Samstag, 12. April 2014
Oxigene Is One Of The Most Undervalued Cancer Stocks In Biotech Area With A Huge Upside Potential Into A Billion Dollar Market
Oxigene Cancer Combo drug reduced the risk of tumor regrowth or death (progression-free survival) by 32 % compared to Roche's Blockbuster Avastin ( 6 billion sales )!! Oxigene is one of the most undervalued cancer stocks in biotech area with a huge upside potential into a Billion dollar market !! Oxigene is trading at cash flow level with 5 Big Catalyst ahead in the next weeks or Month's !! Oxigene inc Cancer Therapy Provides Multi-Bagger Opportunity , 100% EMA approval based on PFS alone ** the full data NCI/GOG will present 2nd half 2014 for the first time for Avastin in Combination With ZYBRESTAT for Recurrent Ovarian cancer $OXGN listed on ETA 2014 meeting http://www.eta2014.com/exhibitors-and-sponsors.html … later come ESMO 2014**** Oxigene Announces Positive Topline Results From Randomized Phase 2 of ZYBRESTAT(R) in Combination With Avastin(R) for Recurrent Ovarian Cancer . On the study's primary endpoint, the combination of Zybrestat and Avastin reduced the risk of tumor regrowth or death (progression-free survival) by 32% compared to Avastin alone. The result was very statistically significant***Roche's Avastin is not approved for ovarian cancer in the U.S.(A Roche spokesman said an FDA submission is planned for later this year.) *** Zybrestat could be extremely helpful to Avastin in gaining FDA approval for ovarian cancer ***Jul 18, 2013 OXIGENE ANNOUNCES GRANTING OF ORPHAN DRUG STATUS IN EUROPE FOR ZYBRESTAT IN OVARIAN CANCER **** Roche's Avastin worldwide sales 2012: $ 6 Billion *** Oxigene inc & GlaxoSmithKline announces ongoing PAZOFOS: Phase Ib and Phase II Trial of Pazopanib Fosbretabulin in Advanced Recurrent Ovarian Cancer *** investors expect here a possible Partnership or Buyout with Novartis or Roche into ZYBRESTAT presentation in the next months *** OXIGENE has a first class VDA Platform and it's still under Investors radar ** Oxigene current M.Cap reflect not their pipeline and potential for ZYBRESTAT(R) in combination with Avastin *** some information for investors -----> over 30 years research support. ZYBRESTAT has 400 patients tested for both safety and efficacy.ZYBRESTAT will be approved for ATC tumor in Europe ****ECYT 25 % progression-free survival 250 Million M cap and Oxigene inc 32% progression-free survival 50 Million M cap with 38 Million Dollar cash on hands *** OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancers, such as ovarian and certain thyroid cancers. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumors. OXiGENE is dedicated to leveraging its scientific expertise, intellectual property and therapeutic development capabilities to bring life-extending and life-enhancing medicines to patients.*** About VDAs Vascular Disrupting Agents or "VDAs" block blood flow through established tumor blood vessels, thereby starving tumors of oxygen and essential nutrients, leading to tumor cell death.**** The phase II study, conducted by the non-profit Gynecologic Oncology Group, not Oxigene, enrolled 107 women with platinum-sensitive and resistant, recurrent ovarian cancer. The patients were randomized to receive either Roche's Avastin alone, or a combination of Zybrestat and Avastin. On the study's primary endpoint, the combination of Zybrestat and Avastin reduced the risk of tumor regrowth or death (progression-free survival) by 32% compared to Avastin alone. The result was very statistically significant ****Oxigene owns all rights to Zybrestat. ** some facts about Oxigene inc 15.2 Million Shares = 50 Million Market CAP and $38 million Cash !!*** Oxigene inc current market cap reflects not the Cancer Pipeline www.oxigene.com/product-development *** Here's some information taken directly from the OxiGENE BIO CEO Conference presentation. Current chemotherapy is notorious for killing healthy cells along with cancerous ones - The Zybrestat/Avastin combination is designed to change that. Zybrestat kills tumor cells by selectively blocking the blood vessels that carry vital oxygen and nutrients to tumors. Let's keep it simple and give you these Fact Results: One-year survival rate 25.5% vs. 8.7% Median Overall Survival 5.2 vs. 4.0 months (HR 0.72) 25% higher Objective Response rate (20% vs. 16%) VDAs reduced blood flow to the center of the tumors by 70% ***** Abstract VDAs - Oxgn leading the way.. OXi4503 ***** The tumor vasculature of solid tumors offers unique characteristics compared to the normal vasculature and, therefore, represents an attractive target in anti-cancer therapy. Besides the classic anti-angiogenic agents, which inhibit tumor neovascularization, a novel promising class of anti-tumor drugs has emerged in the last years, the vascular-disrupting agents (VDAs). In contrast to angiogenesis inhibitors, VDAs act on already established tumor blood vessels of large solid tumors and induce a vascular shutdown by targeting tumor endothelial cells. This results in extensive necrotic tumor cell death. The sources of VDAs are quite divers, however, the plant-derived compounds represent the largest and most prominent class. Plant-derived VDAs have undergone extensive preclinical investigations and are now tested in several advanced clinical trials. In this review we summarize preclinical data, including drug-target relationships as well as functional in vitro and in vivo assays, discuss their molecular way of action, and update the clinical status of the most prominent plant-derived VDAs: FAA/DMXAA, CA-4-P, OXi4503, AVE8062, and ZD6126. All these data emphasize the value of secondary plant metabolites and their (semi-)synthetic derivatives for current drug discovery. **** for more information please visit www.oxigene.com www.oxigene.com/science/about-vdas/video clinicaltrials.gov/ct2/results?term=oxig...
