 View 2010 |
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 Greetings!
Welcome to MacuCLEAR's FAll View 2010! It has been almost a year since our last issue....and what a year 2010 has been!! MacuCLEAR started 2010 with an acquisition offer of considerable value, and as a blessing in disguise, rejected it in September. Our last "View" mentioned the results of our novel, and successful, Phase Ib/POC human clinical trial. This past May, these clinical results were presented in a peer-reviewed poster session at the 2010 ARVO meeting in Ft. Lauderdale, Florida. We achieved additional patent protection on our intellectual property, and made progress on our US filing. Much of our effort this year has been focused on designing a next phase clinical program that we believe will yield true clinical efficacy data. We have gained considerable traction for our lead drug, MC-1101, from several leading institutions and individuals devoted to finding a treatment for dry AMD. We were invited to and participated in the First Biennial AMD Symposium, and attended the American Association of Ophthalmology meeting. We have secured sufficient new funds to meet the Texas Emerging Technology Fund's Qualifying Funding Transaction requirement, and have engaged professional sources to help us raise necessary funds for our clinical program. Finally, we have made some necessary changes in our board of directors which prepares MacuCLEAR for its next level of growth. Each of these accomplishments are detailed in respective sections in this newsletter.
We are proud of our progress to date, and we appreciate the encouragement and support we get from you, our stakeholders and the patients with AMD who hope for the ultimate clinical success of MacuCLEAR's portfolio of products. We invite any comments, suggestions or questions, at any time.
Sincerely,
Phil Ralston
President and CEO
MacuCLEAR, Inc
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MacuCLEAR rejects HOTI acquisition
As a result of Healthcare of Today Inc.'s ("HOTI") failure to meet the terms of the Purchase Agreement entered into March 10, 2010. the representatives of the former members of the Board of Directors of MacuCLEAR, pursuant to the Power of Attorney granted by the former shareholders of MacuCLEAR, have rescinded the Purchase Agreement, effective September 17, 2010. As a result of the rescission all transactions set forth in the Agreement are reversed and of no further impact on MacuCLEAR. Management and the former Board Members attempted to work with HOTI and its representatives to reach an agreement on modifications to the Purchase Agreement that would be mutually beneficial to HOTI and the former shareholders of MacuCLEAR. Unfortunately we were unable to reach an agreement. HOTI offered alternatives such as a reverse merger into a public shell to be followed by a secondary public offering. These alternatives were a substantial departure from the original agreement, would result in additional delay in the payment of the promissory notes of at least 18 months and uncertainty as to the future registration of the HOTI stock. Such terms were unacceptable. We can have a Phase II study near completion in that time frame, with a much larger payoff possible with a Big Pharma partnership. The next steps are to return to each MacuCLEAR shareholder their stock certificate and to return to HOTI the Promissory Notes and stock certificates that were issued to the former shareholders. We are disappointed HOTI was unable to fulfill its obligations; however, we have continued to move the Company forward. We are making progress on initiating the Phase II clinical trial and expect to begin recruiting study participants Q1/2 2011. At least 16 Big Pharma companies remain in contact with us in anticipation of our Phase II results. We are pursuing financing alternatives to meet our funding requirements.
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ARVO Poster Presentation
MacuCLEAR submitted an abstract to the Association for Research and Vision (ARVO), summarizing the results of our successful Phase Ib/POC human clinical trial. After peer review our poster presentation was selected to be displayed at the annual ARVO meeting this past May, in Ft. Lauderdale, Florida. The presentation generated considerable interest amongst the clinicians, researchers and industry personnel attending the meeting. The poster conclusion states:" these results demonstrate that with repeated dosing with MC-1101 ophthalmic solution is safe and well-tolerated. Ocular hyperemia, which was the most commonly reported AE, was expected given MC-1101's mechanism of action. The choroidal blood flow results suggest that MC-1101 may reach the back of the eye and the macular area to improve choroidal blood circulation following topical ocular instillation. Since impaired blood flow may be a contributing factor in the progression of dry AMD, these study results suggest that MC-1101 may be a useful therapeutic agent for the treatment of dry AMD and the potential multifunctional benefits of MC-1101 to subjects with dry AMD should be further explored."
