04 Oct 2018

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October 4th, 2018, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced important pre-clinical in vivo proof of concept results for its collagen mimetic polypeptide therapeutic, PolyColTM (PolyCol).  The company announced additional important results from its mouse eye wound tests.  Previous results showed statistically significant results for both acceleration of epithelial cell growth and adherence to Bowman’s layer compared with controls, indicating rapid high-quality healing of corneal wounds.  In the company’s latest results, high resolution histological examination was conducted on both the wounded and the adjacent unwounded portion of mouse eyes, with samples taken 24 hours after wounding.  Eyes were treated with PolyCol drop solution and compared with controls.  Epithelial cell nuclei were quantified over a fixed area to determine the deviation from the segment average.  The results showed:

  • Statistically significant reduction in variability of epithelial cells in the wounded portion of the eye as compared to negative controls, with results analogous to what was seen in the unwounded portion for eyes treated with PolyCol.
  • PolyCol appears to promote regularity in the epithelial layer by reducing the variability in the number of cells.
  • Epithelial layer nuclei count and distribution in the wounded portion of the eye were similar to that of the unwounded portion.
  • These results are further support for PolyCol as a rapid healing agent for damage ocular surface, and a promising therapeutic for signs and symptoms of dry eye disease.

PolyCol has demonstrated in several ex vivo and in vivo tests that it targets, anchors to, and repairs damaged collagen.  This behavior is particularly important in ophthalmology, given the significant presence of collagen in the stroma of the eye and adjacent tissues. Stuart is developing its first PolyCol product, ST-100, as a drop formulation for dry eye disease, to heal damage to the ocular surface caused by dry eye, providing rapid relief of signs and symptoms of the indication.  Stuart believes that ST-100 should be broadly applicable to the estimated 30 million sufferers of dry eye symptoms in the United States, due to the direct reparative approach of PolyCol to painful damage to the surface of the eye.

The recent in vivo tests were conducted by creating a consistent wound covering over 70% of the exposed portion of the mouse eye.  The mice were then treated with PolyCol, or with positive or negative control solutions.  The eyes were collected at sacrifice and histologically examined at high magnification for epithelial recovery, adherence of the epithelium to Bowman’s layer, and stromal recovery and healing.

These results appear to support the conclusion that administration of PolyCol may result in compelling healing rates for eye wounds and ocular surface damage in a variety of indications. 

 “These new results support our development of PolyCol as a dry eye disease therapeutic, and the potential for relief for a wide variety of painful indications on the surface of the eye,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc.

About Stuart Therapeutics:

Stuart Therapeutics is a pre-clinical stage pharmaceutical company focused on the development of PolyCol, a collagen mimetic peptide therapeutic platform.  The company is developing ophthalmologic applications for this technology and others.

ST-100 is a candidate therapeutic that is in pre-clinical evaluation and has not been approved by the U.S. Food and Drug Administration (FDA) for use in treating, preventing, curing or diagnosing any disease or disorder.  Similarly, the statements contained in this Announcement have not been evaluated by the FDA, and may be considered “forward-looking statements” under applicable securities laws.  Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.  Although forward-looking statements contained in this presentation are based upon what management of Stuart Therapeutics believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Stuart Therapeutics undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contact:
Stuart Therapeutics, Inc.
StuartTherapeutics.com
Email: Contact@StuartTherapeutics.com

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