12 Jun 2019

BY: admin

News

Comments: No Comments

Stuart Therapeutics, Inc. Announces a Strategic Partnership with Ora, Inc.

STUART, FLORIDA June 12, 2019: Stuart Therapeutics, Inc. (STUART), an innovative pre-clinical ophthalmic therapeutic development company, today announces it has entered into a strategic partnership with Ora®, Inc. (“ORA”), the premier global ophthalmology contract research organization.  ORA is investing in its partnership with STUART by providing CMC program execution, IND preparation, and related strategic consulting services.  STUART expects to commence FDA approved Phase 2 clinical trial testing with Ora’s assistance in mid to late 2020 for its lead drug candidate, ST-100.

ST-100, based on STUART’s proprietary PolyColTM collagen mimetic peptide platform, to which it has exclusive worldwide rights, will initially be developed for treatment of Dry Eye Disease (“DED”).  ST-100’s unique mechanism of action is seen as a significant advance in the therapeutic approach to DED, with the potential to offer rapid symptom relief and healing to the estimated 30 million DED sufferers in the United States alone.  The worldwide market for DED treatment is estimated to be in excess of $7 billion and growing at a CAGR of 7+%.

“We are thrilled to be a part of the ST-100 program.  Supporting our clients to bring life-altering products to market is in our DNA, and has been for over 40 years.  STUART’s ST-100 product profile, with its unique mechanism of action suggests that it is a fast acting and broadly applicable therapy that targets and repairs the damaged collagen present in Dry Eye patients,” said George Ousler, Vice President, Dry Eye at ORA.

In pre-clinical proof of concept in vivo testing, ST-100 demonstrated accelerated repair of the epithelial layer, through binding of ST-100 to damaged sub-epithelial collagen layers.  Complete healing of these tissues and the epithelial layer occurred within approximately 24 hours.  STUART, with ORA’s assistance, recently completed a successful pre-IND meeting in early April, obtaining clear FDA guidance regarding: ST-100’s eligibility to move directly to Phase 2 post IND; and its Phase 2 trial design, including proposed Phase 2 endpoints.

“Ora has exceeded our expectations as a development partner,” said Eric Schlumpf, President & Chief Executive Officer of STUART. “Their deep expertise in ophthalmic therapeutic development, including in particular for us ocular surface indications such as Dry Eye, has been invaluable as we’ve engaged with the FDA, and advanced our program.”

Dry eye continues to be the most common reason for patients in the US to seek treatment from ophthalmologists and optometrists,” said David A. Hollander, MD, MBA, Chief Medical Officer for ORA.  “Dry Eye is a complex multi-factoral disease that continues to represent a significant unmet medical need.  The number of dry eye subjects continues to grow globally and dry eye is being seen in increasingly younger patients. Physicians eagerly await new therapeutic options to address this complex, multifactorial disease.  ST100 has the potential to be one of those options.”

Robert Baratta MD, a practicing ophthalmologist, and STUART’s Chairman and Chief Medical Officer, says “Practitioners like me remain frustrated with the fact we currently have little to offer patients in the effective treatment of this increasingly common malady. We believe Polycol’s extremely rapid relief of symptoms will be well received by patients and their doctors alike.  Stuart Therapeutics is delighted to be focusing on delivering an effective remedy.”

About Stuart Therapeutics, Inc.
Stuart Therapeutics’ mission is to offer unique solutions for difficult-to-treat diseases of the eye. The company is focused on research and development of ophthalmic therapeutic products based on the company’s proprietary PolyCol Collagen Mimetic Peptide platform. The company is developing PolyCol first as a therapeutic for Dry Eye Disease in its initial drug candidate, ST-100, and has several other ophthalmic indications in discovery and pre-clinical stage.

For more information, please visit www.StuartTherapeutics.com.

About Ora®, Inc.
Ora is the world’s leading full-service ophthalmic product development firm with offices in the United States, the United Kingdom, Australia and Japan. Over the past 40 years, we have proudly helped our clients earn 47 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com.

Ora®  is a registered trademark of Ora, Inc.

