Alec McLean Presentation

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Focus on Industry, NHS & Academia

Dr Alec McLean

Lamellar Biomedical

Lamellar Biomedical:

 Is a semi-virtual R&D biotech SME based in Bellshill,

Glasgow.

 Has developed a lead compound, LMS-611, which is a mimetic of a natural lamellar body.

 Is developing new medical devices and pharmacological products based on LMS-611.

 Has extensive research links with the NHS and academia, including clinical studies, research programs and PhD studentships, principally with

Scottish institutions.

Lamellar Biomedical’s Mission

Lamellar Biomedical’s mission is to research, develop and commercialise novel healthcare products based on the mimicry or modification of the lamellar body secretory system.

Lamellar bodies……

 Maintain the properties of mucosal tissues e.g. surface tension, moisture loss and lubrication.

 Manage the interface between tissues and the external environment as in the mouth and lungs.

 Have biophysical not pharmacological properties.

 Are NOT alveolar surfactant in form, location or function.

Lamellar Bodies & LMS-611

Lamellar bodies in upper airways

EM of a human lamellar body with tightly packed concentric rings

Lamellar’s mimetic lamellar body (LMS-611) with similar 3D microstructure & properties.

Confocal micrograph of LMS-611

The Therapeutic Targets

1. Radiotherapy Induced Xerostomia

(Dry mouth)

3. Cystic Fibrosis

2. Dry Eye Disease

Clinical Collaborators

• Clinic: Beatson West of Scotland Cancer Clinic.

• Facilities: Phase 1 Cancer CTU.

• Staff: Dr Claire Paterson, Maureen Thompson and Barry Caldwell

• Clinic: Glasgow Caledonian University Vision

Sciences.

• Facilities: Specialist regional ophthalmology centre and GGCHB Phase 1 unit.

• Staff: Drs Iain Pearce, Nail Strang & Louise

Madden.

• Clinics: UK CF specialist centre: West of

Scotland CF Unit.

• Facilities: Bespoke CF clinic with Phase 1 capabilities.

• Staff: Drs Bicknell, McGregor and McCartney

(West of Scotland).

West of Scotland CF Unit Logo

Clinical Collaborators: Rationale

• Globally, 685,000 new cases of Head and Neck Cancer (HNC) every year.

• ~80% of HNC cases develop Radiotherapy -Induced Xerostomia (RIX) .

• RIX is the “most significant long-term complication of radiotherapy in

the head and neck region

• DED is the most common condition seen by eye care practitioners.

• In the USA ~8 million have moderate to severe DED.

• Patients with moderate to severe DED have a quality of life, comparable to those with moderate to severe angina.

• DED is growing rapidly worldwide.

• CF is the most common fatal genetic disorder in the Caucasian population.

• Around 80,000 people worldwide have CF.

• CF is still under diagnosed.

• At present, CF is incurable.

Clinical Collaborators: Rationale

• “there is no strong evidence that any topical therapy is effective for

relieving the sensation of dry mouth”.

• Excluding Kepivance (6% of cases), there are no effective treatments (RIX- Beatson Cancer Clinicians).

• Inflammation and oral infection are also common consequences of

HNC radiotherapy.

• “a broad spectrum of formulations is available as artificial tears and ocular lubricants. Most products, however, offer only

symptomatic and short-term relief”.

• Patients are susceptible to chronic inflammation and eye infections.

• Patients experience repeat unresolved infections, chronic inflammation and bacteria develop resistance to antibiotics.

• Treatments aim to treat the consequences of the disease with the exception of Kalydeco which only treats around 3-5% of patients.

• Average survival age of around 40 years.

Lamellar Perceived Benefits

• Regulatory

– Co-sponsored study.

– Protocol Input (clinical relevance).

– Early introduction to the ethical/regulatory process (CTEC).

– Study covered by NHS Indemnity and Insurance.

• Resource

– Access to GGCHB Phase 1 clinical trials unit (skills, cost)

– Access to GGCHB vendor relationships e.g. Robertson Centre for

Biostatistics

– Coverage of Greater Glasgow academic units e.g. Glasgow Caledonian

University.

• Research Facilities e.g.

– Preclinical ex-vivo study in RIX at the Beatson.

– Access to specialised equipment, staff and samples.

Lamellar Perceived Challenges:

• Co-sponsored status

– protocol input: clinical v commercial aspects (low).

• Contracting

– NHS time lines are longer than commercial CROs (medium).

• Project Management

– Input required from Lamellar for internal GGCHB functions (medium).

• Access to Staff

– Clinical/academic vs Lamellar priorities (low to medium).

• Publication rights

– Commercial vs Academic interests (low).

• IP rights

– Need to be addressed - ownership and commercial licensing (Medium)

Progress & Outcomes to date..

RIX Dry Mouth

• Successful 30 patient ex vivo study in patients with

Head & Neck (H&N) cancer undergoing radiotherapy.

• Presentation of results at:

– International Conference on Innovative Approaches in H&N

Oncology.

– 3rd European Society for Radiotherapy & Oncology forum.

– Multinational Association of Supportive Care in Cancer.

• Published in “Supportive Care in Cancer”.

• At CE Device audit for clinical trial authorisation.

• Clinical study in H&N cancer submitted for approval.

Progress & Outcomes to date..

Dry Eye

 Fully funded PhD program with GCU covering:

• Filamentary Keratitis;

• Sjogrens Syndrome;

• Environmental Induced Dry Eye;

• Contact Lens Compatibility.

 Product at CE Device audit for market authorisation.

 Full clinical study with GCU in Dry Eye going to submission.

Progress & Outcomes to date..

Cystic Fibrosis

 Lamellar funded medical PhD into form, function and frequency of lamellar bodies in

CF.

 Successful SE SMART grant of £430 to support pre-clinical CF research program.

 Clinical study with West of Scotland CF unit going to submission.

Q & As

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