Can you say Cha Ching?
Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that a research collaboration with Fox Chase Chemical Diversity Center has led to the award of a Phase 2B Small Business Innovation Research (SBIR) grant to FCCDC from the National Institute of Allergy and Infectious Disease (NIAID) of the National Institute of Health (NIH).
The SBIR grant is for up to $1.5 million over two years and research will be directed at developing the Cellceutix technology platform on host defense protein (HDP) mimics for treatment of disseminated fungal infections, particularly those caused by Candida species.
"This grant to research our novel compounds dovetails with our strategy to partner with leading organizations and universities in the development of new therapeutic agents for some of the most difficult to treat fungal and bacterial infections," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Candida infections were recently named in the final rule of the U.S. Food and Drug Administration's list of qualifying pathogens under the Generating Antibiotic Incentives Now Act. We clearly see the potential and value of new drugs for Candida infections and are very pleased that the funding is now in place for FCCDC to conduct studies on our compounds in this area."
Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, today announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. The published data demonstrates the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following reversal associated with REG2.
REG2 is a two-component system consisting of a subcutaneous depot formulation of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary intravenous injectable oligonucleotide active control agent, anivamersen. REG2 is being developed to be the preferred therapeutic option in high value sub-acute venous thrombosis indications such as DVT and VTE prophylaxis. REG2 will be an important part of the life cycle franchise strategy associated with Revolixys™ Kit which ultimately entails broad use throughout the hospital.
Christopher Rusconi, Ph.D., Regado's Chief Scientific Officer and co-discoverer of the Regado controllable aptamer technology, commented, "These results support the choice of FIXa as an excellent target for anticoagulant therapy. In addition, the concentration-dependent inhibition of thrombin generation observed in this study further supports the pegnivacogin dose selected for the REGULATE-PCI Phase 3 study of the companion product candidate, Revolixys™ Kit."
AFFiRiS develops synthetic vaccines against chronic diseases with unmet medical needs and attractive markets. The antigens of these vaccines are short peptides which function as B-cell epitopes. The aim of an AFFITOPE vaccination is to induce antibody immune responses which will address each target structure with the relevant appropriate specificity. Cytotoxic T-cell responses and autoimmune helper T-cell induction are excluded simply because the peptides used are too small to trigger the respective pathways. The T-cell help required is provided by a carrier protein such as KLH covalently linked to the peptides.
Ok total moron, take your bashing and low IQ to another board cause you are now on ignore!
I'd venture a guess you'll be eating these words this time next year. The owner is a trustworthy man and has done it once before as he founded and CEO'd inContact, INc. He's not diluting, check out the innovative ways he's raising cash. He's got some folks with big money backing him and I for one am going aLONG for the ride.
We have updated our report on Aethlon Medical (AEMD) for several recent developments. See below for access to our full report on the company.
DaVita Agreement for Pilot Study Finalized
Earlier this month AEMD announced that they entered into a definitive agreement with DaVita Clinical Research (DCR), the CRO arm of dialysis services giant DaVita Healthcare, to provide clinical management services for Aethlon's recently approved 10-patient feasibility study. As a reminder, Aethlon first announced in February that they reached a preliminary agreement with DCR to manage the study - which was a change of course as AEMD had previously disclosed the study was expected to be conducted by the Renal Research Institute, a partnership between Fresenius Medical Care (FMS) and Beth Israel Medical Center in NYC. The pivot towards DCR was driven by the potential to leverage DCR's dialysis-related clinical trial experience, their large clinical site network and the expertise of Dr. Stephen Fadem, who will be leading the study.
The feasibility safety study, which will enroll 10 ESRD patients with HCV, will be conducted at the DaVita MedCenter Dialysis clinic in Houston, TX - one of the largest dialysis centers in the U.S. - which could presumably support future, larger HCV studies as well. AEMD hopes to obtain IRB approval and commence enrollment by this summer. We note that DaVita MedCenter is also in close proximity to MD Anderson Cancer Center - which potentially opens up the possibility to collaborate with DCR and Dr. Fadem on future cancer-related studies as well.
Initial marketing blitz could change the game altogether and results can be seen in real time.
Creative, non-dilutive financing plan to speed things up, but not a deal breaker if it fails.
