As these clinical and commercial opportunities in VivaGel® and drug delivery advance towards important inflection points, the solid cash balance positions Starpharma well for creating significant additional value. The above activities are further supported by Starpharma’s strategy in agrochemicals, which provides broader application of Starpharma’s dendrimer technology.
Operating and investing cash outflows were A$4.9 million for the quarter. This expenditure relates to all Starpharma programs, including the two phase 3 clinical trials for VivaGel® R-BV, the phase 1 clinical trial of DEP™ docetaxel, and regulatory activities.
“This quarter has been another period of substantial progress for Starpharma. With two exciting clinical programs underway, a high level of activity with our partnered drug delivery programs, the VivaGel® condom in market and other applications underway, and a strong cash position the company is very well placed to capitalise on,” said Starpharma Chief Executive Officer Dr Jackie Fairley.
SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2015.
DEPTM docetaxel dosage levels exceeds the most commonly used Taxotere® dose
Majority of sites in phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) recruiting participants
Regulatory submissions for VivaGel® Symptomatic Relief of bacterial vaginosis
Continued Australian rollout of VivaGel® condom
Increased activity in partnered drug delivery and agrochemical programs
Solid cash balance of A$34.7 million
During the quarter, activities have progressed across all of Starpharma’s programs for VivaGel®, drug delivery and agrochemicals. These include the two active clinical programs – the two phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) and the phase 1 clinical trial of DEP™ docetaxel. The reported cash balance at 31 March 2015 of A$34.7 million supports these activities.
In drug delivery, the phase 1 clinical trial of DEP™ docetaxel continues to show very encouraging clinical data, with the drug remaining very well-tolerated and no neutropenia or hair loss observed to date with a number of patients having received multiple (up to 6) cycles of DEP™ docetaxel. Approximately 50% of the anticipated number of patients have now been recruited across four Australian sites with dose levels now above the most commonly used dose for Taxotere®, a dose at which a vast majority of patients typically experience neutropenia and hair loss. A number of patients being treated with DEP™ docetaxel have exhibited potential anti-cancer activity, across a range of tumor types. This has been achieved despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP™ docetaxel not yet being reached.
Starpharma Holdings Ltd today released an update to the progress of its phase 1 clinical trial of DEP™ docetaxel for advanced solid cancers. The DEP™ docetaxel dose level now exceeds the most commonly used dose for Taxotere® of 75mg/m2, with no dose limiting toxicities (DLT), including neutropenia, having been observed to date.
Approximately 50% of the anticipated number of patients have been recruited into the study and dosed with DEP™ docetaxel. Several patients have received multiple (up to 6) cycles of DEP™ docetaxel.
Available data show that DEP™ docetaxel has been very well-tolerated, with no observations of neutropenia to date. According to the available product information for Taxotere® (currently marketed docetaxel formulation), neutropenia occurs in virtually all patients given 60mg/m2 to 100mg/m2 of Taxotere®, and the most severe (grade 4) neutropenia occurs in 75% of patients given 60mg/m2 of the product. The clinical data for DEP™ docetaxel are in line with preclinical studies in animals that showed that DEP™ docetaxel eliminated the neutropenia seen with equivalent doses of docetaxel alone whilst enhancing anticancer efficacy.
There have also been no reports in the trial of vomiting or hair loss related to the DEP™ docetaxel treatment. By comparison these events occur in a significant proportion of patients receiving Taxotere® as monotherapy.
In contrast to therapy with Taxotere®, which is formulated in polysorbate-80, a detergent that can cause significant hypersensitivity reactions, patients receiving DEP™ docetaxel therapy do not need to receive pre-treatment with corticosteroids (cortisone) because DEP™ docetaxel is detergent free. Additionally, patients receiving DEP™ docetaxel therapy have not required prophylactic treatment with anti-emetics (to stop nausea/vomiting).
GPDB) announced today that its Board of Directors has approved a plan to purchase back as many as one million shares of its common stock, representing up to 60% of its shares in the public float.