Freitag, 4. April 2014
Oxigene inc waiting for EU MAA Approval *** OXiGENE believes that ZYBRESTAT is poised to become an important product in a novel class of small-molecule drug candidates called vascular disrupting agents. Through interaction with vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. In clinical trials in solid tumors, ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against anaplastic thyroid cancer, ovarian cancer and various other solid tumors.*** March 11, 2014 Oxigene OXiGENE Announces Positive Topline Results From Randomized Phase 2 Study GOG186I of ZYBRESTAT(R) in Combination With Avastin(R) for Recurrent Ovarian Cancer ***On the study's primary endpoint, the combination of Zybrestat and Avastin reduced the risk of tumor regrowth or death (progression-free survival) by 32% compared to Avastin alone. The result was statistically significant ****March 27, 2014 OXiGENE Announces Presentation of Three Preclinical Abstracts at 2014 AACR Conference also Oxigene inx ; April 6 , 7 , 8 2014 Three Presentation in 3 days at 2014 AACR Conference ****** ( March 21, 2014 Endocyte Announce European CHMP Positive Opinions for VYNFINIT® (vintafolide) and Companion Imaging Agents FOLCEPRI® (etarfolatide) and NEOCEPRI® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant Ovarian Cancer with(progression-free survival) by 25% **** April 4, 2014 Endocyte Announcesanother Panic P.R ---> 3 posters will be presented by Endocyte scientists at the .Presentations at AACR Annual Meeting 2014** these guys from Endocyte are really worried and in Panic +++ some facts OXGN 32% PFS vs ECYT 25% ***** . OXGN CASH is about 38 Million Dollar and current Market cap 42 mil & ECYT M cap 240 mil*** Oxigene has a Big Pipeline **** ++++++ Wall Street like undervalued stocks like $OXGN *** Partnering or Buyout expected soon + Oxigene inc Announces 3 Presentation in 3 days at 2014 AACR Conference !! April 6 , 7 , 8 2014 *** OXiGENE, Inc. (OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced that data from three studies related to its early stage scientific programs will be presented at the Annual Meeting of the American Association of Cancer Research (AACR) being held April 5-9, 2014 at the San Diego Convention Center in San Diego, CA.** OXiGENE Announces Results of Promising Preclinical Studies at 2014 AACR Conference ** **** OXiGENE, Inc. (OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced that data from three studies related to its early stage scientific programs will be presented at the Annual Meeting of the American Association of Cancer Research (AACR) being held April 5-9, 2014 at the San Diego Convention Center in San Diego, CA *** Details on the three poster presentations are as follows: Title: Vascular-based Strategies for Enhancing Tumour Response to Radiation Administered in a Stereotactic Schedule Authors: Michael R. Horsman, Ph.D. and Thomas R. Wittenborn, Ph.D. Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark Abstract: 850 Session Title: Radiation Oncology: Modifiers and Signal Transduction, Sensitivity, Resistance, and Therapy Session Category: Experimental and Molecular Therapeutics 7 Date/Time/Location: Sunday, April 6, 2014 1:00 -- 5:00 p.m. Halls A-E, Poster Section 35 Title: Assessment of Anti-Tumour Activity of the Cathepsin L Inhibitor, KGP94 Authors: Thomas R. Wittenborn, Ph.D.1, Michael Stratford, Ph.D.2, Mary Lynn Trawick, Ph.D.3, Kevin G. Pinney, Ph.D.,3 David J. Chaplin, Ph.D.4, Dietmar W. Siemann, Ph.D.5, Michael R.Horsman, Ph.D.1 1Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark 2Gray Institute for Radiation Oncology and Biology, University of Oxford, Oxford, U.K. 3Department of Chemistry and Biochemistry, Baylor University, Waco, Texas, U.S.A. 4OXiGENE Inc., South San Francisco, California, U.S.A. 5Department of Radiation Oncology, University of Florida, Gainesville, Florida, U.S.A. Abstract: 1816 Session Title: Novel Targets 1 Session Category: Experimental and Molecular Therapeutics 14 Date/Time/Location: Monday, April 7, 2014 8:00 a.m. -- 12:00 p.m. Halls A-E, Poster Section 33 Title: In-vivo Evaluation of the Anti-metastatic Efficacy of Small Molecule Cathepsin L Inhibitor KGP94 in a Prostate Cancer Model Authors: Dhivya Sudhan, Ph.D.1 and Dietmar W. Siemann, Ph.D.2 1 Department of Pharmacology & Therapeutics, University of Florida, Gainesville, Florida, U.S.A. 2Department of Radiation Oncology, University of Florida, Gainesville, Florida, U.S.A. Abstract: 4030 Session Title: Therapeutic Approaches for Metastatic Tumors Session Category: Tumor Biology Date/Time/Location: Tuesday, April 8, 2014, 1:00 -- 5:00 p.m. Halls A-E, Poster Section 7 About OXiGENE OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. The Company is focused on developing vascular disrupting agents (VDAs), which are compounds that selectively disrupt abnormal blood vessels associated with solid tumor survival and progression. The Company's lead clinical product candidate, ZYBRESTAT(R), is in development as a potential treatment for solid tumors. OXi4503, its second-generation product candidate, is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Donnerstag, 6. März 2014
