Starpharma today announced that following a submission to AusIndustry, it is eligible to receive an additional estimated A$2.3 million cash in R&D tax incentive for overseas R&D activities for its Dendrimer-Docetaxel program.
Starpharma will also receive the 45% R&D tax incentive for eligible Australian expenditure for the Dendrimer-Docetaxel program, including the clinical trial that will commence shortly. The AusIndustry submission supports the clinical and regulatory activities over a three year period beginning in the 2012/13 financial year.
This advance finding is separate from the previously announced substantial overseas tax incentive for the VivaGel® bacterial vaginosis program under the R&D Tax program.
It is anticipated that following lodgement of the company’s 2012/13 tax return, a $4.7 million cash refund will be received in the current financial year.
Starpharma CEO Dr Jackie Fairley said: “The R&D tax incentive is an important program to support Australian companies developing new pharmaceuticals and this positive ruling for Docetaxel is timely as this product moves into the clinic.”
SAN DIEGO, Jan. 7, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that the Company's Chairman and Chief Executive Officer, Jim Joyce, will present at The Biotech Showcase™ 2014 conference on Tuesday, January 14th, at 4:30PM PST. Mr. Joyce's presentation will include an update on a forthcoming FDA-cleared study of the Aethlon Hemopurifier®, a review of U.S. government contract programs, and a progress report on Exosome Sciences, Inc., a diagnostic subsidiary recently launched by the Company.
A live webcast of Mr. Joyce's Biotech Showcase presentation can be accessed
The Biotech Showcase™ 2014 Conference will take place January 13-15, 2014 at the Parc 55 Wyndham San Francisco Union Square Hotel, California. The Biotech Showcase™ is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH),) announced today that the Company will present at two upcoming investor conferences in January: the Biotech Showcase 2014 in San Francisco and the Noble Financial Capital Markets Tenth Annual Equity Conference in South Florida.
Frank Oakes, Stellar’s President and CEO will present at both conferences, providing an overview of the Company, its programs and milestones, and 2014 corporate objectives. Members of Stellar’s executive team will be available for meetings at both events.
Biotech Showcase™ 2014
Date and Time: January 14, 2014, 4:00 PM PST
Venue Location: Parc 55 Wyndham San Francisco, CA
Noble Financial Capital Markets Tenth Annual Equity Conference
Date and Time: January 21, 2014, 8:00 AM EST
Venue Location: Club Med Sandpiper Bay, Sandpiper Bay, Florida
Prepare for transition to major U.S. stock exchange
Frank Oakes, Stellar’s President and CEO said, “We are entering 2014 with unmatched competency in sustainable KLH manufacturing and focused on leveraging this position into new opportunities with key stakeholders and commercial partners in the biopharma industry. We have built high barriers around Stellar’s technology platform, and we are now aggressively expanding with our own immunotherapy development program, further broadening our business potential. This combination of robust platform together with multiple avenues for strategic growth, positions Stellar to capture significant market interest in the future.”
To view the Company’s Fiscal 2013 consolidated financial statements, related notes and Management Discussion & Analysis as well as all of Stellar Biotechnologies’ past reports and filings please visit the Canadian Securities Administrators' website
In October 2013, the Company announced presentation of positive results from a preclinical study related to the C. diff development program.
Environmental Achievements & Intellectual Property: In 2013, Stellar announced several milestones further strengthening the Company’s competitive position and barriers to entry around its KLH business. Among these achievements was the industry-first capability to support the complete life cycle of the Giant Keyhole Limpet (Megathura crenulata), the scarce marine mollusk that is the only source for KLH protein. Stellar also announced new patents issued (in U.S. and China) related to its C. diff immunotherapy technology, as well as two U.S. patent applications for new KLH innovations developed at Stellar.
Stellar’s strategic objectives for 2014 are:
Expand our Stellar KLH™ technology portfolio through ongoing research and development and selective acquisition, while maintaining a strong balance sheet with careful resource management.
Seize opportunities for commercial growth that build on our strengths and core competencies in KLH development and immunotherapy.
Identify strategic pathways that leverage our Stellar KLH™ products and expertise into immunotherapy solutions.
PORT HUENEME, CA, (January 2, 2013) -- Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), announced today the filing of its annual report for the fiscal year ended August 31, 2013 and financial results and operational highlights for 2013.
SELECTED HIGHLIGHTS FROM 2013
New Corporate Partnership: Stellar executed a collaboration agreement with Amaran Biotechnology, Inc. in December 2013, to develop and evaluate methods for the manufacture of OBI-822 active immunotherapy using Stellar’s GMP grade KLH. OBI-822 is the lead immunotherapy product of OBI Pharma, Inc., manufactured by Amaran and currently in Phase II/III clinical trials in the U.S., Taiwan, South Korea, India and Hong Kong, for the treatment of metastatic breast cancer. The collaboration involves an important, multinational clinical project with long-term product development and commercial potential.