A successful uplisting accompanied by membership expectations being met can result in significant stock price appreciation.
Aethlon Medical, Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced high rapid virologic response (RVR) and sustained virologic response (SVR) rates in Hepatitis-C virus (HCV) infected individuals who were administered Hemopurifier® therapy.
The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of viral pathogens and tumor-secreted exosomes from the entire circulatory system to improve the benefit of drug therapies administered to infectious disease and cancer patients. In HCV care, the device is positioned to address drug resistance associated with emerging all-antiviral therapies and also targets to accelerate HCV RNA depletion at the outset of peginterferon+ribavirin (PR) therapy.
Aethlon recently disclosed that the United States Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) that now allows the Company to initiate HCV human feasibility studies of Hemopurifier® therapy in the United States. Aethlon announced yesterday that its first U.S. clinical study will be conducted at the DaVita MedCenter Dialysis in Houston, Texas. It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.
Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) announced today the launch of its corporate video highlighting the Company's business of manufacturing Keyhole Limpet Hemocyanin (KLH) protein. KLH is an immune-stimulating molecule widely used in the growing field of immunotherapy.
The video is available for viewing on Stellar's website
The corporate video provides an overview of Stellar's commercial position in immunotherapy development. It includes interviews with Company executives and was filmed at Stellar's California-based aquaculture research and production facilities where Stellar KLH™ protein is manufactured for use as a vaccine carrier molecule or for immunotoxicology applications.
"We have a dedicated team of scientists and personnel working in a unique environment that combines pharmaceutical manufacturing and marine technologies," said Frank Oakes, President and CEO of Stellar. "We are pleased to give viewers this glimpse at our pioneering work in scalable manufacture of sustainable GMP grade KLH."
About DaVita Kidney Care
DaVita Kidney Care is a division of DaVita HealthCare Partners Inc., a Fortune 500® company that, through its operating divisions, provides a variety of health care services to patient populations throughout the United States and abroad. A leading provider of dialysis services in the United States, DaVita Kidney Care treats patients with chronic kidney failure and end stage renal disease. DaVita Kidney Care strives to improve patients' quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of March 31, 2014, DaVita Kidney Care operated or provided administrative services at 2,098 outpatient dialysis centers located in the United States serving approximately 165,000 patients. The company also operated 75 outpatient dialysis centers located in 10 countries outside the United States. DaVita Kidney Care supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company's leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu.
He is a Fellow of the American College of Physicians, Fellow of the American Society of Nephrology, diplomat of the American Board of Quality Assurance and Utilization Review Physicians (CHCQM - Certified Health Care Quality Management), and a member of the International Society of Nephrology, Renal Physicians Association, the American Association of Kidney Patients and The National Kidney Foundation. He is active in quality management, credentialing and peer review for his dialysis centers.
On a national level, he is co-chairman of the Medical Advisory Board of the American Association of Kidney Patients, and a past vice-president of the Board of Directors. He has also served on the Board of Directors of the Renal Physicians Association, and actively serves on two national RPA committees, the Government Affairs Committee and the Health Finance Committee. Dr. Fadem has been active in the Forum of ESRD (end stage renal disease) Networks and was a member of the CMS Clinical Performance Measures Committee. He lectures frequently on dialysis management, preventive nephrology, vascular calcification, anemia, patient education, CKD education, computer technology and computer security. Dr. Fadem is a co-editor of AAKP Renalife and is a reviewer for several peer reviewed journals.
Dr. Fadem has been nationally recognized by receiving the American Association of Kidney Patient's Nova Award, the National Kidney Foundation's Distinguished Service Award. He has also received the National Kidney Foundation's Presidents Award and the Myron L. Jenkins Award. He has been awarded the Peter Lundin Award for his contributions to patient education and The Visionary Award for his contributions to CKD education. He is the 2013 winner of the DaVita Core Value Award for Continuous Improvement. He has been named as one of America's Top Doctors by Castle Connolly and US News and World Report, and is consistently ranked as a Top Doctor in Houston by Texas Magazine.
