MONMOUTH JUNCTION, NJ--(July 17, 2014) - CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company commercializing its CytoSorb® cytokine adsorber in multiple countries worldwide, announced the PDF availability of the first publication describing the use of CytoSorb® intra-operatively during cardiac surgery at the Ludwig Maximilian University of Munich Hospital - Grosshadern Campus, in Germany.
The retrospective study, authored by Frank Born, et al., was recently published in the scientific journal "Kardiotechnik" and entitled, "Systemic Inflammatory Response Syndrome in Heart Surgery: New possibilities for treatment through the use of a cytokine adsorber during ECC?" The study compared the post-operative inflammatory response in 40 patients (20 control vs 20 CytoSorb® treated) undergoing high risk cardiac surgery involving hypothermic arrest and antegrade cerebral perfusion. In the treatment group, CytoSorb® was placed into a bypass blood circuit in the heart-lung machine and used intra-operatively (during surgery) to remove inflammatory mediators from the patients' blood. The control group did not utilize CytoSorb®.
The authors demonstrate that CytoSorb® usage results in a statistically significant decline in inflammatory mediators such as interleukin-6 (IL-6) and procalcitonin in the treatment group, compared to the control group, during the three days after the operation.
OBI-822 is a new anti-cancer treatment that belongs to a new class of active immunotherapies. It is licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). OBI-822 is a synthetic glycoprotein comprised of multiple carbohydrate tumor antigens, Globo H, on a carrier protein, Keyhole Limpet Hemocyanin. OBI-821 is a saponin-based adjuvant that is co-injected with OBI-822.
Globo H is a carbohydrate antigen expressed in high levels on the surface of malignant tumors in many epithelial cancers, such as breast, prostate, gastric, lung, colon, pancreatic, and ovarian cancer. The immunogenicity of the antigen is enhanced by conjugating Globo H to the KLH carrier protein to form OBI-822 (Globo H-KLH), and co-administered with OBI-821.
Stellarklhgold may be onto something:
OBI Pharma Announces Completion of Patient Enrollment in Phase 2/Phase 3 Clinical Trial of OBI-822 Active Immunotherapy for Metastatic Breast Cancer
TAIPEI, TAIWAN, July 22/ -- OBI Pharma, Inc., a Taiwan biotech company (GreTai 4174:TT), announced that it has completed patient enrollment in its Phase 2/3 clinical trial evaluating the safety and efficacy of its lead compound, OBI-822, an active immunotherapy for the treatment of metastatic breast cancer.
“Completing enrollment in the Phase 2/3 clinical trial is a major milestone in the development of OBI-822”, said Michael N. Chang, Ph.D., Chairman of the Board of OBI. “Our next target is a global phase 3 trial – now that there is a current IND with the US FDA and an IND application already submitted in China. We look forward to the results of this trial being confirmed once the course of treatment is completed in all enrolled patients early next year.”
“The cancer active immunotherapy, OBI-822 guides the immune system to attack breast cancer cells, with minimal side effects, [as observed in the OBI’s Phase 1 and Phase 2/3 clinical trials]” said Amy Huang, General Manager of OBI. “OBI-822’s anti-cancer potential goes beyond breast cancer. All tumor cells expressing Globo series glycan (Globo H, SSEA-3 and SSEA-4) are possible treatment targets for OBI-822. According to the latest research findings reported by Taiwan’s Academia Sinica, the Globo H vaccine can potentially treat up to 16 different types of cancer. In fact, OBI Pharma and Mackay Memorial Hospital jointly initiated a Phase 2 ovarian cancer trial in November 2013 which is currently on-going.”
SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB: AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has received independent internal review board (IRB) approval to initiate human clinical studies of Hemopurifier® therapy at DaVita MedCenter Dialysis located in Houston, Texas. Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that would allow for the initiation of Hemopurifier® feasibility studies in the United States. As a result of the independent IRB approval, the Company is now permitted to initiate the IDE approved study. Enrollment of patients who meet the study inclusion/exclusion criteria is expected to begin in the coming weeks. 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.
Upon receipt of IDE approval from FDA, Aethlon initiated discussions with various clinical partner candidates. On February 26, 2014, the Company disclosed that it had reached an agreement in principle with DaVita Clinical Research® (DCR) and subsequently disclosed that it had completed a definitive agreement with DCR on May 20, 2014. 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.
Aethlon further disclosed that Dr. Stephen Z. Fadem had been named Principal Investigator of the IDE approved study. Dr. Fadem is 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.
Under the feasibility study protocol, Aethlon will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier® therapy in an infectious disease model. Upon successful completion of the feasibility study, Aethlon plans to conduct pivotal efficacy studies required for market clearance to treat HCV and other chronic viral indications. Previous clinical studies of Hemopurifier® therapy have been conducted in HIV and HCV-infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India.
