENDING


Nanabis™ - The Problem… The Problem • Opioid abuse and addiction is clinically evident • Opioid safety and toxicity levels are real concerns in advanced cancer pain • Risk of Opioid induced coma is real The Opportunity: Develop a new narcotic that can be used as an adjuvant therapy to standard therapy in advanced cancer pain. Allowing for the diminished ongoing use of opioids, reducing ongoing patient risk, whilst providing effective pain management.


NanoCelle™ Cannabis (Nanabis™)

Stakeholder research à Pre-clinical trial àRNS Clinical trial à Health Canada à HREC Concentrated 80% Extracts Plant

NanoCelled CBD/THC Cleaned 80% Extract

Proposed Product


NanoCelle™ Cannabis (Nanabis™) Medlab's pathway is to develop a new Schedule 8 pharmaceutical that can be used alongside or in place of both oxycodone and morphine sulfate. The uniqueness of Nanabis™, will be the tiny (sub-micron) particle size, available via spray to the buccal membrane (side of mouth), allowing rapid absorption and release of the medicine, superior to most other delivery platforms eg tablet, capsules and other sprays/liquids. 2 sprays of Nanabis™ will deliver of active cannabis (2.4mg CBD and 2.6mg THC) to the patient. Anticipated 6 month completion of trial


NanoStat™ PATENT PENDING


NanoStat™ - The Problem… The Problem • Statins are overprescribed • Approximately 1/3 of patients report pain associated with statin use • New legislation supports daily dosage of low dosage Statins to everyone over 55 as a preventative, as well as standard therapeutic dosages for anyone overweight or at risk of any CVD The Opportunity: Develop a low dose but more efficacious statin product without the majority of carriers, excipients and fillers, that provides the same clinical outcome with a reduction in reported side effects.


10mg Atorvastatin ≈ Chemical Composition


NanoCelle™ Atorvastatin (NanoStat™) Research outcomes • Fast absorption < 1 minute • Performs as expected to Atorvastatin • This strongly indicates, superior absorption and utilisation by the body with speed and accuracy. • Nanostat™ work is now moving into bioequivalent studies to compare NanoStat™ to regular Atorvastatin (Lipitor)


So…..

You do all this work, you’re invested in your innovation, so what…

Why The Need For Innovation? • Progresses discovery • Adds potential commercial value • Potentiates patent work • Solves/addresses problems


What Is The Problem?

The key question to innovation – WHAT IS THE PROBLEM TO BE SOLVED?


Examples, Problem Solving •

Making cars more environmentally friendly.

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Making data more available to the consumer.

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Making medicines safer.

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Making medicines more convenient and easier to use.

Why Delivery Platforms? •

Reduced dosage

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Less side effects reported by patients

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Convenience


What About Delivery Platforms •

Dosage à The effect on the curve, what does safety look like?


Examples From Medlab •

CBD/THC

Public and Political desire – NEW HORIZON Opioid side effects

Overuse •

Statins

Dosage escalation Side effects e.g. Myalgia Our focus today is on delivery platforms


Innovation To Partnership •

Going commercial is tough

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Do you go it on your own or or do you enter into a form of partnership? Both have pro’s & con’s

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More importantly, when do you make this decision?


If There Is A Partnership… •

How do you agree milestones (fiscal, discovery, regulatory, etc)?

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What do the “go to market” timelines look like?

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What is the ”risk” to the commercial entity in this discovery going to market?

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What “creepbacks” are you comfortable with?


What Type of Partnership? •

Trade sale – the outright sale of the discovery and all IP surrounding the discovery

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Licensing/royalty Agreements - whereby you receive a % of sales or outright fee at a specified frequency, based on a pre-defined scope, e.g. 5% of all sales in Australia for 5 years paid monthly.

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Developmental Agreements – both parties mutually agree milestones and subsequent payments for milestones, usually around discovery, patent approvals and regulatory approvals – designed to eventually become one of the above 2 points.


Next Step – Nanabis™ •

Awaiting HREC approval for Phase 1 dose escalation tolerability, safety & efficacy trial.

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At successful completion, work with TGA for Special Access Scheme (SAS) approval.

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Whilst under SAS continue trial work.

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Commercialise with interested trade partner – several under NDA presently.


Next Step – NanoStat™

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Conduct Pilot BE programme.

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Commercialise with interested trade partner – several under NDA at present.

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Refine product to trade partner’s interest


Think Endpoint, First •

Problem identification allows us to better conceive the innovation and its intended use.

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This then allows us to review the marketplace and/or literature to eliminate the "blue-sky"

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We are now articulate the innovation, its need, use and start to conceptualise its commercial value.

Research Team Medlab Clinical Ltd and The University of Sydney, Sydney Medical School Prof Luis Vitetta Prof Anthony Linnane Prof Robert Allen Dr Elizabeth Steels PHD scholars Talia Palacios Michael Thomsen Dr Giselle Cooke Emma Saltzman Medlab Clinical Ltd Sean Hall Dr Rachel Manuel Dr Joyce Zhou Dr Mark Donohoe Tessa Nikov Dr Andrea Leong Isabelle Ibrahim Medlab Clinical, California U.S.A Dr David Rutolo

The University of Sydney, Sydney Medical School Prof Stephen Clarke Prof Andrew McLachlan The University of Queensland, School of Medicine Dr Matthew Bambling Dr Paul Masci Dr Kong Nan Zhou A/Prof Glenda Gobe Dr David Briskey The University of Queensland AIBN Prof Matt Trau The University of New South Wales, School of Medicine A/Prof Jeremy Henson Southern Cross University Prof Graham King WriteSource Medical Dr Belinda Butcher


Thank You

Medlab Clinical Limited ASX: MDC Phone: 02 8188 0311

www.medlab.co www.facebook.com/MedlabAUS