22 Apr 2019

BY: admin

News

Comments: No Comments

Stuart Therapeutics Announces Positive Retinal Indication in vitro Results for PolyCol

April 22nd, 2019, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc., a pre-clinical stage life sciences company developing solutions for difficult to treat ophthalmic diseases, today announced positive results from in vitro experiments using its proprietary collagen mimetic peptide (CMP), PolyColTM (PolyCol) to probe applicability for conditions associated with dry age-related macular degeneration (Dry AMD).  The experimental results demonstrate that PolyCol:

  • Promotes proliferation, migration and network formation of Retinal Pigment Epithelial (RPE) cells in vitro;
  • Repairs damaged collagen matrix fibers restoring parallel orientation similar to that observed in the matrix of uninjured endogenous tissues;
  • Improves collagen alignment in parallel streams by about threefold compared to vehicle treatment;
  • With documented statistical significance, increases migration and adherence of RPE cells vs. both vehicle and native collagen;
  • Provides a substrate for migration with less impedance than natural collagen;
  • Provides a useful model of the migration and adherence of RPE cells in vivo in areas of collagen damage accompanying retinal pigment epithelial disruption.

Taken together, these in vitro results support the possible use of PolyCol in promoting RPE cell migration, coverage, and repair in a variety of back-of-eye conditions including dry and wet age-related macular degeneration and other eye disorders, diseases, injuries and conditions involving the retinal pigment epithelium.

“An unexplored area of opportunity exists in the treatment of diseases relating to the retinal pigment epithelium,” said Bob Baratta, MD, Stuart’s Chief Medical Officer.  “Stuart tested its proprietary collagen mimetic peptide PolyCol on in vitro models designed to show its potential in retinal indications.  The mechanism of action to be tested is similar to that which the company is developing for ocular surface disease indications, where the rapid repair of the basement membrane and other sub-epithelial tissues encourages effective and rapid recovery of the associated epithelial cells.   Experimental results show promising and significant results for proliferation, migration and network formation of RPE cells.”

Eric Schlumpf, President & CEO of Stuart said, “We are very encouraged by these test results, and they point to a novel way to treat challenging retinal indications.  We are designing in vivo experiments to provide further proof of concept data to support this important opportunity.  Due to the unique mechanism of action of PolyCol, we saw several areas of potential application.  Back of eye indications are particularly troubling, with diseases like dry age related macular degeneration having no available therapy.  PolyCol’s ability to encourage rapid RPE recovery could make a difference for patients.”

 

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

03 Apr 2019

BY: admin

News

Comments: No Comments

Stuart Therapeutics Receives Positive Response in Pre-IND Meeting with FDA for its Dry Eye Disease Therapeutic Candidate, ST-100

April 3rd, 2019, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has successfully completed a pre-IND meeting regarding the development plan for ST-100, Stuart’s first drug candidate for Dry Eye Disease (DED).  The meeting, held with the Food and Drug Administration’s Center for Drug Evaluation and Research, Division of Transplant and Ophthalmology Products, was completed remotely.  FDA provided clear guidance with respect to Stuart’s proposed non- clinical and Chemistry Manufacture and Control (CMC) related programs as well as its clinical trial plans, and concurred with Stuart’s intent to proceed directly to Phase 2 clinical trials after submission of its IND. There were no concerns expressed by the agency with respect to the ST-100 molecule.

Based on the FDA’s positive response to Stuart’s pre-IND filing, the company anticipates filing an IND for ST-100 in mid 2020 and proceeding to initiate Phase 2 testing on DED patients.  The Phase 2 endpoints proposed by Stuart in its pre-IND filing have been deemed acceptable by the agency.

“We are extremely pleased with the results of our discussion with FDA.  We can confirm that the FDA agrees with our clinical development pathway and gave us clear guidance with respect to our overall plans.  Following our meeting with FDA, we can confirm that ST-100 can move from IND filing directly into Phase 2 testing,” said Bob Baratta, MD, Chairman and Chief Medical Officer of Stuart.

ST-100, Stuart’s first drug candidate, is based on its patented Collagen Mimetic Peptide, PolyColTM (PolyCol) ST-100 has demonstrated in pre-clinical animal testing that it provides rapid repair of damaged corneal epithelial and sub-epithelial tissues in the eye, making it an ideal therapeutic candidate for DED and other ocular surface indications.  Based on ST-100’s product profile, it is expected to be an extremely fast acting drop formulation therapeutic that can be complimentary to existing anti-inflammatory treatments.   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 to painful eye surface damage that is a hallmark of DED.  “The result of this meeting is that Stuart can enter the clinic quickly, with minimum risk, consistent with our plans to demonstrate ST-100’s fundamentally new mechanism of action for the treatment of dry eye disease.  This is an important confirmation of our planning and development with our team, partners and advisors.  Stuart has made significant strides in just over a year of operation.  The accomplishment of this milestone underscores the company’s commitment to bringing this exciting new approach to ocular surface disease to the market,” said Eric Schlumpf, President & CEO of Stuart Therapeutics.