*** 443 Nuclear Reactors could more than Double in the next 15 years *** Embargo against PUTIN !!!! Russia have 50% off all URAN resources in the world ***many Analyst expect a Hugh run up for Uran producers in the next Time and years *** ** World leaders need to take action on the energy crisis that is taking shape before our eyes. Oil & Gas prices are soaring and it looks less and less likely that this is a bubble. The price of coal has doubled. Countries as far apart as South Africa and Tajikistan are plagued by power cuts and there have been riots in several nations because of disruptions to electricity. Rich states, no longer strangers to periodic blackouts, are worried about security of energy supply. In the developing world, 1.6 billion people � around a quarter of the human race � have no access to electricity. I believe that fundamental changes are underway in the energy field whose significance we have not yet fully grasped. Global demand for energy is rising fast as the population increases and developing countries such as China and India undergo dramatic economic growth. The International Energy Agency (IEA) says the world�s energy needs could be 60% higher in 2030 than they are today. *** The point here is ** The URAN price climb in the next years to all Time High ** why ??? India & China are Power hungry counties ** China have massive problem with SMOG dirty Air , Japan have no own resources they have no other choice to use Uran electric Power *** There are 443 nuclear power reactors operating in 31 countries in Asia, Eastern Europe and the Middle East also embracing nuclear power in response to high fossil fuel prices and concerns about global warming — the world’s stock of 443 nuclear reactors could more than double in the next 15 years, according to the World Nuclear Association, an industry trade group. plus Taiwan, with a combined capacity of over 370 GWe. In 2011 these provided 2518 billion kWh, about 13% of the world's electricity. *** 2014 potential catalysts: Restarting of nuclear reactors under Japan’s new Basic Energy Plan & expired HEU1 between US and Russia World’s nuclear reactors supplied about 13% of global electricity in 2011 Aggressive global reactor construction program 68 nuclear power facilities currently under construction or planned to start Four expansions currently underway in U.S. Deferrals & reductions in future uranium supply Many producers have delayed or cancelled high cost mining projects Uranium spot pricing remains challenging at ~$35/per pound; Long term at $180.00/per pound3 *** $URRE Corporate Overview will profit from the upcoming URAN BOOM in the next years ** some analyst expect All Time High at Uran price in the next years i expect a share price over $150 for $URRE in the next years ** Uranium Resources,inc $URRE is a uranium exploration, development and production company. organized in 1977 to acquire and develop uranium in South Texas using the in-situ recovery process (ISR). URI has historically produced uranium by ISR methods in the state of Texas where the Company currently has ISR projects, including two licensed processing facilities. also have 206,600 acres of mineral holdings in New Mexico and an NRC license to produce up to 3 million pounds per annum of uranium on certain of its New Mexico projects **** There is act of WAR for Energy OIL & GAS $ URAN World Wide !!! IRAK = OIL & Libya = OIL & Syria Oil Gas pipeline from Irak ; Afganistan Uran resources some words about The Ukraine, which imports most of its gas, may soon have its own shale gas boom !! the Ukraine has Europe's third-largest shale gas reserves at 1.2 trillion cubic meters (tcm) !! Europe need NO Gas from Russia !! Ukraine signs $10 billion shale gas deal with Chevron *** Russia » (Reuters) - Ukraine signed a $10 billion shale gas production-sharing agreement with U.S. Chevron (CVX.N) another step in a drive for more energy independence from Russia. The deal to develop its western Olesska field followed a similar shale gas agreement with Royal Dutch Shell (RDSa.L) in January and boosts Ukraine's leadership at a time of fraught relations with Moscow over gas supplies. "The agreements with Shell and Chevron ... will enable us to have full sufficiency in gas by 2020 and, under an optimistic scenario, even enable us to export energy,"the old President Viktor Yanukovich told investors shortly before the signing. The highest end of expectations for Olesska's potential reserves would match around three years of European Union gas demand, but similarly sunny hopes for shale reserves in neighboring Poland have been very sharply downsized. Shale development in Europe is far behind the booming U.S. sector and progress is patchy. Chevron pulled out of a shale exploration tender in Lithuania and has suspended work at a Romanian shale well after local protests. Ukraine Energy Minister Eduart Stavytsky, who signed the deal with Chevron executive Derek Magness, set it in the context of a high price Ukraine pays Russia for its gas. "This is one more step towards achieving full energy independence for the state. This will bring cheaper gas prices and the sort of just prices which exist (elsewhere) in the world," he said.