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Intellectual Property/Preclinical Progress
Patent Counsel advises MacuCLEAR's Intellectual Property has received a patent in Australia. Another patent issuance has been cleared in Canada. Final office action appears to be imminent in the US Patent Office on one of three pending patents, specifically the claims pertaining to MC-1101.
Our lead compound, MC-1101 is a repurposed compound, one that has 505 b 2 eligibility with FDA. This important designation allows MacuCLEAR the ability to cite the safety and toxicology of the original use of this compound, which has saved the Company approximately 2 years of time and approximately $2 million in testing costs. The FDA likes to work with companies with these types of compounds because the development and clearance risks are less than new chemical entities. In addition to saving time, money, and possibly exclusivity, the FDA is willing to provide early feedback as the compound moves through clinical development. Our decision to start with MC-1101 was based on our desire to get a quality drug through IND and into clinical trials as quickly as possible.
Notwithstanding the advantages of 505 b 2 drugs, MacuCLEAR's license with Texas A&M University includes at least 10 other compounds aimed at disorders of the eye that are all new chemical entities. These drugs include second generation treatments for AMD. One compound, MC-2201 in development in Dr. Chiou's laboratory, not only appears to treat dry AMD, it also appears to have properties that will treat Diabetic Macular Edema, another serious vision disorder, and a huge market. We are evaluating what is needed to move this compound through appropriate pre-clinical work so that we can file a second IND as soon as possible.
MacuCLEAR is planning on bolstering its IP with filings on its unique formulations of its portfolio compounds, as well as certain patents covering its drugs packaged in novel delivery systems.
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 Clinical Trial Progress
One of the challenges MacuCLEAR faces as it moves MC-1101 through the clinical process is how to design a trial that will meet its endpoints at the end of the trial. It has been Company policy to not initiate another study, with sufficient funding or not, until a viable study design and chances of a fair outcome, good or bad are established. It is critical to our success with the several potential strategic partners that are eager to see our efficacy data that we have valid study data that meets our primary endpoints.
Dry AMD clinical trials have heretofore been considered difficult because this disease can progress very slowly, and definitive endpoints for proving a drug has had an affect on the progression of the disease have been elusive. No competitive drug for dry AMD has been approved to date, and none have successfully gone beyond a Phase II clinical trial. At least two companies have gone out of business after failing to meet their endpoints.
MacuCLEAR has been consulting with several notable clinicians and researchers to develop a study design that will avoid the mistakes made by others. One advantage of MC-1101's method of treating the disease is its vascular model. All other companies addressing dry AMD are treating one of the many natural metabolic pathways that generate waste products in the retina. Since there are many, no one company has been able to stop the waste products that occur in the retina and end up affecting a critical blood barrier, the Bruch's Membrane that separates the tissues of the retina from the blood flow that supplies it. Dr. Chiou postulated that aging causes a reduction of blood flow in these capillaries. This compromised blood flow allows waste buildup to occur that allows a breakdown of the Bruch's Membrane. Once ruptured, new blood vessels, stimulated by the reduction of blood flow, now can get through the Bruch's Membrane into the retina, break down, bleed and cause the "wet" form of AMD.
In the past few weeks, MacuCLEAR and its scientific advisiors have identified a novel study design that it believes will achieve its clinical objectives. Once this clinical design is approved by its scientific team, a protocol will be finalized and a Special Protocol Assessment (SPA) will be requested with the FDA. We hope to schedule the SPA before the end of the year.
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Professional Meeting Participation
ARVO proved to be a valuable meeting as a considerable number of clinicians, researchers and industry personnel took interest in MacuCLEAR's novel clinical results during its poster presentation.
MacuCLEAR was invited to participate in the First Biennial Symposium on AMD, sponsored by Massachusetts Eye and Ear, held at the Schepens Eye Center at Harvard Medical School, in Boston, September 30-October 2, 2010. One of the sessions of this 2 day event focused on Choroidal Blood Flow, the Bruch's Membrane and Retinal Pigment Epithelial cells, the basic targets of MacuCLEA R's novel mechanism of action for treating dry AMD. The keynote speakers of this session supported a vascular model for addressing this disease. This was a useful event to meet many of the luminaries working in the field of AMD. Several have expressed interest in MacuCLEAR and follow up conversations are in the works.