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

25 Feb 2019

BY: admin

News

Comments: No Comments

Stuart Therapeutics, Inc. Announces Relationship with Ora, Inc. for IND Preparation, Regulatory Advisory, and Clinical Trial Services for ST-100

STUART, FLORIDA February 25, 2019: Stuart Therapeutics, Inc. (STUART), an innovative pre-clinical therapeutic development company, today announced that it has retained the services of Ora®, Inc., the premier ophthalmology Contract Research Organization (“CRO”) globally, to provide various product development, IND preparation, regulatory advisory and clinical trial services for STUART’s first drug candidate, ST-100.

ST-100 is based on the proprietary PolyColTM collagen mimetic peptide platform, to which STUART has exclusive worldwide rights, and will initially be developed for treatment of dry eye disease (“DED”).  ST-100’s unique mechanism of action, healing damaged collagen in the anterior segment of the eye, is seen as a significant advance in the therapeutic approach to DED, with the potential to offer rapid relief to the estimated 30 million sufferers of this condition in the United States alone.  The worldwide market for DED treatment is estimated to be in excess of $7 billion and growing at a CAGR of 7+%.

In pre-clinical proof of concept testing, ST-100 has demonstrated accelerated repair of the epithelial layer, through binding of ST-100 to exposed sub-epithelial collagen layers.  Complete repair of these tissues and the epithelial layer occurred within approximately 24 hours.  ST-100 is expected to be broadly applicable to the patient population and should have therapeutic applications in patients regardless of the underlying cause of their DED. STUART and ORA will be meeting with the U.S Food and Drug Administration (FDA) for a pre-IND meeting in early April 2019 to confirm IND submittal requirements and Phase II clinical trial design for ST-100.

“Ora was the first partner that we sought out as we began to pursue ST-100 applications in ophthalmology,” said Eric Schlumpf, President & Chief Executive Officer of STUART. “They are the leader in ophthalmology and selecting them as our provider was the right strategic decision for our company.  Dry eye is a difficult indication for physicians and patients due to the long and uncertain treatment cycle associated with current anti-inflammatory approaches to treating the disease.”

“Despite several product approvals and a number of drugs in the development pipeline, Dry Eye Disease remains an ophthalmic disease with significant unmet medical needs. Prescription renewal rates for anti-inflammatory therapies are low, and physicians and patients have limited therapeutic options that deliver rapid relief,” said David A. Hollander, MD, MBA, Chief Medical Officer of Ora. “DED is one of the leading reasons for patient visits to eye care specialists. Novel therapies that treat the signs and symptoms of DED will be welcomed by both dry eye sufferers and physicians.”

“We see ST-100 as an important addition to the arsenal for physicians, who will be able to offer their patients rapid relief and effective repair of ocular surface damage associated with DED” said Robert Baratta, MD, Chairman and Chief Medical Officer of STUART.  “We look forward to working with the Ora team in the development and clinical testing of ST-100 for treating DED, and improving patients’ vision and satisfaction with their treatment.”

“We are pleased to support STUART on the development of ST-100 for the treatment of DED.  Better understanding DED and evaluating novel therapies to treat this prevalent disease has been at the heart of what we do for over twenty years.  ST-100 has the potential to be a broad acting, first line therapy for DED which is exciting for the patients who are counting on us to bring additional therapeutic options to market.” said George Ousler, Ora’s Vice President of Dry Eye.

About STUART
Stuart Therapeutics’ mission is to offer unique solutions for difficult-to-treat diseases of the eye. STUART is focused on the research, development and production of ophthalmic and other therapeutic products based on the company’s proprietary PolyCol Collagen Mimetic Peptide platform. The company is developing PolyCol first as a therapeutic for Dry Eye Disease in its initial drug candidate, ST-100, and has several other ophthalmic indications in discovery and pre-clinical stage.

For more information, please visit www.StuartTherapeutics.com.

About Ora®, Inc.
Ora is the world’s leading full-service ophthalmic product development firm with offices in the United States, the United Kingdom, Australia and Japan. Over the past 40 years, we have proudly helped our clients earn 46 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com.