Samstag, 22. Februar 2014
Adam Feuerstein in not a Analyst or anything else ***Adam Feuerstein mybe an expert of Beer and Wine and ( animal ) Dog research but he knows nothing about Biotech he receive his articles from ( John Tucker )!!! Adam hides behind armor of being a Journalist. he is the servant of the Hedge Fund devils that play the retail investors daily ** Adam Feuerstein is absolutely a tool of the short sellers in biotech. everything he writes comes from them he scare Investors with his Lie´s with his article based on no background later he came out with ethical aspect and more more garbage ** fact is Adam Feuerstein is a paid writer !** clinical data is often difficult for physicians to interpret, much less layman like Adam Feuerstein ** Adam Feuerstein write this at 10/18/13 - 08:29 AM ,Investors have fallen in love with orphan drug stocks this year because the business model prints money. Aegerion Pharmaceuticals (AEGR_), Alexion Pharmaceuticals (ALXN_), NPS Pharmaceuticals (NPSP_) and others develop drugs for serious and rare diseases afflicting small numbers of patients. In exchange for spending the time and money to develop drugs for diseases that might ordinarily be ignored, these companies get to charge sky-high prices -- $400,000 or more in some cases. Insurance companies generally pick up the tab without complaints because there are so few patients who need these expensive drugs !! *** also he is Bashing about these companies but on the other side he Pump $BMRN because Jim Cramer pumping every Time Biomarin read more *** By: Adam Feuerstein | 02/18/14 - 09:30 AM EST BioMarin Pharmaceuticals (BMRN) is pricing its latest orphan disease drug Vimizim at $380,000 per year, including discounts, the company announced Tuesday. The FDA approved Vimizim on Friday for the treatment of Morquio A Syndrome, a very rare genetic disorder which causes problems with bone development, growth and mobility. BioMarin has identified approximately 1,500 Morquio A patients worldwide, with about 15% of them in the U.S.*** in this article no bad word about this expensive drug $380.000 a year and Biomarin $BMRN why ???? *** who can pay that is my question ???? read more ** insider call them the Bermuda Triangle ** Adam Feuerstein & Short Trading corp ( Hedge Found ) & The Street( Plattform ) ** here is another example a self called analyst Adam Feuerstein !! He came out with a article last year from a 25 years old study from a family drugmaker is in "race" to get 3,4-Dap approved before $CPRX -- Jacobus study says it's only in phase II the last 25 years !! ( It won't be hard to find out why it's only in Phase II despite 25 year history !! ) only to remember nothing is for Free !! on goin Phase 2 Study's are not for Free !!! Jacobus need about 25 - 28 Million Dollar for the Phase 2 & Phase 3 Study's !! Study's from Jacobus says their compound is not safe !! this is one of the BIG reason why they are 25 year in Phase 1 b- 2 ! Jacobus received some time WARNING Letters from FDA !! FDA planed to re visit Jacobus 2014 but it BURN *** However **** The FDA personnel carry and periodically employ Geiger counters during their manufacturing facility inspections at Jacobus Pharma *** Firdapse is a Approved drug In Europe and in sales ** Catalyst Pharmaceuticals Partners licensed the North American rights from Biomarin's drug for LEMS *** The FDA granted Firdapse for Orphan drug Status !! Firdapse is in Phase 3 *** Orphan drug status means 7 Years of exclusivity rights *** the growing sales from every quarter from Firdapse from Biomarin $BMRN speak for itself ** Firdapse will be Approved in U.S soon ** Reframing the Catalyst-Jacobus Debate Following up on the recent brushfire debate on Catalyst (Firdapse) and Jacobus (compounded amifampridine), below we highlight data points that may add valuable perspective to investors focused on the LEMS space as the contemplate the true extent of this “competition.” View from Jacobus: manufacturing in a black box. We recently scheduled a call with Jacobus Pharmaceuticals (private) in order to better understand its business model, clinical plan, regulatory strategy, compounding quality control, manufacturing capability and patient outreach. After having first scheduled a time to speak with us, on further reflection, the company’s management cancelled the call, guiding that relevant and sufficient information about Jacobus is already accessible in the public domain. Following their guidance, we redirected our attention to some of the only available sources of information on Jacobus: FDA inspection reports (Form 483) of the company’s Industrial Research Laboratory Building (Schalks Crossing Road, Plainsboro, NJ) from 2011 and 2012. The reports paint a colorful picture of the equipment, quality control, production, and storage at the Jacobus facility, where Dapsone (leprosy tx) and 4-Aminosalicylic acid USP (tuberculosis tx) are also manufactured. The following are representative observations quoted in the report: (a) “procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed”; (b) “there is failure to thoroughly investigate batches that do not meet specification”; (c) “containers used in the production of drug products are not identified at all times”; (d) “facilities used in the manufacturing and storage of components, API, and in-process materials are inadequate”; (e) “equipment used in manufacturing of drug products are not maintained in a state of repair”. The reports also containSchalks Crossing Road. Constructed by the Industrial Nuclear Reactor Laboratories, a consortium of major companies, the conical dome is 87 feet high and made of 18-inch-thick concrete clad in aluminum. It housed a laboratory for low-level atomic research (emphasis added). The reactor became obsolete and was decontaminated, and ownership reverted to the Walker-Gordon Laboratory Company. Today, it houses the offices of Walker-Gordon and the laboratories of Jacobus Pharmaceuticals. (emphasis added). At this time we are unable to ascertain if and how this could affect more stringent manufacturing quality and safety checks from a regulatory point of view, or whether FDA personnel carry and periodically employ Geiger counters during their manufacturing facility inspections at Jacobus Pharma