Aethlon's feasibility study will also contribute safety data to advance the Hemopurifier® as a broad-spectrum countermeasure against high-risk bioterror and pandemic threats, which are so lethal they do not allow for the administration of clinical efficacy studies.
Starpharma Holdings Ltd (SPL.AX) (SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.
The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.
The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies.
Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia.
The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study.
Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving agreement on the SPA is an important and very positive development as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design. This significantly reduces overall development risk for VivaGel®. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.”
SAN DIEGO, Aug. 6, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
The current ebola outbreak in West Africa demonstrates the urgent need for therapeutic strategies to defend against emerging pandemic threats. It also highlights why the Department of Health and Human Services (HHS) has shifted the focus of government biodefense and pandemic threat initiatives toward broad-spectrum therapies able to target multiple pathogens. At present, a majority of all infectious viruses are not addressed by drug therapies, which are designed to inhibit or block replication of a single viral species.
At Aethlon Medical, we are intersecting advanced biology with modern plasma membrane technology to rethink the treatment of viral pathogens. The result is the Aethlon Hemopurifier®, a therapeutic device that has been validated to capture a broad-spectrum of viral pathogens and immunosuppressive proteins through affinity binding to a unique high-mannose structure that is co-opted from the host (the infected individual) as a means for viruses to evade detection of the host immune system. We have also discovered that this signature exists on tumor-secreted exosomes that promote cancer progression.
We believe our Hemopurifier® is the most advanced and perhaps only true broad-spectrum countermeasure against emerging pandemic threats such as ebola, and viral threats that could be weaponized to purposely infect civilian and military populations. Our belief is supported by human clinical outcomes and supporting in vitro studies conducted at leading government and non- government labs.
Dear Stellar Biotechnologies’ Supporter:
Below are links (sorry, yahoo won't let me post links, google it) to stories released last week regarding two of our collaboration partners.
Stellar long-time customer Neovacs (Paris: ALNEV) discusses the company's immunotherapy programs and pipeline for autoimmune disease
Neovacs is developing the next generation of immunotherapies using Stellar KLH™ as the carrier molecule in three of its products now in clinical development for Rheumatoid Arthritis, Crohn’s Disease, and Lupus.
News regarding OBI-822 Immunotherapy: Clinical trial for breast cancer drug completes patient collection
Stellar is working in collaboration with Amaran Biotechnology, Inc., a privately-held Taiwan biopharmaceuticals manufacturer, to develop and evaluate methods for the manufacture of OBI-822 active immunotherapy using Stellar's GMP grade KLH.
Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.
"We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections."
The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to -- if not higher than -- cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design.
Cellceutix is also pleased to announce the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to commence a Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis.
Oral mucositis is a common and often debilitating inflammation and ulceration in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy that affects nearly half a million people each year. Laboratory studies of Brilacidin-OM have demonstrated antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin-OM as an oral rinse that significantly reduced the duration of oral mucositis by 90 percent or more. There are currently no FDA-approved preventative or therapeutic drugs to treat oral mucositis induced by a broad spectrum of cancer therapies.
"Oral mucositis is an extremely painful condition that often goes overlooked and unpublicized as a side effect for treating hundreds of thousands of cancer patients," commented Leo Ehrlich Chief Executive Officer of Cellceutix. "There is a tremendous market opportunity to treat this condition as it pertains to cancer, as well as in the emerging field of stem cell transplantation. We have a great deal of confidence in initiating this Phase 2 trial and hope this will lead to a drug that offers oral mucositis patients a viable treatment for their discomfort."
Regarding Kevetrin, Cellceutix's lead anti-cancer compound in a dose escalation Phase 1 clinical trial, no drug-related serious adverse events or significant laboratory changes were reported in the eighth cohort in which patients were treated with 215 mg/m2 of Kevetrin. The safety committee yesterday determined that the next 9th cohort may be treated with 350 mg/m2. Patient dosing is scheduled to begin this week.
Starpharma (SPL.AX) (SPHRY) today announced achievement of a major milestone with the receipt of Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.
Starpharma’s marketing partner, Ansell (ANN.AX) plans to launch the VivaGel® condom under their brand, LifeStyles Dual Protect™, in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG). TGA certification will also support certain regulatory processes in other markets.
The VivaGel® condom is a world-first product based on innovative Australian technology. It is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant.
LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the VivaGel® brand and Starpharma will receive royalties based on sales.
Ansell President & General Manager, Sexual Wellness Global Business Unit, Peter Carroll, said:
“Ansell looks forward to rolling out its marketing and sales campaign to support the launch of LifeStyles Dual Protect™ over the coming months with the first product expected to be available on shelves soon.
“Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product. New product development is central to Ansell’s business strategy and this highly innovative product is exciting for both companies.”
Ansell is a global leader in protection solutions, manufacturing and marketing condoms across the world and ranked number two globally. In Australia, Ansell’s share of the condom market is around 70%. The global branded condom market is estimated to be worth approximately $1.1 billion.