Strengthened Balance Sheet: In September 2013, Stellar raised US $12 Million in gross proceeds in a private financing that included a US $5 Million investment by Amaran Biotechnology, Inc., a privately-held Taiwan biopharmaceuticals manufacturer. Proceeds will be used for product research, aquaculture and KLH production development, capital expenditures and working capital. The financing represented continued support from Stellar’s major shareholders, validation from industry investment, and fiscal strength for the Company to execute on its strategic plans
Strategic Program Expansion; Clostridium difficile Active Immunotherapy Platform: In July 2013, Stellar acquired the exclusive, worldwide license to patented technology for the development of human immunotherapies against Clostridium difficile infection (“C. diff”) from the University of Guelph in Canada. The license broadens Stellar’s business opportunities by adding a strong platform for the Company’s own proprietary active immunotherapy program.
Exosome Sciences lead product is ELLSA, an acronym for an Enzyme Linked Lectin Specific Assay, which has been confirmed to identify the presence of exosomes in not only the aforementioned cancer lines, but also human immunodeficiency virus and tuberculosis. The company is working to build-out the platform for additional assays using exosomes as a real-time biomarker for viral infections, pregnancy complications, birth defects and cardiovascular and neurodegenerative diseases.
Paralleling other agreements in the industry, Aethlon intends to sell or license its technology to an established research diagnostics organization. Given the advanced stages of the flagship product and the extensive industry reach that is now afforded to Aethlon with Dr. Taylor joining the team in September, investors should remain attentive to developments on that front.
It has only been in the last few years that the scientific community has started rallying around the use of exosomes. With added attention comes additional possibilities and these companies cumulatively sit at the forefront of exosome research and initiatives within the scope of public entities. Popular Science recently looked ahead at 2014 and named work with exosomes to make cancer diagnoses less invasive as one of the 20 breakthroughs that will shape the world next year.
If industry professionals are seeing the potential of exosomes and major biotechs and diagnostic tool makers are seeing it as well, it’s just a matter of time before Wall Street embraces it, providing a boon in value as they look to get a piece of companies with leadership positions in the space.
Article by Fred Zucker
Exosomes, whether increased in numbers due to a disease or not, do not define a condition, so it is necessary to see what is inside or to be able to test the surface of the exosome to detect a disease. To simplify and understand, think of plastic eggs (exosomes) floating down a river (body fluid). More eggs may indicate that there is a problem, but no matter what, it is necessary to net the eggs for examination and to open them up to interpret what is inside.
It’s this one-two punch of detecting and capturing exosomes that has created a very unique dynamic between Aethlon and its subsidiary Exosome Sciences. Built upon its ADAPT System, Aethlon has developed the Hemopurifier, a first-in-class medical device that has been documented to safely capture pathogens and exosomes in the circulatory system that underlie a variety of conditions and diseases, including colorectal cancer, lymphoma, melanoma, ovarian and breast cancer. Exosome Sciences is developing diagnostic tools with industry-leading sensitivity to detect and quantify the presence of exosomes in body fluids.
The company’s scientific team is led by Dr. Douglas Taylor, one of the world’s foremost experts in exosomes and the man credited with the discovery of tumor-secreted exosomes. Dr. Taylor was pioneering research in exosomes in the 1970’s, long before the U.S. National Institute of Health acknowledged studies of scientists such as Dr. Taylor validating that exosomes are far more than simply cellular debris.
The way that companies are quickly teaming-up to expedite development of technologies related to exosomes exemplifies the unique potential of these tiny, nucleic acid and protein-carrying sacs to revolutionize diagnostic procedures with greater efficiency and less invasiveness than biopsies that are conducted today. It also speaks to the best way to play stocks in the exosome industry: be in early and look for partnerships and cutting-edge developments.
Life Technologies is a leader in utilizing exosomes in diagnostics and a great resource for learning more about exosomes in general. The company has developed technologies for breaking down the process of capturing and isolating exosomes from body fluids and then subsequently isolating and analyzing the proteins or ribonucleic acid that they are carrying. The company sells a broad range of reagents and kits for total exosome isolation, whether from cell culture media, serum, plasma, urine or other body fluids. They also sell kits for isolating specific subpopulations, intact exosome analysis and cargo isolation and analysis.
Life Technologies is in the midst of being acquired by Thermo Fisher Scientific (NYSE:TMO) as part of a $13.6 billion-dollar deal (plus assumption of $2.2 billion in debt) announced in April. Thermo is facing a few regulatory hurdles with buying Life because the combined company will control about half of the cell culture market, which could mean some divestures to gain regulatory approval. However, if the deal is completed, Life will bring a high-profit revenue stream to Thermo through its e-commerce channels that generate a significant portion of Life’s revenue.