Donnerstag, 6. Februar 2014
IsoRay was founded in Richland, Washington in 1998 to develop, manufacture and market isotopes for use in the medical treatment of various malignant diseases. Company founders included recognized experts in the medical isotope field, including Lane A. Bray, chief chemist of IsoRay, who developed the patented process for economically separating and purifying Cesium-131. In March 2003 IsoRay received clearance to market Cesium-131 from the Food and Drug Administration (FDA) for the treatment of prostate, breast, liver, brain, head and neck cancers and other malignant disease. In October of 2004, a patient was first treated with Cesium-131 at the University of Washington Medical Center. Beginning more than 40 years ago, Cesium-131 was the first choice over other radioactive medical isotopes, although scientific and economic considerations prevented its development. Once these hurdles were overcome, IsoRay was formed to bring the new treatment tool to market. Treating different types of cancer using Cesium-131 is only the first step for IsoRay. Management expects to broaden it's product offering with the development of protocols for the treatment of all types of crippling malignancies. positive results in treating brain cancers, meningioma tumors, pelvic wall, lung cancer, colon cancer, gynecologic cancer and prostate cancer with our Cesium-131 product line University of California San Diego and John Muir Medical Center Initiated Treating Patients for Colon and Lung Cancer Utilizing IsoRay's Cesium-131 Seeded Mesh IsoRay CEO Dwight Babcock noted, "We are extremely encouraged by the number of new facilities taking notice of the successes achieved by other major cancer centers when Cesium-131 is made available to their patients. We are excited to have the University of California and John Muir Medical Center as our newest thought leaders utilizing Cesium-131 products for newly diagnosed and recurrent cancers where other treatments have previously failed. Currently all of our studies in multiple medical centers are performing well with positive results in treating brain cancers, meningioma tumors, pelvic wall, lung cancer, colon cancer, gynecologic cancer and prostate cancer with our Cesium-131 product line. We are making a difference in thousands of lives by providing new ideas and solutions in the battle against cancer and we believe Cesium-131 is the isotope of the future." IsoRay's Cesium-131 sutured seeds, stranded mesh and the GliaSite® radiation therapy system each give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of brain tumor removal. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy brain and lung tissue as well as critical structures compared to other alternative treatments. IsoRay's cancer fighting products reduce the ability of the tumor to recur, which means important benefits for patients in longevity as well as quality of life IsoRay's Cesium-131 Sutured Seeds in Treating Metastatic Brain Cancer IsoRay's neurosurgical applications utilizing Cesium-131 sutured seeds, stranded mesh and the GliaSite® radiation therapy system each give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of brain tumor removal. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy brain tissue as well as critical structures compared to other alternative treatments. IsoRay's cancer fighting products reduce the ability of the tumor to recur, which means important benefits for patients in longevity as well as quality of life. IsoRay is the exclusive manufacturer of Cesium-131. Cesium-131 is the first new isotope to be available in seed form for brachytherapy in approximately 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation). In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh, and several new implantable devices. IsoRay also distributes the GliaSite® radiation therapy system, used to treat brain cancers. leaders and medical centers throughout the US. Excerpts from the abstracts presented at ASTRO can be seen below. Note in the following studies, all show Cesium-131's effectiveness in treating tumors compared to other common treatments. Cesium-131 seeds, sutured seeds or mesh were placed within the resected tumor bed at the time of surgery to provide immediate radiation therapy to it and to a margin depth of 5 mm which is dosed to prevent tumor recurrence. Resection Cavity Dynamics Following Implantation of Cesium-131(Cs-131) Brachytherapy for Resection Brain Metastases Based on CT-Planning M. Yondorf, L. Nedialkova, B. Parashar, D. Nori, K. Chao, J. Boockvar, S. Pannullo, P. Stieg, T. Schwartz, and A. Wernicke; Weill Cornell Medical College, New York, NY Purpose/Objective(s): Velocity of tumor shrinkage is one of the factors that correlate with incidence of radiation necrosis (RN), with rapid shrinkage causing significant irradiation of surrounding brain tissue that originally outside the target volume. Our institution has reported the effective use of intra-operative application