"The combination of DCR, DaVita MedCenter Dialysis, and Dr. Fadem provides Aethlon with the ideal team of professionals and infrastructure with which to conduct our infectious disease clinical study. Additionally, their proximity to M.D. Anderson Cancer Center and other specialty facilities located within the Texas Medical Center provide for a unique location to conduct future clinical investigations of Hemopurifier® therapy in a variety of life-threatening health conditions," stated Aethlon Medical CEO Jim Joyce.
DCR is a specialty contract research organization (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners Inc, DCR has access to one third of the total U.S. ESRD patient population and maintains a network that exceeds 150 investigative physicians' practices at more than 250 clinical sites.
Dr. Fadem is a practicing Houston nephrologist and is currently the Chief Medical Officer at Kidney Associates, PLLC and the Medical Director for the Houston Kidney Center Integrated Service Network at DaVita Kidney Care, a division of DaVita HealthCare Partners Inc. He began practice in 1978 after completing a renal fellowship at The University of Texas Health Science Center in San Antonio. He is a graduate of the University of Oklahoma College of Medicine, and did his internal medicine residency at The University of Texas and MD Anderson Hospital in Houston. He is a Clinical Professor of Medicine at Baylor College of Medicine.
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 it has entered into a definitive agreement with DaVita Clinical Research (DCR) to provide clinical management services to support the forthcoming feasibility study of the Aethlon Hemopurifier®. The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon further announced that the Principal Investigator for this study will be Dr. Stephen Z. Fadem.
The clinical trial site location will be DaVita MedCenter Dialysis in Houston. Dr. Fadem is co-medical director of DaVita MedCenter Dialysis and this center is one of the three largest dialysis centers in the country with 72 treatment stations.
Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier in the United States. Under the feasibility study protocol, Aethlon is to treat ten ESRD patients infected with Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.
PORT HUENEME, CA -- (Marketwired) -- 05/15/14 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) announces that Company Executives are scheduled to present at two upcoming conferences.
Marcum MicroCap Conference at the Grand Hyatt in New York City on May 29, 2014 @ 2:00 PM EST (11:00 AM PST)
Stansberry & Associates Investment Research Conference at the AT&T Performing Arts Center, Dallas, TX on May 31, 2014
Frank Oakes, President and CEO of Stellar Biotechnologies, will present at both events and members of Stellar's executive team will be available for one-on-one meetings. A link to the Marcum conference webcast will be available in the Investor Relations section of the Company's website
Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
The discovery that our Hemopurifer® captures tumor-secreted exosomes provides hope for a new therapeutic paradigm to augment cancer care. Yes, the same Hemopurifier® we are preparing to advance in a forthcoming FDA approved infectious disease study. In my last CEO note, I referenced a National Institute of Health (NIH) – National Cancer Institute (NCI) sponsored article that referenced Hemopurifier® therapy as a candidate to address tumor-secreted exosomes.
The article detailed several exosomal mechanisms that promote cancer progression, including suppression of the immune system, triggering resistance to cancer therapies, promotion of angiogenesis and seeding the spread of metastasis. The article also indicated that high levels of circulating exosomes correlated with advanced stage cancer.
As researchers continue to unravel the deleterious mechanisms of exosomes underlying cancer, it has become clear that these particles also transport many molecular targets of interest to the pharmaceutical industry. Thus providing further support for a medical device that is able to target circulating exosomes without adding drug toxicity to established cancer therapies.
In this regard, I am pleased to share the following overview authored by Dr. Annette Marleau (our Director of Tumor Immunology), which outlines oncology targets of the pharmaceutical industry that have been reported to be transported by exosomes.
Getting the word out:
Stellar Biotechnolgies announced today it has retained Stonegate, Inc. ("Stonegate") to provide institutional investor outreach and capital markets advisory for the Company pending regulatory approval.
"Stellar has reached a key point of our business development and immunotherapy research program where we believe we are well positioned to increase our institutional outreach efforts. Our core business of manufacture and supply of KLH protein continues to strengthen our position to negotiate alliances with commercial partners in parallel with their clinical successes. We continue to make breakthroughs in aquaculture science and our immunotherapy program targeting Clostridium difficile ("C. diff") is on track to deliver data midsummer. These achievements coupled with our strong financial position to support our efforts, reinforces my confidence that we have a compelling story to tell," said Frank Oakes, president and chief executive officer of Stellar Biotechnologies. "Stonegate's team has more than a 40-year track record of success connecting growth companies with institutional investors. Their highly focused approach to deliver effective and innovative targeting solutions should help expand our institutional awareness and shareholder base."