Commenting on the decision, GPDB CEO, Rod Smith stated, "The current price is ridiculously low in light of our recent achievements and expectations for significant growth this year. Given the underlying strength of GPDB business and the recent turbulence in the equity markets, we think our current stock price is undervalued. Therefore, we believe the stock buy-back program is in the best interests of our stockholders."
"Look at it this way," says Smith, "2,000 Health Merchants x 1,000 customers shopping monthly, spending their grocery budget on CLEAN foods...do the math. It doesn't take long to understand why we are going to start buying back our common stock in the public float!"
The Board's decision came at the same time GPDB announces the launch of its national Health Merchant Enrollment Tour to establish 2,000 Health Merchants across the country. Rod Smith and "the Company plans to promote enrollment in 23 cities beginning on May 13th in the greater Salt Lake City area of Utah and continuing through Florida, New York, Massachusetts, South Carolina, Illinois, Texas, Minnesota, Colorado, Arizona, Washington and California. "And back again," Smith adds, "until we achieve our goal before the end of the 2nd quarter."
Smith will be on the road meeting with audiences in each city. Audiences will be comprised of 200-300 alternative health care practitioners, chiropractors, health store owners, farmers market administrators, pharmacists, health and lifestyle bloggers, nutritionists, health coaches, dieticians, personal fitness trainers, social media moms, association directors and non-profit administrators-all of who are potential Health Merchants.
After a fantastic 2014, we are tremendously excited about the opportunities this year and beyond. We are deeply grateful for the continued faith and effort of our extended CytoSorbents family: our patients and their families, the physicians and nurses on the front lines using our therapy, our shareholders, advisors, Board of Directors, distributors, strategic partners, research collaborators, and importantly, our more than 50 dedicated employees and consultants both here and in Berlin, Germany. Together, we can help revolutionize the treatment of deadly inflammation, and help give patients a fighting chance.
Finally, we fondly remember Joseph Rubin (1938-2014), our co-founder and Board Director, whose unwavering faith in the potential of our CytoSorb® technology to help people remains an inspiration to us all.
Dr. Phillip Chan, MD, PhD
Chief Executive Officer
Before I conclude, I should comment on the potential use of CytoSorb® as a rescue therapy for "cytokine release syndrome", or CRS, that can lead to cytokine storm in activated T-cell immunotherapy cancer treatments. This is one of the most promising and exciting areas of cancer research where a patient's own white blood cells (T-cells) are engineered to recognize and kill cancer cells. This is a strategy being pursued by major corporate and university alliances such as Novartis/University of Pennsylvania, Juno Therapeutics/Memorial Sloan Kettering/Fred Hutchinson Cancer Center/Seattle Children's Research Institute, Celgene/Bluebird Bio, Kite Pharma/National Cancer Institute, GlaxoSmithKline/Adaptimmune, Merck KGaA/Intrexon/MD Anderson, and Pfizer/Cellectis. In a number of studies, the use of activated T-cells has led to the "cure" or remission of many refractory leukemias and other cancers. Common to all of these activated T-cell therapies is the potent stimulation of the inflammatory response, leading to an expected extended "flu-like" syndrome in patients, characterized by high levels of cytokines. However, CRS can spiral out of control, despite the use of tocilizumab and other prophylactic measures, leading rapidly to multiple organ failure and often death. CRS is exactly what CytoSorb®was designed to control and we believe that CytoSorb® represents a potentially unique rescue therapy to treat immune overstimulation in T-cell immunotherapy. While we are still in the beginning phases of exploring this new opportunity, CytoSorbents already has several initiatives underway.
Meanwhile, the FDA and Device Sponsor would work together to specify the clinical trial design and "least burdensome" efficacy and safety data needed for early marketing approval, leaving the proof of more stringent efficacy to the post-market period. The end result is that devices that are safe and achieve EAP Designation have an opportunity to get to U.S. approval and commercialization much faster, and with less regulatory risk. We believe this new program could benefit CytoSorbents as CytoSorb® currently targets the treatment of many life-threatening conditions such as sepsis, acute respiratory distress syndrome, severe acute pancreatitis, trauma, and many others that do not have effective treatments. As we move forward with our REFRESH cardiac surgery trial in the U.S., we plan to aggressively pursue this EAP opportunity for critical care applications in parallel, and foster open collaboration with the FDA.
