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Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced the commencement of its phase 2 study of VivaGel® for the treatment of bacterial vaginosis (BV), following receipt of ethics approval.
Starpharma announced in July 2010 that the US Food and Drug Administration (FDA) had accepted and cleared its investigational new drug application (IND) for the study. Clinical trial sites in the US will be initiated this week and will commence enrolment of participants immediately.
This 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 its use in both treatment and suppression of recurrence.
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.
Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "The commencement of this study is an important step in the development of VivaGel®. Experts in this field have indicated there is a desperate need for new treatment options for BV."
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.
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma's business, which can be identified by the use of forward-looking terminology such as "promising", "plans", "anticipated", "will", "project", "believe", "forecast", "expected", "estimated", "targeting", "aiming", "set to", "potential", "seeking to", "goal", "could provide", "intends", "is being developed", "could be", "on track", or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer technology for pharmaceutical, life-science and otherapplications. SPL has two operating companies, Starpharma Pty Ltd inMelbourne, Australia and DNT, Inc in the USA. Products based on SPL’s dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KgA.
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