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.”
From a 2010 Pinnacle report:
Stellar is the only company in the world with a proprietary technique of extracting the KLH protein from the Keyhole Limpet without killing it (the key to Stellar Biotechnologies - it has intellectual property (IP) to create a renewable source of KLH).
* Stellar appears to be the only company in the world with a multi-million dollar aquaculture center that is fully-scalable and home to thousands of Keyhole Limpets.
* The value of KLH, depending on the grade, sells for between $4,000 and $200,000 dollars per gram.
* Stellar has over 70,000 spawned and juvenile Keyhole Limpets and, when fully-grown, each can produce an average of about 1 gram of KLH per year.
* Stellar is currently expanding its aquaculture farm of Keyhole Limpet's to meet rising demand and aims to have more than 200,000 within the next few years.
* Several of the largest drug companies in the world are currently testing vaccines which utilize large quantities of KLH.
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.
Where do you see that it was denied? I do see that they submitted a form for Add-on Payments:
Centers for Medicare &Medicaid Services
Center for Medicare Management
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Tracking Form for Applicants for New Technology Add-on Payments under the Acute Inpatient
Prospective Payment System (IPPS) for Federal Fiscal Year (FY) 2015
1. Technology Name: Dalbavancin, an intravenous (IV) antibiotic.
2. Manufacturer Name: Durata Therapeutics, Inc.
3. Trade Brand of Technology: The proposed trade/brand name of the new technology is: Dalvance.
4. Brief Description of Service, Device or Drug:
Dalbavancin is a new intravenous (IV) lipoglycopeptide antibiotic administered as a once
weekly 30 minute infusion via a peripheral line for the treatment of patients with acute bacterial
skin and skin structure infections, or ABSSSI. Dalbavancin's unique pharmacokinetic profile
demonstrates rapid bactericidal activity that is potent and sustained against serious Gram
positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin's
once-weekly dosing, a simpler regimen than the current standard of care of daily or multiple
times daily intravenous dosing, allows for the discontinuation of IV access with its attendant
risks of line-related thrombosis and infection.
Dalbavancin's mechanism of action involves the interruption of cell wall synthesis resulting in
bacterial cell death. In vitro and in vivo nonclinical microbiology and pharmacology data
provide evidence for the potential therapeutic usefulness of dalbavancin in the treatment of
clinical infections caused by gram-positive bacteria, including MRSA. The feature that
differentiates dalbavancin from existing antibacterial agents active against MRSA is its long
half-life, which allows use of a once-weekly treatment regimen; a complete course of therapy
consists of single doses of dalbavancin administered on Day 1 and 8.
"Seperately, AstraZeneca was among the companies speculated to be interested in Durata Therapeutics, a US-listed superbug antibiotic developer. Takeover gossip led Durata shares to jump on Monday, giving the group a market value of about $385m." From The Financial Times article entitled:
High cost to AstraZeneca independence
Key Word : Among
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.
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.
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."
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.
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.
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.”
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.