04 Oct 2018

BY: admin

News

Comments: No Comments

Stuart Therapeutics Announces Corneal Epithelial Healing and Organization Pre-Clinical Results for its Potential Dry Eye Therapeutic

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

17 Sep 2018

BY: admin

News

Comments: No Comments

Stuart Therapeutics Announces Important Pre-Clinical Results for ST-100

September 17th, 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).  Mouse eye wound tests conducted at the University of Louisville demonstrated rapid, high quality healing of corneal wounds, results that support Stuart’s development of PolyCol as a potential therapeutic for dry eye disease (DED) and other ocular surface indications.  The results showed:

  • Statistically significant acceleration of epithelial renewal compared with controls.
  • Statistically significant adherence of epithelium to Bowman’s layer compared with controls. Adherence is similar to unwounded corneas.
  • Complete or near complete reduction of fluorescein staining (used to visually demark the perimeter of the wound and inflammation) within 24 hours.

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 syndrome, 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 demonstrate compelling healing rates for eye wounds and ocular surface damage in a variety of indications. 

 “These results show important and new capabilities that may ultimately relieve a wide variety of painful indications on the surface of the eye, for which there are very few options for physicians,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. “As a result of these tests, we will be accelerating our development of PolyCol first as a dry eye disease therapeutic, followed by other ocular surface indications.”

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

 

12 Sep 2018

BY: admin

News

Comments: No Comments

Stuart Therapeutics has been selected as a semi-finalist in the BioPitch competition at the 21st annual BioFlorida Conference

September 12th, 2018, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has been selected as a semi-finalist in the BioPitch competition at the 21st annual BioFlorida Conference, October 14th – 16th in Ft. Lauderdale, Florida.  The BioPitch competition annually selects 15 companies as semi-finalists that present in front of angel and venture capital investor representatives, with finalists presenting on the final day of the conference.

Stuart Therapeutics presentation will focus on the notable pre-clinical results that the company has generated for its collagen mimetic polypeptide, PolyCol, and its plans for further development and FDA approval as a therapy for dry eye disease and other ocular surface conditions.

PolyCol is a patented polypeptide that mimics human collagen.  PolyCol targets, anchors to and repairs damaged collagen in the body, and can also deliver a chemically linked therapeutic, making it an ideal combination therapy for a variety of clinical conditions.  Stuart is developing its first product, ST-100, as a drop formulation for dry eye syndrome, to heal damage to the ocular surface caused by dry eye, providing rapid relief of signs and symptoms of the indication.  PolyCol is believed to be broadly applicable to the estimated 30 million sufferers of dry eye symptoms in the United States, due to it direct reparative approach to painful damage to the surface of the eye.

“Stuart Therapeutics is please to have been selected to present at the BioPitch competition at BioFlorida,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. “This is a great opportunity to share our results and plans with the broader Florida life sciences community.”

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

 

07 Sep 2018

BY: admin

News

Comments: No Comments

Stuart Therapeutics Selected to Present at the Next Generation Session at BioEurope in November

September 7th, 2018, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has been selected to present as one of a handful of emerging companies at the Next Generation Session during the 24th annual BIO-Europe Conference, November 5 -7, 2018, in Copenhagen, Denmark.  BIO-Europe is the largest life science partnering conference in Europe.

Stuart Therapeutics’ presentation will focus on the notable pre-clinical results that the company has generated for its collagen mimetic polypeptide, PolyCol™, and its plans for further development and FDA approval as a therapy for dry eye disease and other ocular surface conditions.

PolyCol is a patented polypeptide that mimics human collagen.  PolyCol targets, anchors to and repairs damaged collagen in the body, and can also deliver a chemically linked therapeutic, making it an ideal combination therapy for a variety of clinical conditions.  Stuart is developing its first product, ST-100, as a drop formulation for dry eye disease, to repair damage to the ocular surface caused by dry eye, providing rapid relief of signs and symptoms of the indication.  Stuart believes that PolyCol will be broadly applicable to the estimated 30 million sufferers of dry eye disease in the United States, due to its direct reparative approach to painful damage to the surface of the eye.

“Stuart Therapeutics is pleased to have been selected to present at BIO-Europe,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. “We look forward to sharing our compelling results, and actively engaging with potential strategic partners and prospective investors at the conference.”

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 and other applications for this technology.

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.
www.StuartTherapeutics.com
Email: Contact@StuartTherapeutics.com

 

22 Aug 2018

BY: admin

News

Comments: No Comments

Stuart Therapeutics Joins The Jupiter Life Science Initiative

August 22nd, 2018, Stuart, Florida

For Immediate Release

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has joined the Jupiter Life Science Initiative (JLSI) in Jupiter, Florida.  Stuart will establish its research and development laboratory facility there, where the company will conduct a series of pre-clinical development efforts to advance its two platform technologies, PolyColTM (PolyCol), and TheraColTM(TheraCol).

