Navigation Links
CEL-SCI Completes Validation of Manufacturing Facility Allowing It To Commence Manufacturing of Multikine
Date:1/11/2010

VIENNA, Va., Jan. 11 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE 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.((TM)) 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 www.cel-sci.com.

When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K/A for the year ended September 30, 2008. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SOURCE CEL-SCI Corporation

RELATED LINKS
http://www.cel-sci.com/

'/>"/>

SOURCE CEL-SCI Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CEL-SCI Retains Global Contract Research Organization to Manage Upcoming Phase III Clinical Trial for Its Cancer Drug Multikine
2. CEL-SCI Corporation Releases Letter to Shareholders
3. CEL-SCI Hires Clinical Research Organization for Clinical Study With Hospitalized H1N1-Infected Patients
4. CEL-SCI Expands H1N1 Flu Virus Work
5. CEL-SCI to Present Data from Multikine Clinical Trials at National Institutes of Health (NIH), National Cancer Institute (NCI) Seminar Series
6. CEL-SCI Posts New Corporate Presentation to Website
7. CEL-SCI Corporation Releases Letter to Shareholders
8. CEL-SCI Corporation Releases Letter to Shareholders
9. CEL-SCI Announces Expansion of Exclusive Licensing Agreement for Cancer Drug Multikine
10. CEL-SCI Enters Agreement With National Institutes of Health Clinical Center To Determine the Molecular Basis of Multikine Anti-Tumor Effect
11. CEL-SCI Expects to Take Delivery of New Manufacturing Facility on October 8, 2008
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... --   , Study met ... cleansing and superiority in , Excellent ... of the ascending colon   , ... Norgine B.V. today announced new positive data from the phase III ... versus standard 2 litre PEG with ascorbate. The study met both ...
(Date:5/24/2016)... Zealand , May 24, 2016 ... informatics solutions for the healthcare sector, has been named the ... Zealand Hi-Tech Awards 2016. Dr Bruce Davey ... acknowledgement for our team.  It,s really good to be recognised ... healthcare internationally. Our products are used in 35 countries around ...
(Date:5/24/2016)... , May 24, 2016 Celsion ... drug development company, today provided an update on ... escalating clinical trial combining GEN-1, the Company,s DNA-based ... treatment of newly-diagnosed patients with advanced ovarian cancer ... debulking surgery.  GEN-1 is an IL-12 DNA plasmid ...
Breaking Medicine Technology:
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... Southland ... line of classic American timber frame barn kits, which can be found on its ... inspired by historic American barn plans, and they highlight the craftsmanship of timber post ...
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent of acute stroke survivors ... sustainable product to aid in the rehabilitation process has steadily increased. Ekso Bionics had ... with hemiplegia due to stroke. , Ekso Bionics has now received clearance from the ...
(Date:5/27/2016)... ... May 27, 2016 , ... Beleza Medspa has initiated a new ... This is the first time that Coolsculpting is being used for for more than ... to ensure they meet the prescribed body-fat standard, measured by the circumference-based tape method. ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team of ... food industries. Aside from its GMP accreditation, Validation Center is also a registered ... products, services and staff. , Validation Center is ISO17025 accredited and only offers ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cabot Corporation, Pfizer, and ... according to court documents and SEC filings. A jury has returned a ... American Optical Corporation, Case No. BC588866, Los Angeles County, California. The jury awarded ...
Breaking Medicine News(10 mins):