of Cs-131 brachytherapy for patients with newly diagnosed brain metastases with 0% of clinical RN as compared to I-125 which causes RN 0-26%. In this study, we prospectively assess the resection cavity dynamics with the goal of determining the dose distribution over time and its potential impact on RN. Conclusions: Resection cavity shrinkage demonstrated in this study over time is negligible, thus potentially explaining 0% incidence of clinical RN in this patient population. Our results are supported by the literature which indicates that no statistically significant volume change occurs up to 33 days after surgery for most patients (Atalar et al). This potentially explains why the short t1/2 of Cs-131 makes an ideal radioisotope as compared to I-125 where resection cavity shrinkage may be of consequence as it only delivers 90% of its intended dose in a 200 day period. Dosimetric Comparison of Cs-131 Versus I-125 Intraoperative Brachytherapy for Patients With Resected Brain Metastasis Renders Cs-131 More Sparing of Normal Brain Tissue: Clinical Relevance for Prevention of Radiation Necrosis From a Prospective Trial L. Nedialkova,1 A. Sabbas,1 S. Trichter,1 F. Kulidzhanov,1 B. Parashar,2 D. Nori,2 K. Chao,2 M. Yondorf,2 and A. Wernicke2; 1New York Presbyterian Hospital - Weill Cornell Medical Center, New York, NY, 2Weill Cornell Medical College, New York, NY Purpose/Objective(s): Cs-131 has significant advantages to I-125 due to its higher dose rate and shorter half life (T 1/2). I-125 implant has been reported in the literature to cause up to 26% incidence of radiation necrosis (RN). This study examines the dosimetric differences between the two radio-isotopes when used as a permanent implant for patients with resected brain metastasis. Conclusions: In this analysis, we report that Cs-131 exposes less normal brain tissue to radiation, thus providing a dosimetric superiority and subjecting less tissue to RN. Further, with a median follow-up of 10 months, all 24 patients have 100% clinical local control while experiencing 0% incidence of RN. Interim Results of a Prospective Phase 2 Trial of Pelvic IMRT, Cesium-131 Brachytherapy Boost, Adjuvant Docetaxel Chemotherapy, and Long-term Androgen Ablation for Patients With High-Risk Prostate Cancer Y. Kwok, M. Ferris, M. Moshe, R. Kataria, and C. Nickerson; University of Maryland Medical Center, Baltimore, MD Purpose/Objective(s): Despite aggressive therapy more than 50% of patients with high-risk prostate cancer fail biochemically. We instituted a phase II protocol which attempts to improve on these results by adding a brachytherapy boost, designed to further increase the prostate dose and docetaxel to address possible systemic disease. The following describes the interim results of patients who have been off of all therapy. Conclusions: This aggressive, multi-modal therapy incorporating Cs-131 brachytherapy for high risk prostate cancer is well-tolerated and produces encouraging disease control. Longer follow-up is needed to assess whether these results are maintained. Temporal Changes in MRI Edema and Resection Cavity Dynamics Subsequent to Implantation of Cesium-131 (Cs-131) Brachytherapy in Patients With Brain Metastases: A Volumetric Analysis From a Prospective Study S.P. Lazow, M. Yondorf, I. Kovanlikaya, D. Nori, K. Chao, J. Boockvar, S. Pannullo, P. Stieg, T. Schwartz, and A. Wernicke; Weill Cornell Medical College of Cornell University/New York Presbyterian Hospital, New York, NY Purpose/Objective(s): Our institution has previously reported the effective use of intra-operative application of Cs-131 brachytherapy for patients with newly diagnosed brain metastases. In this study, we prospectively assess edema and resection cavity dynamics using volumetric analysis of MRI scans following application of Cs-131. Conclusions: In this study, there is minimal resection cavity shrinkage, and the cavity volume change is not statistically significant even over an extended follow-up period of a median 80 days. This analysis has additionally demonstrated a statistically significant reduction in edema volume between the first post-operative MRI and subsequent MRI scans. Based upon this prospective analysis, there is significant reduction in edema following Cs-131 implantation that is evident at a median 41 days after surgery and maintained throughout the median 80-day follow-up period. Comparison of Wedge Resection Versus Wedge Resection Plus Cesium-131 Brachytherapy Versus Stereotactic Body Radiation Therapy in Management of Early Stage Lung Cancer Patients That Are Not Candidates for a Standard Lobectomy B. Parashar,1 S. Arora,1 P. Christos,2 J. Port,3 A. Wernicke,1 D. Nori,1 and K. Chao1; 1Stich Radiation Center, Weill Cornell Medical Center, NY, 2Division of Biostatistics and Epidemiology, Weill Cornell Medical Center, NY, 3Department of Cardiothoracic Surgery, Weill Cornell Medical Center, NY Purpose/Objective(s): Treatment options for early stage non-small cell lung cancer (NSCLC) for patients that cannot undergo lobectomy includes wedge resection (WR), WR plus brachytherapy (WRB) or stereotactic body radiation therapy (SBRT). The purpose of the study was to compare the outcomes for the three treatment options. Conclusions: Cs131 brachytherapy added to wedge resection significantly improves LC compared to wedge resection alone in early stage NSCLC patients not undergoing lobectomy. Cs131 and SBRT are equivalent and wedge resection alone is inferior in terms of LC. A prospective study comparing the three options is indicated for a final answer regarding the best treatment option for this challenging