CEL-SCI CORP. DL-01 (WKN: 871006)
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VIENNA, Va., Jan. 11 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM), a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today it has completed the validation of all critical utilities and manufacturing equipment at its GMP manufacturing facility in Maryland. Completion of this validation effort represents a very important milestone as it allows CEL-SCI to move forward with its drug manufacturing plans for the investigational cancer drug Multikine® for the upcoming head and neck Phase III clinical trial. The manufacturing facility is now also ready to offer Contract Manufacturing services which could commence following the manufacture of Multikine.
"Reaching this validation milestone represents a major step forward for CEL-SCI, as it will allow the Company to produce the drug necessary for our pivotal global Phase III clinical trial," said Geert Kersten, CEO of CEL-SCI. "We believe that having our own facility gives us greater control over the Multikine manufacturing process and helps increase the probability of Multikine becoming an approved drug."
The Phase III clinical trial with Multikine will focus on advanced primary head and neck cancer patients. It will enroll approximately 800 patients in about 11 countries around the world and will evaluate Multikine's ability to increase the overall survival of treated patients when used in conjunction with the current standard of care treatment.
The clinical need is great as treatment prospects for these patients have not improved much over the past decades, the market is very large and since CEL-SCI has all of the major marketing rights, the potential is very significant. Head and neck cancer represents about 6% of all of the world's cancer.
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve patients' overall survival by 33% over what can be attained with standard treatment alone (without the addition of Multikine therapy) at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for this Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients having squamous cell carcinoma (cancer) of the head and neck.
About Multikine
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS". Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received surgery, chemotherapy and/or radiation therapy, which can limit their effectiveness.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing an immunotherapy to treat H1N1 hospitalized patients using its L.E.A.P.S.â„¢ technology platform. This investigational treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit http://www.cel-sci.com/.
http://www.finanznachrichten.de/...-and-commercial-operations-008.htm
CEL-SCI Hires Vice President of Manufacturing/Facilities and Commercial Operations
VIENNA, Va., Jan. 15 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX: CVM), a late-stage oncology company and a developer of vaccines and therapeutics for the treatment of infectious diseases, announced today the appointment of Todd S. Burkhart as Vice President of Manufacturing/Facilities and Commercial Operations for its manufacturing facility. Mr. Burkhart has over 30 years of experience in the manufacture and process development of biologicals, medical devices and other Active Pharmaceutical Ingredients (APIs). During his distinguished career in the Pharmaceutical and Biopharmaceutical Industry and prior to joining CEL-SCI, Mr. Burkhart has been responsible for all aspects of GMP manufacturing and operations, including production, materials controls and facilities maintenance. In addition he has extensive experience in the design of manufacturing facilities meeting FDA GMP requirements. Mr. Burkhart has also been involved in the building and/or running a number of major pharmaceutical facilities at companies such as Cephalon, Human Genome Sciences and Univax Biologics.
Geert Kersten, Chief Executive Officer of CEL-SCI, said: "We are pleased to have been able to attract to our team such an accomplished executive, with deep experience and expertise in all facets of the manufacturing process for biologics and other drugs. This hire represents another step CEL-SCI has taken in order to increase the likelihood of a successful outcome of its global pivotal Phase III study of Multikine® for the treatment of head and neck cancer."
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global pivotal Phase III clinical trial in advanced primary head and neck cancer. CEL-SCI is also developing an immunotherapy to treat H1N1 hospitalized patients using its L.E.A.P.S. technology platform. This investigational treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This unique investigational treatment is currently being tested in a clinical study at The Johns Hopkins University Hospital. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit http://www.cel-sci.com/.
CEL-SCI Corporation
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Web Site: http://www.cel-sci.com/
© 2010 PR Newswire
http://biomedreports.com/articles/most-popular/...cs-nasdaq-agen.html
Schon 10% hoch und gutes Volumen.
Hier dürfte bald die Post abgehen!
Viel Erfolg!
nun bestätigt
weißt du mehr
mfg
http://www.mysmartrend.com/news-briefs/...ullish-engulfing-pattern-ce
und noch aktuelle news
http://www.businesswire.com/portal/site/home/...06452&newsLang=en
An sich ist die Celi ein verlässlicher Wert, da nicht otc gehandelt. Liegt wahrscheinlich ein bischen daran, aber wenn endlich news zu deren FDA Freigaben kommen, wird hier die Post dermaßen abgehen, dass ein hinterherkommen nur mit deutlichen Aufschlägen möglich sein wird.
Meine Meinung, keine Empfehlung.
http://www.finanznachrichten.de/...ii-clinical-trial-of-multi-004.htm
CEL-SCI Corporation Receives Approval from North Mississippi Health Services' Institutional Review Board to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer
CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received approval from the North Mississippi Health Services ("North Mississippi") Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare.
CEL-SCI's Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. North Mississippi is the first site in the United States to approve enrollment of subjects. CEL-SCI's trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. CEL-SCI plans to announce additional site approvals and country approvals as they become known.
Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
About North Mississippi Health Services
North Mississippi Health Services (NMHS) is a diversified regional health care organization, which serves 24 counties in north Mississippi and northwest Alabama from headquarters in Tupelo, Mississippi. The NMHS organization covers a broad range of acute diagnostic and therapeutic services, offered through North Mississippi Medical Center in Tupelo; a community hospital system with locations in Eupora, Iuka, Pontotoc, West Point, Miss. and Hamilton, Alabama, North Mississippi Medical Clinics, a regional network of more than 30 primary and specialty clinics; and nursing homes. NMHS has an IRB that meets monthly. The NMHS IRB members include doctors, nurses, pharmacists, social workers, a lawyer, risk manager, and community members. This group reviews the science and ethics of the research. Their objective is to assess the risks and benefits to subjects involved in the study. The NMHS IRB has the authority to approve, require modification to, or disapprove all research activities that involve an NMHS investigator, facility, or patient group. Following initial approval, the IRB conducts periodic reviews of such research. In most instances, in order to approve research, an IRB must determine that specified criteria have been satisfied. Among these criteria, an IRB must determine that, when appropriate, the research protocol includes "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. A pivotal Phase III clinical trial with Multikine in head and neck cancer is expected to start in the second half of 2010.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
Contacts:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
© 2010 Business Wire
http://www.finanznachrichten.de/...ii-clinical-trial-of-multi-004.htm
Wäre ja wirklich erfreulich, wenn hier mal was gehen sollte.
Es geschehen ja vielleicht wirklich noch Zeichen und Wunder und der Aktionär hat sich mal nicht geirrt.
Gruss
Vienna, VA, September 27, 2010 -- CEL-SCI Corporation (NYSE AMEX: CVM)announced today it has received approval from the Ethical Council Affiliated with the Ministry of Healthcare and Social Development of the Russian Federation ("Ethical Council") for the Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI expects to have three clinical centers in Russia, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is a major cancer in Russia.
CEL-SCI's Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.
CEL-SCI's trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.
Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
www.cel-sci.com
http://www.finanznachrichten.de/...ne-in-head-and-neck-cancer-004.htm