We have started 2015 in the strongest financial and commercial position in our history, well-capitalized with a healthy cash position, no debt, and the highest international awareness and interest in our CytoSorb® therapy that we have ever seen. Although we face some potential challenges such as the weakness in the Euro, the need to strengthen our direct sales force, and the unpredictability of timely country-specific product registrations, we continue to believe that the many potential opportunities for significant future growth greatly outweigh these near-term concerns. As detailed in our April 7, 2015 press release responding to Frequently Asked Questions, we have a clear strategy and plan on how to drive long-term, sustainable growth of our business.
To be clear, the diseases we treat are some of the most complex life-threatening conditions in medicine for which no effective therapies exist, and where the risk of death is still one in every three patients despite the best medical treatment. We have no expectation that CytoSorb® will work every time. But with the collaboration and experience of a growing number of physicians who have collectively performed more than 5,500 human treatments to date, we have made significant progress toward identifying which diseases and patients best respond to CytoSorb® therapy. Centralized data from our recently launched International CytoSorb® Registry and from the more than 50 planned investigator-initiated and company-sponsored studies (a dozen of which are already enrolling patients), will also be invaluable to understanding the full potential of CytoSorb®. We now have the funding and clinical development team to advance our trial agenda more aggressively, particularly in the areas of sepsis and cardiac surgery - our two largest markets.
A significant new opportunity has emerged that may accelerate U.S. approval of CytoSorb® for critical illnesses such as sepsis. The FDA has recently issued new guidance on two related topics: the Expedited Access Pathway (EAP) program and the Balancing of Pre-market and Post-market Data Collection for Devices Subject to Premarket Approval. Together, the EAP and Data Collection programs are designed to facilitate and expedite the U.S. approval of medical devices that treat life-threatening or irreversibly debilitating conditions that have no approved alternative treatments. Similar to "Breakthrough Therapy Designation" for drugs and biologics, devices that achieve EAP Designation would be eligible for more intensive FDA guidance and collaboration with senior managers, and priority review.
Dear Fellow Shareholders and Friends,
By all measures, 2014 was an outstanding year for CytoSorbents, highlighted by many significant achievements. We exceeded our internal forecasts for CytoSorb® sales growth, fueled by broadening physician interest and usage in a growing number of countries. We established or strengthened key strategic partnerships with Fresenius Medical Care, Biocon, and a major global cardiac surgery company, and expanded distribution of CytoSorb® to 29 countries worldwide. These initiatives have the potential to catalyze significant future growth. We also began the clinical trial process needed to bring CytoSorb® home to the U.S., initially for the application of cardiac surgery, and possibly later for other applications. Finally, with the support of our shareholders, we became a NASDAQ-listed company, giving CytoSorbents much broader visibility in the investment community and significantly increasing liquidity for shareholders.
With that said, the most exciting part of this journey has been the growing number of stories of how CytoSorb® has helped, in some way, save the lives of ordinary people like you and me. These patients find themselves in the intensive care unit because of common life-threatening conditions such as sepsis and infection, lung injury, trauma, burn injury, pancreatitis, liver failure, and many others where inflammation plays a potentially deadly role. Left untreated, severe uncontrolled inflammation can lead to multiple organ failure, where patients spiral out of control and become unresponsive to therapy, leaving families and physicians with the difficult prospect of having to potentially withdraw life-support. The fact that CytoSorb® therapy has been used to reduce the "fuel to the fire" of this inflammation and help bring many of these people back from the brink of death is, to me as a physician, nothing short of remarkable.
a whole bunch of 'investors' jumped on the bandwagon and have little or no interest in the big story, just trying to make a few bucks. If I bought in at 14, i would have sold too, but I've been in for a few years now and have no intention of selling till this becomes the google of blood filtration or the apple of the diagnostic/cure future.