MacuCLEAR also attended the annual American Academy of Ophthalmology, held in Chicago, October 16-19. This was another opportunity to review the competitive landscape and network with colleagues,  clinicians and industry leaders. The Retinal Specialties subsection confirmed there are no competitors ahead of MacuCLEAR.
There are several new diagnostic tools such as an instrument to effectively evaluate dark adaptation, our ability to adjust from a bright room into a dark room, that appears to be a common factor in AMD patients. Increasing sensitivity of imaging equipment is improving the ability of doctors to see visual disorders sooner and to track progress...or hopefully...the lack thereof of disease. MacuCLEAR is discussing the use of some of these new tools in its clinical program.
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Funding Status
MacuCLEAR has approximately $1 Million available to continue current operations. It is going to take an estimated total of $10 Million to complete the next phase of its clinical program over the next 2.5 years. This is clearly a considerable sum and a challenge to raise in our current economy, yet the payoff will be significant with successful efficacy data. One of our potential strategic partn ers suggested "it will be easier to write you a $ Billion check with good data than even a $ 10 Million check today." This may have been just hyperbole, however, another company in this space, one of those which is pursuing one of those metabolic pathways mentioned above, (and likely to fail) has nonetheless secured a partnership deal involving an upfront license payment, and milestone payments in excess of $263 Million. MacuCLEAR has always been a clear binary investment. If it doesn't work it is an out. If it does work, and our pre-clinical and human clinical work to date strongly suggests it will, it is not going to be a home run, it is going to be a grand slam home run!
One who passionately believes in MacuCLEAR, almost as much as Dr. Chiou and me, is Fred Cole. Fred lives in Harlingen, Texas, and is a devoted Texas A&M Aggie. He read about MacuCLEAR in a Texas Aggie magazine, talked to his brother who is a practicing ophthalmologist, and ended up buying up the last of our Series A stock last summer. He offered to help us raise the money for our clinical trial, but then the HOTI deal came along. Undaunted, Fred stayed faithful to MacuCLEAR, and when HOTI was rejected, Fred stepped up with a renewed commitment to raise money for our clinical program. Fred knew our immediate need was to raise a minimum of $500K of new money to meet a Texas Emerging Technology Fund qualifying financial transaction (QFT) requirement. Fred introduced MacuCLEAR and its opportunity, to several of his colleagues. The result was nearly $700K at the new price of $12.00 per share. This QFT set the price at which Texas gets its warrants for its earlier investment of $1.7 Million. The new price per share results in nearly 200,000 shares less dilution to our shareholders. Fred is committed to raising another $1-1.5M by the end of the year. He is reaching out to all he knows and to our current shareholders for help in meeting his self-imposed goal. Knowing how hard he drives himself, we are confident he will make it happen.
We have other funding efforts underway as well. We are pleased to be working with some professional firms with key contacts with Venture Capitalists, Institutional Investors, and Family Offices. We have a novel funding option with the College of Medicine Foundation at Texas A&M. High net worth individuals looking for a tax deduction, or foundations needing to make mandated donations can use this method. The donated funds can be properly directed ultimately to MacuCLEAR to manage its clinical program.
Finally, we continue to pursue a strategic
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partnership. Since ARVO, we have been in discussions with several potential partners, and in at least one, second level talks are in the works. Doug Baum is doing a fine job of headingup our efforts to secure the right partner.
We are encouraged with our technology progress and the reasons it is gaining traction with those seeking a solution to the terrible problem of AMD. We are confident we will raise the funds necessary to prove Dr. Chiou's work will once again successfully solve a serious vision problem.