Investors who aren’t catching wind of the power of exosomes are missing a rapidly growing science as it relates to diagnostics, drug delivery, and novel disease treatments. Exosomes, nano-size extracellular vesicles secreted by nearly all somatic cells and found in body fluids, were grossly misunderstood historically, but that is all changing. A growing body of research is detailing the relevance of exosomes in cellular health and the important function that they serve in cellular communication by ferrying proteins and genetic materials between cells.
James McCullough, chief executive at privately held Exosome Diagnostics, appropriately has dubbed exosomes as “the body’s Federal Express system.” Perhaps more succinctly, Dr. Douglas Taylor of Exosome Sciences, a subsidiary of Aethlon Medical (OTCBB:AEMD), has said that exosomes are akin to the “Twitter of cells” because of the messages they deliver from cell to cell.
Exosome Diagnostics is developing biofluid-based molecular diagnostic tests for use in personalized medicine, with their lead product being a test that captures exosomes in urine for analysis of ribonucleic acid to detect mutations as an indication of prostate cancer.
A select few public companies have emerged as pioneers in the exosome space, including Life Technologies (NASDAQ:LIFE), Aethlon Medical, and Eli Lilly & Co. (NYSE:LLY). By itself, Eli Lilly is not really a player in the space, but it forged a partnership with Exosome Diagnostics in September to gain access to the company’s diagnostic tests to identify gene mutations and exosome expression levels in the blood that might help them better predict drug response and disease recurrence.
Another way to try and benefit from Exosome Diagnostics’ test kit advancements is to take a look at QIAGEN N.V. (NASDAQ:QGEN) as the two companies partnered in July to develop and commercialize products for capturing and processing RNA and DNA from biofluid exosomes and other microvesicles. The companies hope to have co-branded kits commercialized in the first half of 2014.
Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents, stated, "We are pleased that 24-hour treatment with CytoSorb® has been safe and easy to implement to date, and that it demonstrates robust continuous cytokine removal across the entire treatment period as expected. We are also encouraged that the first arm of the Dosing study has already treated more patients than in the reported data from the EST, and that we are seeing similar trends in a very heterogenous, critically ill patient population. This first arm of the trial has generated many interesting insights that will help to modify the second arm of the trial."
Dr. Chan continued, "Our understanding of how to use CytoSorb® to treat severe sepsis and septic shock, and other critical illnesses continues to advance. This dosing study, nearly 30 post-market investigator initiated studies either starting or being planned, multiple case report studies, and the establishment of an international treatment registry, are part of a much larger plan to generate a significant amount of clinical data in coming months to years that will help physicians optimally treat their patients with CytoSorb®."
CytoSorb® is concentration dependent and continues to actively remove IL-6 during the entire 24-hour treatment period, higher at the beginning of treatment when IL-6 levels are highest, and with an overall average instantaneous IL-6 reduction of 8% per pass. For each patient, approximately 60-70 total blood volumes, the equivalent of approximately 300 liters or 75 gallons of blood, are treated per day. In an in vitro blood perfusion system with no cytokine production, this equates to a rapid and greater than 99% reduction of IL-6. In the body, however, with active ongoing cytokine production, the overall reduction is less.
Safety data obtained from this study on continuous 24-hour treatment will be used to provide additional examples in the "Instructions for Use" document that accompanies the product for commercial usage. This will provide additional flexibility in how physicians use CytoSorb® in sepsis and other critical care applications.
The first treatment arm continues to enroll patients. In this preliminary analysis, the overall 28-day all-cause mortality and 28-day all-cause mortality in patients 65 years and older is statistically similar to the treatment data reported in the EST (electronic randomized cohort). Severity of illness in the overall treatment groups were comparably high, with 50% or more of the treated patients (dosing EST) having an APACHE 2 severity of illness score 25 at the time of enrollment, predicting very high mortality of 55% or more. In comparison, the overall control patients reported in the EST (electronic randomization cohort) had a lower severity of illness with only 20% having an APACHE 2 score 25.
Cytokine analysis and matched pairs analysis is currently ongoing, and 60-day mortality data is still pending on many recently enrolled patients.
There are two CytoSorb® treatment protocols being evaluated in the Dosing study: 1) 24 hours per day for 7 days and 2) 6 hours per day for up to 14 days, each day using a new device. Currently, only the 24-hour treatment arm is enrolling patients. The intent is to compare these two arms against clinical outcomes from control and treated patients in the EST (6 hours a day for 7 days) using a matched pairs analysis strategy. In this analysis, all patients in the Dosing study are treated with CytoSorb®, and then are later matched and compared to patients from the EST trial using variables in common such as age ≥ 65 years old, need for dialysis, APACHE 2 score, cytokines, and other factors.
