FAIR LAWN, NJ--(Marketwire - August 10, 2010) - Vyteris, Inc. (OTCBB: VYTR), developer of the first FDA-approved active transdermal patch and a leader in alternative drug delivery technology, today announced positive results from a Phase II clinical trial evaluating the safety and efficacy of a pulsatile delivery system for the treatment of female infertility, based on the Company's smart patch technology.
The Phase II trial enrolled 350 women between 18 and 38 years of age with ovulatory dysfunction. The trial assessed the safety and efficacy of three dosage strengths of pulsatile gonadotropin releasing hormone (GnRH) delivered from an iontophoretic patch compared to oral treatment with another leading infertility drug, and placebo. Based on the Company's evaluation of the data, the trial met its primary endpoint by demonstrating a statistically significant difference in ovulation rates for the pulsatile GnRH versus placebo over the single, 21-day treatment cycle. Furthermore, among treatment-compliant patients who had at least one progesterone assessment on or after one week of dosing, the pulsatile GnRH achieved ovulation rates similar to the other leading infertility drug, which is considered a first line treatment option for a majority of these patients. The most common adverse event in the trial was skin irritation at the site of administration.
GnRH is a naturally occurring hormone that is currently approved by the U.S. Food and Drug Administration to induce ovulation in patients with hypothalamic amenorrhea, which is relatively rare and affects three to five percent of the women with ovulatory dysfunction.(1) The present study indicates GnRH may also be used to safely and effectively induce ovulation in patients with other forms of anovulatory infertility, who represent a wider segment of the infertility population. Furthermore, GnRH historically has not been associated with the antiestrogenic side effects observed with the leading oral infertility treatment used in the comparator arm of the study.
The limitation of currently commercially available GnRH-based treatment is its method of delivery, which requires that the patient use an infusion pump over prolonged periods of time. Based on results of this Phase II trial, Vyteris' active, transdermal smart patch technology may provide a convenient, non-invasive means of administering pulsatile GnRH.
"The positive outcome of our Phase II trial in female infertility represents a significant milestone for Vyteris and a promising development for the women worldwide who suffer from infertility," said Michael Reidy, Ph.D., Chief Technology Officer at Vyteris. "These data underscore the potential of Vyteris' smart patch technology to meet the growing demand for controlled drug delivery in major therapeutic areas."
According to Family Planning International, approximately 10 percent of all couples worldwide have or have had fertility problems. The World Health Organization estimates that there are approximately 60-80 million cases of infertility around the world. Infertility affects about 7.3 million women and their partners in the U.S. -- about 12% of the reproductive-age population.(2)
About Vyteris, Inc.
Vyteris, Inc. is the maker of the first active, ready-to-use drug delivery patch (LidoSite®) to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris' proprietary active transdermal smart patch technology delivers drugs comfortably through the skin using low-level electrical energy (iontophoresis). This smart 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. Vyteris has successfully delivered a peptide non-invasively using its system, where the company demonstrated achievement of therapeutic levels of a peptide without using any needles. For more information, please visit us at www.vyteris.com.
(1) 4. Pettersson F, Fries H, Nillius SJ. Epidemiology of secondary amenorrhea. I. Incidence and prevalence rates. Am. J. Obstet. Gynecol. 1973; 117: 80-6
(2) Fertility, Family Planning, and Reproductive Health of U.S. Women: Data from the 2002 National Survey of Family Growth.
Vyteris Forward-Looking Statements
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-K 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.