PipelineReview.com - Biotech News & Online Store - Vyteris Announces Positive Results in Two Phase I Clinical Trials for Treatment of Infertility; Data Indicate Actyve(TM) Transdermal Drug Delivery Achieves Therapeutic Levels Of A Peptide Used For Treatment Of Infertility In Humans

Vyteris Announces Positive Results in Two Phase I Clinical Trials for Treatment of Infertility; Data Indicate Actyve(TM) Transdermal Drug Delivery Achieves Therapeutic Levels Of A Peptide Used For Treatment Of Infertility In Humans

11 Aug 2006

Today reported that data from two Phase I clinical trials demonstrated that Vyteris' Actyve(TM) transdermal drug delivery technology delivered potentially therapeutic levels of a peptide, that is used for the treatment of infertility, in humans.

FAIR LAWN, NJ, USA | Aug 10, 2006 | Vyteris Holdings (Nevada), Inc. (OTC BB:VYHN) today reported that data from two Phase I

clinical trials demonstrated that Vyteris' Actyve(TM) transdermal drug delivery technology delivered potentially therapeutic levels of a peptide, that is used for the treatment of infertility, in humans. Vyteris and its partner, Ferring Pharmaceuticals Inc., are in the early stages of developing a product that delivers the peptide for the treatment of female infertility. The development goal is that, through this technology, the peptide could be delivered 24 hours a day in short pulses, to induce ovulation.

In these Phase I clinical trials, a pulsatile profile controlled the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide. The amounts of the peptide delivered were compared with subcutaneous (subQ) and intravenous (IV) infusions of the peptide in humans. The first study, with 45 healthy volunteers, used different formulations within the Vyteris patch that were compared with subQ and IV delivery of the peptide. The plasma concentrations of the peptide demonstrated the feasibility of delivering the peptide in humans using the Actyve(TM) system. In addition, the pulses obtained were sharper and therefore mimicked an IV pulse profile more than a subQ pulse profile. The second study, with 50 healthy volunteers, compared more formulations in the patch and iontophoretic delivery parameters against subQ infusion of the peptide in humans. The plasma profiles of the peptide obtained in the second study achieved potentially therapeutic levels and provided sharper profiles (closer to IV) than subQ profiles. No unexpected adverse side effects were observed in any of the participants in the trials.

The product under development would employ Vyteris' proprietary Actyve(TM) transdermal drug delivery technology, which is positioned to provide a safe and effective method of delivering drugs via a pre-programmed regulating system that mimics the body's natural rhythms, a characteristic important in the delivery of therapeutics for the treatment of infertility. To be effective, medication must be delivered in multiple daily doses for up to 21 days during a female's 28-day cycle. Many patients need to undergo multiple injection based protocols for ovulation induction. The product being co-developed by Vyteris and Ferring has the possibility of administering 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.

The Company's Actyve(TM) transdermal technology uses an integrated circuit to control a small amount of current that delivers drugs through the skin. This process is called iontophoresis. The two-component system employs a transdermal patch containing the drug and a small battery-powered controller that precisely controls the rate and amount of drug released from the patch. The level of control is intended to mimic IV or infusion pump delivery without needles.

Tim McIntyre, chief executive officer of Vyteris commented, "We are encouraged by these Phase I trial results and have accelerated the efforts to develop a novel formulation and controller unit for phase II studies that will commence in the near term. That our delivery system achieved potentially therapeutic levels of the peptide in women and compared favorably to subQ and IV delivery, bodes well for the eventual commercialization of this product. We are very excited and, although it is too early to definitively determine, we anticipate that this technology being developed jointly by Vyteris and Ferring could result in the first non-invasive product that delivers a peptide in a pulsatile manner in order for an infertile woman to bear children."

In September 2004, Vyteris and Ferring entered into a license and development agreement, and a supply agreement to co-develop the Actyve(TM) transdermal drug delivery system to treat female infertility

The U.S. Infertility Opportunity

Infertility affects about 6.1 million women in the United States, or about ten percent of the reproductive-age population, according to the American Society of Reproductive Medicine. According to a 2002 study from Business Communications Company, Inc., the total U.S. market for the treatment of infertility was $2.1 billion in 2001 and is expected to grow to $5.2 billion in 2006. Ovulation disorders are among the most common causes of infertility.

About Vyteris

Vyteris developed the first electronically controlled transdermal delivery system to comfortably deliver drugs through the skin without needles.

This technology offers unparalleled control in the rate, dosage and pattern of therapeutic delivery. The Actyve(TM) platform can be applied to a broad range of pharmaceuticals to provide substantial improvements in therapy for FDA approved drugs that are currently delivered orally, by injection or infusion. Vyteris utilizes its commercialization expertise, proven regulatory, manufacturing and product development capabilities to create high-value therapies in partnerships with major healthcare corporations. For more information visit www.vyteris.com.

Actyve(TM) is a trademark of Vyteris Holdings (Nevada), Inc.

About Ferring Pharmaceuticals Inc

Ferring Pharmaceuticals, part of the Ferring Group, is a privately owned, international pharmaceutical company which markets Bravelle(R), Menopur(R), Repronex(R) and Novarel(TM) in the United States to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information visit www.ferringusa.com.

Forward-Looking Statements

Statements in this press release, including statements concerning our hopes and expectations concerning the product under development, other than historical statements constitute "forward-looking statements". Such forward-looking statements are subject to material risks and uncertainties which could cause the Company's forward-looking statements to be materially inaccurate. The Company has described such risks and uncertainties under the caption "Risk Factors" in various filings made with the SEC, including those contained in the Company's Form 10-Q for the quarter ended March 31, 2006. Other risks and uncertainties include that we cannot assure you that the product under development will be successfully developed, will ever gain FDA or other regulatory approvals, will gain market acceptance, will ultimately provide the benefits that we anticipate, or that we will have adequate financing to complete development.

CONTACT: Vyteris Holdings (Nevada), Inc.
Timothy J. McIntyre, 201-703-2299
www.vyteris.com

SOURCE: Vyteris Holdings (Nevada), Inc.

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