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Brett Cornwell Joins Board of Directors
Bre tt Cornwell is the Associate Vice Chancellor for Commercialization at The Texas A&M University System, and becomes the Texas A&M representative on the board of directors. He directs the Office of Technology Commercialization and is responsible for the New Ventures Division which spins out new companies in support of the commercialization of technologies from the Texas A&M University System. The services for new spin out companies include screening stage market assessments, business plan development, marketing plan development, market research studies, strategic business planning, and the development of venture pitches. Brett Cornwell is a Faculty member at IC2 Institute at The University of Texas at Austin and is an Adjunct Professor in the McCombs School at the University of Texas at Austin as an instructor in the Master's in Science and Technology Commercialization degree program. He is also on the adjunct graduate faculty at Texas A&M University teaching courses in technology commercialization in the Mays Business School. His courses focus on technology market screening and evaluation, venture planning and evaluation, and business planning and launch. He has led a number of international technology commercialization benchmarking and training projects including projects with CONACYT in Mexico, South Australian Water Researchers in Australia, The University of Otago in New Zealand, and ProTon in Europe. Brett Cornwell was a program coordinator for the NASA Mid-Continent Technology Transfer Center (MCTTC) for ten years and served as the deputy director for three. At MCTTC, his experience and knowledge was used to write marketing studies for new technologies, outreach to companies, and define market opportunities and barriers for potential licensees. He has eighteen years experience in technology transfer and two years experience with small companies as sales and marketing manager. He was recognized as the Outstanding Technology Transfer Intermediary in Arkansas in 1997, received the Distinguished Service Award from the Mid-Continent Federal Laboratory Consortium in 2001, designed major portions of the Federal Laboratory Consortium's Technology Assessment process for the RIB-IT program and has been published in R&D Enterprise, Asia Pacific. He is the co-author of Marketing Scientific Results published in October 2004. Cornwell holds an MBA from Texas A&M University and a BBA in marketing from Baylor University. Brett replaces Guy Diedrich, as a director. Guy resigned from Texas A&M this past June to pursue other interests. Guy was the founding chairman of MacuCLEAR. He was instrumental in helping to guide the Company through its formal organization and two potential acquisitions. We wish him well in his future endeavors.
Dennis McWilliams, CEO, of Apollo Endosurgical, Inc., in Austin, Texas resigned from MacuCLEAR's board of directors, in order to make room for a new money representative soon to be named. Dennis served as MacuCLEAR's founding outside director, and as a result of his experience as a life science entrepreneur and venture capitalist made several key contributions as MacuCLEAR progressed through its early development. We wish Dennis all the best as he continues to succeed in growing his company.
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MacuCLEAR Receives Government Grant
MacuCLEAR received a grant from the United States (US) Government totaling nearly $245.000.00. This grant came from a one time IRS/HHS program focused on qualifying therapeutic development projects. This is a no-strings attached, non-dilutive sum of money that went to projects that are developing a therapeutic need for an unmet medical need. We are excited that the reviewers recognize the potential value that our platform technology may offer to people who face blindness from AMD. The funds will help accelerate preparation of our clinical program, as well as pre-clinical work towards a second IND.   |
Dr. Chiou to deliver Keynote Address
Dr. George Chiou, MacuCLEAR's co-founder and inventor of the company's platform technology, is well known for his role in leading the discovery of Timolol, the pioneering treatment for glaucoma. In December, Dr. Chiou will be attending the Asian Pacific Joint Glaucoma Congress in, Taipei, Taiwan, where he will deliver a keynote address.... not on Glaucoma, but on his work in treating dry AMD! The title of his talk is "Pharmacological Treatment of Dry AMD". This is quite an honor, and a clear recognition of Dr. Chiou's current pioneering approach to treating the early stage of this leading cause of blindness for people over 50 throughout the world. We wish him well with his presentation and safe travels.
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 Special Thanks to our Stakeholders and our Scientific Team
We have many people to thank for helping MacuCLEAR achieve its current level of progress. We have been very capital efficient in getting to a clinical efficacy stage because of the support of our stakeholders. Our shareholders have provided the critical funding that has fueled our novel clinical program to date. Our suppliers, accounting, legal and industry partners have been responsive, fair, and devoted to our program.
A special thanks is extended to our clinical advisors who have offered important counsel and direction in our development program to date, and the novel design of our next phase of proving clinical efficacy. David Birch, Yizhong Wang, Firas Rahhal, David Faber, Robert Marc, Greg Jones, Paul Bernstein, Deborah Harrison, Gil Feke, Mark Abelson, Avner Ingeman, Ira Wallace, John Edwards, Paul Yates, Steve Rose, Tim Schoen, and SK McGarvey have been generous with their time, expertise and support of our program. We want everyone to know that we appreciate them and all they have done for MacuCLEAR.
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If you have comments or questions about any of the above, please don't hesitate to contact us at:
Phil Ralston
MacuCLEAR, Inc
2300 McDermott Road
Plano, Texas 75025
[email protected]
214 577 5999 | |
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