There have been 28 patients enrolled into the first arm (24 hours of treatment for 7 days) of the trial to date. Preliminary analysis of the available data suggest the following:
CytoSorb® treatment is well tolerated at flow rates up to 300 mL/min, with no serious device related adverse events in the trial to date. 24-hour treatment increases platelet reduction compared to 6-hour treatment in the EST, but with no reported complications.
CytoSorb® is compatible with a variety of antibiotics including aminoglycosides and broad-spectrum antibiotics, such as the carbepenem class, which require only modest dose adjustments. Additional antibiotic testing is underway.
CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company working to control inflammation and save lives in the ICU through blood purification with its European Union approved CytoSorb® cytokine filter, provides an end-of-year update on its CytoSorb® Dosing study that is currently ongoing.
The CytoSorb® Dosing study ("Dosing study") is a multi-center trial being conducted amongst 8 leading clinical sites in Germany and is an extension of CytoSorbents' previous randomized controlled European Sepsis Trial (EST). The EST demonstrated CytoSorb® was a safe and effective broad spectrum cytokine filter, reducing cytokine storm and key cytokines by 30-50% in patients with septic shock and respiratory failure when used 6 hours a day for 7 days (See summary of the European Sepsis Trial). A post-hoc analysis of the EST clinical data also suggested that patients with either high cytokine levels or 65 years of age or older, benefitted the most from the therapy, including improvements in 28-day and 14-day survival, respectively.
The Dosing study was designed to evaluate the safety and preliminary efficacy of extended CytoSorb® treatment in septic patients with respiratory failure using the same inclusion and exclusion criteria as the EST. The major goals of the study were to:
Obtain safety data on extended CytoSorb® treatment
Confirm CytoSorb® cytokine removal over an extended period of usage
Provide clinicians with more flexibility on how to treat critically ill patients with CytoSorb®
Obtain data to help optimize treatment and support the design of a US pivotal sepsis trial to prove effectiveness. This Dosing study was not intended to produce statistically significant data on clinical endpoints.
Prof Chris Porter, from MIPS said: “The Cancer Australia funding will allow us to develop further our work on drug delivery treatments in lung cancer that we’ve conducted in partnership with Starpharma. More broadly, it’s an exciting time for MIPS and our research partners with the recent announcement of the Centre of Excellence, which will allow us to accelerate and expand our research projects.”
“’Starpharma is a global leader in nanotechnology drug delivery and our relationship with Starpharma is a wonderful example of how researchers can work with companies to advance very promising pharmaceutical products from the lab to the clinic.”
Starpharma Chief Executive Officer Dr Jackie Fairley said: “The prospect of providing lung cancer patients a treatment that improves efficacy and yields lower side effects is highly attractive and we look forward to seeing how this exciting project progresses. We are delighted that a program based on our dendrimer delivery technology has attracted this prestigious cancer funding.”
Starpharma’s dendrimer-based drug delivery technology has been utilised to reformulate already approved cancer drugs such as docetaxel (Taxotere®), oxaliplatin (Eloxatin®) and doxorubicin. Preclinical studies have shown these reformulated drugs to be superior to the commercially available formulation, often in multiple ways including improved efficacy, reduced toxicity and lower side effects. Starpharma is advancing its Dendrimer-Docetaxel into a Phase 1 clinical trial in the New Year.
*Cancer Australia does not publicly disclose the amount of funding provided for individual grants.
Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced that a program utilising its proprietary dendrimer-based nanoparticles which have already shown impressive activity in lung cancer models, have been awarded Cancer Australia funding through its collaboration with Monash Institute of Pharmaceutical Sciences (MIPS).
The Cancer Australia grant was awarded to Dr Lisa Kaminskas and Prof Chris Porter at MIPS under its Priority-driven Collaborative Cancer Research Scheme to develop dendrimer drug delivery systems for the treatment of lung cancer. This grant was part of a total of $4.7 million funding announced by the Federal Health Minister earlier this week*.
The Priority-driven Collaborative Cancer Research Scheme is a competitive national research grant funding scheme which brings together government and other funders of cancer research to collaboratively fund cancer research in Australia.
MIPS was also this week acknowledged as one of Australia's leading nanotechnology research groups being appointed Leader of a new ARC Centre of Excellence in Convergent Bio-Nano Science and Technology . The Centre received $26 million funding which will be used to expand MIPS’ work, and the work of their collaborators in the Centre, in amongst other things, nano-based drug delivery projects. Starpharma has collaborated with MIPS for a number of years on its drug delivery programs, and this was highlighted as a good example of an academic-commercial partnership successfully translating new technologies to market.