Research and Development
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Clinical investigators supported by ProCertus are performing a series of five Phase I and Phase I/II clinical studies designed to demonstrate the safety and efficacy of the DermX, ProDermaCel and OralX product formulations in normal subjects and cancer patients.
- August, 2011 – Dr. Nik Rao at the H. Lee Moffitt Cancer Center (Tampa, FL) begins patient enrollment in a Phase I/II clinical trial to determine the safety and efficacy in radiation alopecia prevention of topically applied ProDermaCel vasoconstrictor in post-surgical head and neck patients receiving cranial radiotherapy. More Information
- February, 2011 - Dr. James Cleary and Dr. George Cannon at the University of Wisconsin Carbone Cancer Center begin patient enrollment in a Phase I/II clinical trial to determine the safety and efficacy in radiodermatitis prevention of topically applied DermX vasoconstrictor in post-surgical breast cancer patients receiving 50-60 Gy radiotherapy course to prevent cancer recurrence. More Information
- February, 2011 - Second Phase I study is completed. DermX applied to patients receiving radiotherapy to treat bone metastasis demonstrated: i) no blood pressure elevations or significant adverse events, ii) no significant topical or systemic toxicities, and iii) successful compliance with the topical drug application schedule.
- May, 2008 - First Phase I study is completed. Normal subjects receiving six week topical application of DermX formulation demonstrated: i) no significant topical or systemic toxicities over the six week drug course at any of the scheduled doses, ii) successful compliance with the topical drug application schedule that involved five applications per week x six weeks, and iii) successful induction of the scored skin endpoint that predicted complete radioprotection in animal models of radiodermatitis.
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Completed proof of concept studies in animal models for its lead candidates for DermX, ProDermaCel and OralX.
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Developed and optimized proprietary topical delivery formulations for ProDermaCel, DermX and OralX.
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U.S. patent 7,314,959 issued. New family of aminothiols protects against the lethal effects of whole body irradiation; ProCertus is pursuing military and homeland security applications for this family of compounds.
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Pending patent applications to protect the commercial use of its ProDermaCel, DermX and OralX products.
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Funding
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Received $1.77 million in a 2011 round of equity financing led by Novartis Venture Fund, Venture Investors, LLC and the Wisconsin Alumni Research Foundation. |
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Raised $1.05 million in an April 2009 round of equity financing led by Venture Investors and Novartis Venture Fund. |
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Received $2.3 million in a March 2007 round of equity financing led by Venture Investors. Novartis Venture Fund and the Wisconsin Alumni Research Foundation also participated in this and previous rounds of equity financing.
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Received a $1.3 million Phase II SBIR grant from the National Cancer Institute and two Phase I Small Business Innovation Research (SBIR) grants from the National Institutes of Health.
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Received three rounds of loans and grants from the Wisconsin Department of Commerce totaling $550,000.
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Raised approximately $9.0 million in total funding to date.
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Management/Advisors
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Established a management team to lead the Company through the pharmaceutical product development and corporate partnering phases of the Company's life cycle.
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Established a Board of Directors with members who have extensive experience in pharmaceutical development.
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Established a Scientific Advisory Board comprised of experts in oncology and pharmaceutical product development.
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Patents/Trademarks
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United States Patent & Trademark Office indicates that patent covering the inventive technology in the ProCertus DermX, ProDermaCel and OralX development-stage products will issue soon.
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Obtained exclusive worldwide licenses to those patents that cover the ProCertus product portfolio. Patents represent a technology partnership with Wisconsin Alumni Research Foundation (www.WARF.org).
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U.S. Patent 7,314,959, “Aminothiol Compounds and Compositions for Use in Conjunction with Cancer Therapy,” issued in January, 2008.
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Registered trademarks for "ProCertus BioPharm©" and "Technologies that Protect©."
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