disease. Permanent Interstitial Radiation With Cs-131 Implants for Gynecologic Malignancies: Analysis and Results of an Initial 13 Applications C.E. Wooten, M.E. Randall, P. Aryal, and J. Feddock; University of Kentucky, Lexington, KY Purpose/Objective(s): Interstitial brachytherapy is an ideal, yet underutilized, treatment modality for small volume gynecological malignancies, especially in circumstances where higher doses of radiation are needed while respecting normal tissue toxicity. Our institution has extensive experience using Au-198 radioactive sources for interstitial brachytherapy. We recently performed the first interstitial implant for a gynecologic malignancy using a newer isotope, Cs-131, which has a more favorable dosimetric profile. This report reviews our initial experience with the Cs-131 radioactive isotope for gynecological patients. Conclusions: Our series is the first and only to report on clinical outcomes following Cs-131 permanent interstitial implants for gynecologic malignancies. We conclude that Cs-131 seeds are effective in achieving durable local control for small volume gynecologic malignancies. IsoRay CEO Dwight Babcock says these presentations are just the latest evidence in support of Cesium-131 as a safe and effective treatment of cancerous tumors. These successful studies are what will drive patients and physicians to use Cesium-131 as we continue to promote the Company's pioneering Cesium-131 brachytherapy seeds and liquid isotopes throughout the body. "We continue to advance our domestic and international strategy of creating widespread awareness and adoption of Cesium-131 in hopes that these experiences will ultimately become a standard of care. The exceptional results that have been realized in treating such a wide array of cancers are drawing an increasing number of inquiries from the medical community. We believe Cesium-131's ability to fight cancer and improve the quality of life for the men, women, and children who are battling these devastating cancers distinguishes it from other treatment options." IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation). In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh, and several new implantable devices.
Samstag, 1. Februar 2014
*IsoRay has a FDA approved therapy with a 98% cure rate for the deadliest form of Brain Cancer ! IsoRay stay not more longer under $ 1 * IsoRay $ISR got the only FDA approved therapy for the deadliest form of Brain Cancer, Glioblastoma Multiforme! *IsoRay's products have a 98% cure rate for cancer IsoRay have no Approved Competitor in this Area !! http://www.isoray.com *IsoRay is the exclusive manufacturer of Cesium-131. Cesium-131 is the first new isotope to be available in seed form and now in liquid for brachytherapy in approximately 20 years *** Cesium-131 has a half-life of 9,7 days, compared to a half-life of 17 days and 60 days for Palladium-103 and Iodine-125, respectively. A shorter half-life means faster dose delivery, that cancer cells have less opportunity to repopulate, and less protracted radiation to normal healthy tissues. The energy emitted by Cesium-131 is stronger than Iodine-125 and Palladium-103 (29 KeV vs. 28 KeV and 21 KeV, respectively). Because the energy is stronger, fewer radioactive seeds are required. This reduces risk of urinary reactions following implantation. "Cesium-131 brachytherapy is nothing less than a new standard of care for treatment of prostate cancer, giving patients an improved quality of life and peace of mind *** *IsoRay have a strong patent portfolio * . On January 7, 2014, IsoRay, Inc. (the "Company"), issued a press release announcing the Company's receipt of 510(k) approval from the FDA to market Cesitrex� (liquid Cs-131) with the GliaSite� radiation therapy system *Cesium-131 is FDA-cleared in seed form for the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. *It has received the CE mark enabling them to sell and distribute their GliaSite RTS in 31 European countries. *FDA Cleared IsoRay's Liquid Cesium (Cesitrex) for Use With GliaSite in Treating Glioblastomas and Metastatic Brain Cancers *Growing sales team and new Area Sales Director new 8k : Jan 17 .2014 http://biz.yahoo.com/e/140108/cprx8-k.html *IsoRay $ISR projected Sales 10 X higher than current Market Cap !! * Head and Neck: 52,540 new cases annually (2000 cases x $119 x 25 seeds = $5,950,000) * Lung: 222,520 new cases annually (4000 cases x $119 x 40 seeds = $19,040,000) * Prostate: 217,730 new cases annually (13,000 cases x $72 asp x 85 seeds = $79,560,000) * Ocular Melanoma: 2,480 new cases annually (200 cases x $119 x 15 seeds = $350,000) * Breast: 209,000 new cases annually (10,000 cases x $199 x 40 seeds = $47,600,000) * Colon: 102,900 new cases annually (5,000 cases x $199 x 40 seeds = $23,800,000) The FDA and the EU have both approved their "GliaSite" product. I believe somebody posted earlier that they charge $10K per GliaSite balloon catheter used in the treatment of brain cancer. (Note, I haven't seen the numbers yet on their latest Cesium-131 liquid product which was just approved by the FDA.) Estimated revenues as a function of the number of cases for each type of brain cancer is shown below: * Brain (primary, metastasis & meningioma): 22,020, 150,000 & 10,000 new cases annually respectively (Primary(GBM): ~2,000 cases x $10k = $20,000,000) (Metastasis : ~15,000 cases x $10k = $150,000,000) (Meningioma : ~500 cases x $10k = $5,000,000) TOTAL PROJECTED REVENUES: $351,300,000 IsoRay $ISR is an ideal Buyout candidate. Some of the big Pharma companies such as Merck (MRK), Bristol-Myers Squibb (BMY), and Pfizer (PFE) and Johnson & Johnson (JNJ) could really benefit from Isoray's products have a 98% cure rate for cancer