The Jupiter Life Science Initiative’s goals are to enhance education and foster research in the life sciences while fostering research and collaboration with local biotechnology and life science companies.  Leading research institutes, including the Max Planck Florida Institute for Neuroscience and The Scripps Research Institute, are co-located on Florida Atlantic University’s John D. MacArthur Campus.  The proximity of the institutes encourages collaboration of faculty members, students and local life science companies.

PolyCol is a patented synthetic polypeptide that mimics human collagen.  PolyCol targets and heals damaged collagen in the body, and can also deliver a chemically linked therapeutic, making it an ideal combination therapy for a variety of clinical conditions.  Stuart is developing its first product, ST-100, as a drop formulation for dry eye syndrome, to heal damage to conjunctival surfaces caused by dry eye, providing rapid relief of signs and symptoms of the indication.

TheraCol is a patented resorbable device designed to deliver a therapeutic on a controlled basis over an extended time.  The device can be programmed to resorb into the body between one and eight months.  The technology is ideal for clinical indications where sustained and safe delivery of a therapeutic is indicated.  Stuart is developing its second product, ST-101, as a small (2mm X 4mm) insert, an extraocular device as a treatment for glaucoma.  Stuart will be testing various therapeutics in the TheraCol platform, and also certain PolyColTheraCol combinations.

“Stuart Therapeutics is proud to be associated with the Jupiter Life Sciences Institute,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. “Gaining access to the Florida Atlantic University Honors Program, and Scripps Research and Max Planck Institutes’ programs is a significant benefit and accelerator for our development programs.”

About Stuart Therapeutics:

Stuart Therapeutics is a pre-clinical stage pharmaceutical company focused on the development of PolyCol, a collagen mimetic peptide therapeutic platform, and TheraCol, a flexible drug delivery platform.  The company is developing ophthalmologic applications for these technologies.

ST-100 and ST-101 are candidate therapeutics that are in pre-clinical evaluation and that have 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

 

16 May 2018

BY: admin

News

Comments: No Comments

ST-101 Announcement

May 16th, 2018, Stuart, Florida
For Immediate Release
Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has completed the acquisition of the intellectual property rights to a patented bioresorbable drug delivery insert that is designed for both anterior and posterior segment ophthalmic diseases. The technology, designated ST-101 by Stuart, is being evaluated for its ability to treat conditions such as glaucoma, wet age-related macular degeneration, and retinitis. Stuart has negotiated an exclusive license to this technology.
ST-101 is a small wafer that is inserted subconjunctivally and which is being evaluated by Stuart as a means to deliver medication on a sustained basis for up to eight months. This sustained release approach may be ideal for glaucoma patients, as it potentially eliminates the need for patient administered drops, and the proposed eight-month cycle of replacement for the patient matches the typical visit frequency preferred by physicians. Stuart has conducted in vivo testing of the insert in animal studies, which demonstrate the effective delivery of therapeutic levels of latanoprost to the aqueous humor in test animals. The extraocular placement of the insert in these animal studies caused no irritation or scarring.
For posterior conditions such as wet age related macular degeneration, Stuart is evaluating the safety and effectiveness of similar placement of the insert to deliver an anti-VEGF therapeutic over a multi-month period. If safe and effective, the company believes that a key advantage of ST-101 in this indication is that it would potentially avoid the necessity of intraocular injections, making it less invasive than competing alternatives, and improving patient acceptance. The sustained release feature of the insert suggests that reduced frequency of administration may be possible. Stuart has pre-clinical ex vivo data supporting the trans-scleral transmission of medication using this technology.
ST-101 has multiple potential drug delivery applications, and Stuart intends to pursue development of the technology for these additional opportunities.
“ST-101 gives Stuart an important additional tool that may be very useful in the treatment of certain ophthalmic diseases,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. The original TheraCol development work has demonstrated important capabilities that we believe can be readily adapted to both anterior and posterior segment ophthalmic conditions, and potentially improve upon both the current standard of care and several therapies under development. We are pursuing supporting research for the most critical indications, and will seek development partners to further extend the reach of the product.”
About Stuart Therapeutics:
Stuart Therapeutics is a pre-clinical stage pharmaceutical company focused on the development of PolyCol, a synthetic collagen mimetic peptide therapeutic platform, and ST-101, a flexible drug delivery platform. The company is developing ophthalmologic applications for these technologies.
ST-101 is a candidate therapeutic that is in pre-clinical evaluation and that 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

  • 1
  • 2