Stonegate is a 40-year old research, capital markets advisory and investment banking boutique dedicated to serving the specialized needs of small-cap public companies. Stonegate provides research, sales and trading, corporate finance, strategic advisory and investor relations' services to a select group of clients. They work with the leading institutional investors in the U.S. and Europe who are seeking high quality investment opportunities in the small cap marketplace.
Stonegate will receive a fee of US $5,000 per month for six months through September 30, 2014, with an optional monthly renewal thereafter. The agreement may be cancelled after the initial six-month term upon 10 days written notice.
Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2014.
The cash balance at 31 March 2014 was $27.8 million. This strong cash position was assisted by the receipt of $4.7 million of R&D tax incentive relating to FY13 expenditures.
The March quarter saw a high level of activity for the Company. The DEPTM docetaxel Phase 1 trial commenced in January, with the first patient cohort now enrolled and commenced treatment. Multiple clinical trial preparations have also occurred for the Phase 3 VivaGel® bacterial vaginosis (BV) prevention program during the quarter. Expenditure for the quarter included the manufacture of clinical trial product for both the DEPTM docetaxel and VivaGel® clinical trials.
Preparation for Phase 3 clinical trials for VivaGel® to prevent recurrent BV are now well advanced. During the period, activities undertaken in preparation for the commencement of this multi-site trial program include site selection, briefing of clinical investigators, site preparation, ethics submissions, and clinical product manufacturing. The company expects to commence the trials shortly.
Starpharma has made significant advances related to its VivaGel® BV symptomatic relief product, including discussions with several key regulatory bodies. The Company is now preparing for regulatory submissions in key markets in coming months, in parallel with ongoing positive discussions with commercial partners.
In March, Starpharma announced that its commercial partner in Japan, Okamoto Industries, received regulatory approval for the VivaGel®-coated condom in that country, and the Company is working with Okamoto in preparation for product launch.
In addition, Starpharma continues to work closely with Ansell Limited towards regulatory approval and subsequent launch of the VivaGel®-coated condom in a number of markets. Ansell has rights to the VivaGel®-coated condom in countries outside Japan.
In early April, Starpharma announced an expanded agreement with AstraZeneca in the field of cancer medicine using Starpharma’s proprietary DEP™ dendrimer drug delivery technology.
Starpharma Chief Executive, Dr Jackie Fairley, said: “The first quarter of 2014 has been a very active period for Starpharma as we advance a number of clinical trial and regulatory processes related to the VivaGel® suite of products and our drug delivery programs. It has also been a period of significant commercial advancement with the VivaGel®-coated condom now approved for launch in Japan, licensing discussions for BV continuing positively, and our agreement with AstraZeneca extended to develop dendrimer enhanced cancer products.”
When we initiated our first exosome research program, the medical community generally viewed these particles as nothing more than cellular debris with no biological function. In contrast, we believed that exosomes, also known as microvesicles or extracellular vesicles, suppressed the immune system of cancer patients and that stage of cancer progression correlated directly with quantity of exosomes in circulation. We envisioned the possibility that a medical device could eliminate circulating exosomes and combine to improve the benefit of established cancer therapies without adding drug toxicity.
Today, I am pleased to inform you that a team of researchers from Harvard Medical School, Massachusetts General Hospital and University of Oxford have published a review article that validates the original rationale of our exosome research and further reinforces our future plan to submit an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) that requests permission to initiate Hemopurifier® studies in cancer patients.
The article entitled: "Extracellular Vesicles: Emerging Targets for Cancer Therapy" is published in the current issue of the journal "Trends in Molecular Medicine".
The article reviews recent discoveries that have increased the understanding of extracellular vesicles (EV's) role in tumor development and progression, including immune suppression, angiogenesis, and metastasis. On the basis of this understanding, EV's have emerged to be targets for anticancer therapy. The article then discusses novel therapeutic strategies to target EVs to prevent tumor growth and spread. In this regard, Aethlon Medical is the only organization referenced based on our extracorporeal device strategy to target the elimination of exosomes from circulation of cancer patients.