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Market: ASX
Sector: Pharmaceuticals
Epic: SPL
News: Latest news
Web Site: Starpharma
Other Articles: 16-08-201016-08-201015-07-2010

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Starpharma

Starpharma

Starpharma is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications.  The lead pharmaceutical development product is VivaGel®, a vaginal microbicide designed to prevent the transmission of HIV and genital herpes.  Starpharma is developing a VivaGel®-coated condom under a licence agreement with SSL International plc (LSE:SSL), manufacturer of Durex®, the market-leading condom brand worldwide.  Products based on Starpharma’s technology are on the market as diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KgA.  Starpharma is exploring dendrimer opportunities in materials science applications including water remediation and animal health products.

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Thursday, July 15, 2010

Starpharma Holdings receives FDA clearance for VivaGel® study

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Starpharma Holdings (ASX:SPL,OTC:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

Dr Jackie Fairley, chief executive Officer of Starpharma said, "The commencement of our BV program is an important milestone in VivaGel®’s development."

"The treatment and suppression of recurrence of BV opens up a whole new application for the product in an attractive, established market. Feedback we’ve received suggests that a product without the drawbacks of a conventional antibiotics and designed for use during sex, is likely to be very well received indeed.”

VivaGel® is under investigation for both the short term treatment and longer term suppression of recurrence of BV in women. This initial phase of the clinical program will investigate the treatment of BV with a once daily for seven days treatment of VivaGel® and its findings will guide further investigation of suppression of recurrence.

The global market for topical BV treatments alone is estimated at approximately US$350M. The current treatment for BV with conventional antibiotics (orally or topically) is acknowledged to be inadequate by clinicians with high recurrence rates and common side effects.

The study will be conducted under an investigational new drug application (IND) at sites in US and will enroll 132 women. Final preparations are already well advanced and it is expected that the study will commence within a month. The primary objective of the study is to identify the efficacy and optimal dosing for VivaGel® for BV with three strengths (0.5%, 1% and 3%) being compared with a placebo gel. Subjects will be assessed at the end of treatment and then two to three weeks after the end of treatment.

BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodor. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population. The condition is implicated in pelvic inflammatory disease and may also be associated with an increased risk of sexually transmitted infections, including HIV, and pre-term birth.

Current treatments may lead to the development of drug resistance, increased susceptibility to thrush candidiasis), and drug interactions and topical treatments are often incompatible with condoms. Earlier trials of VivaGel® for BV have shown no signs of these issues and VivaGel® is designed to be used with condoms.

VivaGel® is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating in collaboration with SSL International. Other indications are also under assessment, including prevention of human papillomavirus, and other STIs.

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