Vyteris, Inc. (OTC BB: VYTR), manufacturer of the first FDA-approved active patch transdermal drug delivery system, in partnership with Ferring Pharmaceuticals, announced the completion of a Phase I dose ranging study using VyterisÂ™ patented Smart Patch transdermal system for delivery of a peptide hormone. The effective completion of this study is a key ingredient in the preparation work for Phase II studies.
This study demonstrates the potential for delivering peptide molecules into the human body in therapeutic levels without the use of needles, said Haro Hartounian, president of Vyteris, Inc. The dose ranging study is another milestone for us in developing an effective peptide transdermal delivery product.
The dose ranging study represents an important step in the clinical development of a product for female fertility treatment. The results from this study will be used to establish the multiple dose levels of the proposed peptide for a Phase II study.
About the Study
In the Phase I dose ranging study, four different electronic profiles were used to control the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide. By varying the electronic profile from the Smart Patch, the amount of peptide delivered was adjusted above and below the typical therapeutic levels based on subcutaneous (SC) and intravenous (IV) injections. No adverse side effects were observed in any of the trial participants.
The product under development by would employ VyterisÂ™ patented Smart Patch drug delivery technology. The patch is designed to provide a safe and effective method of delivering drugs via a pre-programmed regulating system, a characteristic important in the delivery of therapeutics for the treatment of female infertility. The patch is also designed to administer the peptide without needles and is being designed to deliver multiple transdermal pulses automatically, around the clock in a painless, convenient and cost-effective manner.
About Vyteris, Inc.
Vyteris, Inc. is the maker of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). VyterisÂ™ proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that may result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration. For more information, please visit our website at www.vyteris.com.
This press release includes forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as expect, estimate, project, anticipate, intend, plan, may, will, could, would, should, believes, and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, statements concerning the potential impact of the new marketing agreement and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others, the competitive environment and competitive responses to the new marketing arrangement. The Company has described other important risks and uncertainties under the caption “Risk Factors” in its most recent Annual Report on Form 10-KSB and in various filings made with the SEC. Actual results may differ materially from those contained in the forward-looking statements in this press release.
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The Lee Strategy Group, Inc.
James Lee, 310-229-5771
For Ferring Pharmaceuticals:
Andrea Preston, 203-762-8833