Co announced that its Dutch subsidiary, Durata Therapeutics International B.V., has entered into a license and supply agreement with Angelini, an international group leader in the pharmaceutical and mass-market sectors, to commercialize dalbavancin in 36 countries, which include Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and Commonwealth of Independent States.
Durata will receive an upfront payment from Angelini of $15 million and another $10 million upon European Medicines Agency approval. The Co will also receive payments upon the achievement of certain countries' pricing approvals and sales milestones, as well as royalties on sales.
Durata's Marketing Authorization Application for dalbavancin is under review with the European Medicines Agency and anticipates a decision in 1H 2015.
Other than the crickets, I may be the only other person besides you visiting this board. This company has so much potential and the owner is a good and decent person to boot. They're getting ready to uplist and they have some big backers in the health world so it wouldn't surprise me a bit to see them start to get more exposure. The Lucrazon deal should begin to gain traction soon and with a little luck economy wise, it could be off to the races soon.
SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has initiated coverage on Aethlon Medical, Inc. (AEMD), a medical device company focused on creating innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions.
"We see the core of AEMD’s developments in the Aethlon ADAPT(TM) (Adaptive Dialysis-Like Affinity Platform Technology) system, a medical device platform that forms the basis for a new class of therapeutics that target the rapid elimination of disease enabling particles from the circulatory system of treated patients. The lead Aethlon ADAPT(TM) product is Hemopurifier(R), a first-in-class device that addresses a broad spectrum of viral pathogens as well as tumor-secreted exosomes that suppress the immune system of cancer patients," commented Ajay Tandon, CEO of SeeThruEquity. "We are initiating coverage with a target price of $0.34."
To do so, the DLT program seeks to develop multiple component technologies, integrate them into a portable device, and rigorously validate device effectiveness. Key technical areas and representative technical approaches include:
Persistent interrogation of the entire blood volume via sensing technologies such as surface enhanced Raman spectroscopy (SERS). This capability may enable early identification of bacteria, viruses, toxins, and cytokines.
High-flow fluid manipulation without the use of anticoagulants via novel biocompatible/biomimetic architectures and advanced surface functionalization chemistries.
Continuous removal of pathogens, toxins, activated cells, exosomes, and cytokines via a diverse suite of "label-free" technologies such as synthetic mannose binding lectins and selective adsorption cartridges.
Closed-loop therapy with system feedback to monitor and redirect patient state based on conditional probability and reduced order techniques.
The integration and validation of these component technologies focuses on establishing a path to FDA Investigational Device Exemption (IDE) before the completion of the program. From there, the device will be available for transition to military medical commands and clinical trials required for final regulatory approval.
In addition to treating sepsis, the DLT device represents a flexible platform that may be configured to combat engineered and evolving pathogens.
Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, disclosed today that the Defense Advanced Research Projects Agency (DARPA) has informed the Company that it plans to exercise an option to proceed with year four of a five-year $5.9 million contract that was awarded to Aethlon on September 30, 2011 under DARPA's Dialysis-Like Therapeutics (DLT) program.
The fourth year of Aethlon's DLT contract contains three milestones representing a potential of $669,292 in revenue opportunity. To date, Aethlon has invoiced $4,252,037 to DARPA for achieving twenty of twenty-three milestone objectives targeted in the first three years of the DLT program.
The goal of the Dialysis-Like Therapeutics (DLT) program is to develop a portable device that removes "dirty" blood from the body, separates harmful agents, and returns "clean" blood to the body in a manner similar to dialysis treatment of kidney failure. The resulting device could decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States annually.
In consequence of recent public notices about the rapid expansion of its national affiliate marketing network and agreements with major trading partners, and pursuant to its public assurances that Green PolkaDot Box Incorporated (GPDB) "GPDB" or "Company" will become fully reporting in 2014, the Company announces that it has retained Salt Lake City-based Tanner & Company, an independent, regional accounting firm.
In a related move, GPDB has also hired Christopher Foley to act as its full-time CFO and assist Tanner & Company with completion of the audit work and meeting public reporting requirements. Mr. Foley brings over 28 years of diverse business and financial management experience to GPDB after working for several renowned Fortune 100 companies, including General Electric, Johnson & Johnson and American Express Financial Advisors, as well as several large financial institutions including PNC Bank and Zions Bank.
The hiring of Mr. Foley and retention of Tanner & Company is calculated to position the Company to increase shareholder value and liquidity.
GPDB CEO, Rod Smith, commented on the timing of this strategic move: "As we contemplate the positive impact and potential of our new sales and marketing opportunities; diversity of operations into private label, 3PL services; and the production and expansion of Living Produce(R) it has become imperative that we serve the best interests' of our shareholders by preparing to uplist to a major exchange."