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36 nanotimes Companies Facts
S tarpharma Holdings Ltd (ASX:SPL, OTCQX: SPHRY) reported excellent progress in the recruitment for its pivotal Phase 3 trials for VivaGel(R) as a treatment for bacterial vaginosis (BV). Two concurrent Phase 3 trials are underway and recruitment for these trials, which commenced in late March 2012, has recently passed the halfway mark with 60% of patients already enrolled. One of the trials has already exceeded 80% enrolment. The Phase 3 treatment trials are taking place across more than 30 international sites, primarily in the United States. Following the completion of the Phase 3 trials Starpharma expects to prepare and submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in parallel with engaging in licensing negotiations. The FDA has already provided formal agreement as part of a Special Protocol Assessment (SPA) declaring that the phase 3 trials' design, clinical endpoints and statistical analyses are acceptable for FDA approval once completed. "We are extremely pleased with the rate of enrolment for the pivotal Phase 3 trials underway. We are already approaching two thirds enrolment in less than three months, which means we are well on track to complete and report the trials in 2012 as indicated," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
The market for topical treatments of BV is estimated at US$300-$350 million. Moreover, Starpharma Holdings reported that recruit-ment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel(R) to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel(R) for the treatment of BV. The primary objective of the study is to determine the efficacy of two strengths of VivaGel(R) (containing 1% or 3% SPL7013) compared with a placebo gel in preventing recurrence of BV. The product is used every second day over a period of 16 weeks. Starpharma also provided an update on the developments within its substantial drug delivery program. Starpharma’s program to enhance the blockbuster cancer drug docetaxel is advancing rapidly and plans are underway for clinical trials to commence in 2013. Starpharma has also demonstrated its dendrimer technology’s applicability to hormones such as insulin, and antibodies, further diversifying drug delivery product potential into these high-growth segments of the market. In addition, Starpharma continues to expand its partnered delivery programs with major pharmaceutical companies’ proprietary drugs.
Tegal Corporation (NASDAQ:TGAL) announced financial results for the fourth quarter and fiscal year 2012, which ended March 31, 2012. The Company’s net (loss) per share decreased to ($0.85) for the year from a comparable ($1.85) from the prior fiscal year. The Company ended the fiscal year with $7.8 million in cash, an increase over the prior year of approximately $0.2 million. This balance reflects the use of cash for the investment in NanoVibronix and proceeds of the IP asset sale. Tegal and its portfolio companies achieved numerous milestones in Fiscal Year 2012. Tegal’s two portfolio companies are Sequel Power, a private company dedicated to the development and operation of large scale photovoltaic (PV)-based solar utility projects. Tegal made a $300,000 strategic investment in Nano-Vibronix Inc., a medical device company focused on creating products utilizing its proprietary low-intensity surface acoustic wave (SAW) technology. The company‘s unique, patented approach enables the transmission of low-frequency, low-intensity ultrasound waves through a variety of soft, flexible materials, including skin and tissue, enabling low-cost, breakthrough devices targeted at large, high-growth markets. Moreover, Tegal has signed a definitive agreement to acquire CollabRx, Inc., a privately held technology company in the rapidly growing market of interpretive content and data analytics for genomics-based medicine.