Pioneering scientific work by the late Dr James Dobbie, established that extra-alveolar lamellar bodies (micron-scale vesicles) manage the internal interfaces between human tissues and also the interfaces between tissues and the external environment as in the mouth and lungs.

Many conditions are associated with thick sticky mucosal surfaces e.g. Radiotherapy Induced Xerostomia (RIX), Dry Eye Disease (DED) and Cystic Fibrosis (CF) which may benefit from the application and biophysical effects of lamellar bodies.

Realising the therapeutic potential, Lamellar developed patented mimetics, Lamellasomes™, of the native extra-alveolar lamellar body replicating the component lipids and their composition. The lead compound, Visco-ease, has a 3D microstructure and biophysical properties essentially identical to those of native lamellar bodies.

 

20150121-fingerprint
An electron micrograph of an extra-alveolar body showing the typical multilamellar aspects. Lamellar bodies are typically 1.5-2.0 microns.

Visco-ease – an attractive cancer supportive care opportunity

  • Indication: Radiotherapy Induced Xerostomia in Head and Neck Cancer.
    • Significant, growing market.
    • Acute and chronic treatment opportunity.
    • No competition in sight.

Clinical Efficacy Study:

  • A 2-arm, randomized, double blind study comparing 19.6mg/ml against placebo for the 6 week RT treatment.
  • Duration of Study: 9 months involving 35 adult patients – Results H2 2016.
  • Primary Objective: Assess subjective efficacy of Visco-ease versus placebo in abating RIX using the GRIX questionnaire.
    • Demonstrate the benefits of “muco-restoration”
  • Chief study investigator: Dr Claire Paterson, Beatson West of Scotland Cancer Center.

Regulatory Status and Timelines:

  • CE Mark: Submitted for approval.
  • Clinical trial start – April 2016.
  • Clinical data – Q2 2016.
  • Commercial CE mark – H2 2015 or H2 2016.
  • FDA 510(k) application submitted using predicate route: Potential Approval Q1/2-2016.
  • IP: Granted EU-28, Australia, New Zealand, Canada and US (pending for Dry Mouth).

 

Key Visco-ease Summary:

  • Presentation: Final Format, Multi-Dose, Medical Device to full cGMP.
  • Safety and tolerability: full data set.
  • Clinical: Full Efficacy Data anticipated H2/2016.
  • Regulatory: Full CE Mark anticipated H2/2016.
  • US FDA 510(k): Potential Approval Q1/2016.
  • IP: 2023 – 2026 (excluding SPCs).

Lamellar is looking for a partner to commercialise this exciting cancer supportive care product.