Donnerstag, 30. Januar 2014
Cesium 131 is probably the biggest advancement in 20 years in low-dose radiation therapy and brachytherapy. We have submitted for publication our five-year results. In prostate alone our five-year history shows we've achieved 100% success with low-risk prostate cancer and 98% success at five years for low and intermediate risk patients. These results are superior to any other low-dose radiation isotope or any other modality such as prostatectomy (cutting the entire prostate out) and/or external radiation therapy. A 98% to 100% cure rate for prostate cancer is phenomenal. The cure rate for a prostatectomy or external beam radiotherapy is about 89%, and the side effects are horrendous. With Isoray's technology, the side effects are short-lived and minimal. Patients have literally played golf the day following the procedure. FDA approved !! Isoray have a strong patent portfolio.On January 7, 2014, IsoRay, Inc. (the "Company"), issued a press release announcing the Company's receipt of 510(k) approval from the FDA to market Cesitrex� (liquid Cs-131) with the GliaSite� radiation therapy system. /// Isoray have no Approved Competitor in this Area !! http://www.isoray.com *IsoRay is the exclusive manufacturer of Cesium-131. Cesium-131 is the first new isotope to be available in seed form and now in liquid for brachytherapy in approximately 20 years *Cesium-131 is FDA-cleared in seed form for the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. *It has received the CE mark enabling them to sell and distribute their GliaSite RTS in 31 European countries. *FDA Cleared IsoRay's Liquid Cesium (Cesitrex) for Use With GliaSite in Treating Glioblastomas and Metastatic Brain Cancers *Growing sales team and new Area Sales Director new 8k : Jan 17 .2014 http://biz.yahoo.c Isoray is an ideal buyout candidate. Some of the big Pharma companies such as Merck (MRK), Bristol-Myers Squibb (BMY), and Pfizer (PFE) and Johnson & Johnson (JNJ) could really benefit from Isoray's products. A 98% to 100% cure rate for prostate cancer is phenomenal. The cure rate for a prostatectomy or external beam radiotherapy is about 89%, and the side effects are horrendous. With Isoray's technology, the side effects are minimal. Patients have literally played golf the day following the procedure. Brachytherapy involves the precise placement of radiation sources directly at the site of the cancerous tumor, as opposed to to EBRT (external beam radiotherapy) in which high-energy x-rays are directed at the tumor from outside the body, killing good cells along the way. An important feature of brachytherapy is that the irradiation only affects a very localized area around the radiation sources. Exposure to radiation of healthy tissues further away from the sources is reduced, so there is less collateral damage. Also, if the patient moves or if there is any movement of the tumor within the body during treatment, the radiation sources retain their correct position in relation to the tumor. These characteristics of brachytherapy provide advantages over EBRT - the tumor can be treated with very high doses of localized radiation, while reducing the probability of damaging healthy tissues around the tumor. A course of brachytherapy can be completed in less time than other radiotherapy techniques. This can help reduce the chance of surviving cancer cells dividing and growing in the intervals between each radiotherapy dose. With brachytherapy, the procedure is done once, typically on an outpatient basis, whereas with external beam radiotherapy, patients need to return every day for 30 to 45 days in order to receive treatment. Brachytherapy makes treatment accessible and convenient and enables most patients to tolerate the procedure very well. Isoray takes brachytherapy to a whole new level by using its patented Cesium 131 seeds or liquid as the radiation source. This offers many advantages over the traditional iodine and palladium radiation isotopes. These two isotopes both have lower energy than Cesium 131 and have a much longer half-life. In other words, Cesium 131 delivers its dose much more rapidly to the cancer site than the others do. Cesium half-life is only 9.7 days whereas iodine's half-life is 59 days. Isoray improves a person's ability to receive the cancer killing agent much more rapidly and then have it become inert much sooner in the body. Because of iodine's long half-life, it is common for a patient to experience side effects six months to nine months after the treatment, whereas with Cesium 131, the side effects are minimal and disappear within 60 to 90 days. For patients, that's a huge improvement. Another important fact is that Medicare and private insurance cover Isoray's products so it has no limitations in receiving reimbursement. Isoray offers the type of solution Obama Care needs in offering a lower cost alternative with superior results for the patient. Those of us who have been involved in biotech companies know that reimbursement can make or break a company. After achieving success in the prostate cancer area, Isoray, is now marketing products into other areas as well, including lung, head and neck, brain, eye, and colon cancer, and is developing solutions for breast and esophagus cancer. Isoray has a big advantage in these new markets because in many cases it will be calling on the same physicians the sales reps already know from the prostate market. This expansion into new areas will provide the revenue growth that will drive Isoray to profitability