CHR-1103

CHR-1103 is a monoclonal antibody being developed as an acute treatment for relapses (flares) associated with MS. The drug's unique mechanism of action has the potential to reduce the severity and duration of a relapse along with stemming the residual neurological damage that often accompanies a relapse, thereby slowing the overall progression of the disease.

Chromos Molecular Systems Inc. announced today the publication of a paper entitled "Modulation of Experimental Autoimmune Encephalomyelitis by VLA-2 Blockade" in the peer-reviewed scientific journal, Brain Pathology. This paper, authored in collaboration with Dr. Robert Fujinami of the University of Utah School of Medicine, demonstrates that a monoclonal antibody directed against VLA-2, the target for Chromos' lead product candidate CHR-1103, can suppress the clinical and pathological signs of disease in a relevant animal model of multiple sclerosis (MS). In addition, the publication validates VLA-2 as a potential target for early therapeutic intervention in the treatment of MS. This data represents a significant milestone in the development of CHR-1103 as an acute treatment for relapses associated with MS.

"We are very pleased with the release of this data as it represents the culmination of a tremendous body of work in support of the development of CHR-1103 as an acute treatment for MS relapse," said Alistair Duncan, President and CEO. "Currently, there are no FDA approved therapies for MS patients suffering from a relapse. CHR-1103 represents a promising new approach for the treatment of MS relapse and disease compared to the existing portfolio of chronically administered treatments."

CHR-1103 is a humanised monoclonal antibody being developed as a broad-based anti-inflammatory agent, with an initial focus on the treatment of acute relapses associated with MS. Unlike therapeutics designed to delay or antagonise the initial stages of inflammation, CHR-1103 is designed to reduce and prevent the accumulation of inflammatory cells within inflamed tissues. This distinction, i.e., the targeting of ongoing inflammation with CHR-1103, may provide a significant advantage for the acute treatment of inflammatory conditions and/or diseases.

Chromos completed its first meeting with officials from the U.S. Food and Drug Administration (FDA) for CHR-1103 in Q3 2006. The two parties discussed Chromos' clinical approach, proposed preclinical safety evaluation program and manufacture of CHR-1103. Chromos is now moving forward with preclinical safety evaluation studies in preparation for an Investigational New Drug (IND) application in Q4 2007.

Source: Chromos Molecular Systems Inc.(25/01/07)

Members of the Chromos MS Advisory Board are:

- Jack Antel, MD
Professor, Montreal Neurological Institute, McGill University

- Dennis Bourdette, MD
Chairman, Department of Neurology and Director of the MS Center of Oregon, Oregon Health and Sciences University

- James Bowen, MD
Medical Director of the Multiple Sclerosis Center at Evergreen Healthcare, Kirkland, Washington

- Lorne Kastrukoff, MD
Associate Professor, MS Clinic, University of British Columbia, Division of Neurology, Department of Medicine and Brain Research Centre

- Joel Oger, D.en M., FRCPC
Professor, University of British Columbia, Medicine, Pathology and Neurosciences

- Leslie P. Weiner, MD
Professor of Neurology, Keck School of Medicine, University of Southern California

"We are extremely fortunate and delighted to have the participation of this highly respected and experienced group of experts for the development of our lead product, CHR-1103," said Alistair Duncan, President and CEO of Chromos. "The ability to access and rely on such a panel of individuals is a tremendous asset for Chromos as we move forward with the clinical development of CHR-1103 for MS."

CHR-1103 is a monoclonal antibody being developed as an acute treatment for relapses (flares) associated with MS. The drug's unique mechanism of action has the potential to reduce the severity and duration of a relapse along with stemming the residual neurological damage that often accompanies a relapse, thereby slowing the overall progression of the disease.

Chromos has completed a Pre-IND Meeting with the US Food and Drug Administration (FDA) regarding the development of CHR-1103 and anticipates filling an Investigational New Drug (IND) application for CHR-1103 in 2007.

The Chromos MS Advisory Board will be instrumental in guiding the overall clinical development strategy supporting the initial indication for CHR-1103 as an acute treatment for MS relapse, but also follow-on indications surrounding long-term progression of MS and conversion to MS following initial clinical symptoms.

Source: Chromos Molecular Systems Inc.(05/10/06)

Chromos recently completed its first meeting with officials from the U.S. Food and Drug Administration (FDA). The two parties discussed Chromos' clinical approach, proposed preclinical safety evaluation program and manufacture of CHR-1103. Chromos is now moving forward with preclinical safety evaluation studies in preparation for an Investigational New Drug (IND) application in Q3 2007.

Using its proprietary ACE System, Chromos engineered a stable clonal cell line expressing its product, CHR-1103 and transferred it to AppTec for process development, scale up and manufacture. The ACE System demonstrated the ability to perform well in large-scale manufacturing, validating the use of the platform for clinical and commercial scale manufacturing of biopharmaceuticals. The Company is now preparing to begin its preclinical safety evaluation studies with Charles River Laboratories.

Chromos has engaged two leading MS clinicians to act as clinical consultants for its CHR-1103 program. Lily Jung, M.D. is the Medical Director of the Seattle Neuroscience Institute at Swedish Medical Centre in Seattle, WA, and a clinical associate professor in Neurology at the University of Washington Medical School. Mariko Kita, M.D. is a clinical investigator and Director of the Virginia Mason Multiple Sclerosis Center in Seattle, WA. Drs. Jung and Kita will advise and assist with the clinical development of CHR-1103 as it enters clinical trials.

Source: Chromos Molecular Systems Inc. (16/08/06)

Chromos has used its proprietary ACE System to engineer cell lines for CHR-1103; AppTec will scale up and manufacture CHR-1103 for use in preclinical toxicology studies and Phase I clinical trials.

"This contract is an important step forward in the development of CHR-1103," said Alistair Duncan, President and CEO of Chromos. "We are pleased to use our team's proven expertise in cell line engineering with the ACE System to develop our product candidates cost effectively and to work in partnership with AppTec to manufacture this innovative treatment for multiple sclerosis (MS)."

CHR-1103 is one of two drug product candidates gained through Chromos' acquisition of Targeted Molecules Corporation in February 2006. A humanized monoclonal antibody for the treatment of the inflammatory disease, CHR-1103 is being developed initially to treat acute flares associated with relapsing forms of MS. The drug's unique mechanism of action has the potential to reduce the severity of a relapse and stem the residual neurological damage that often accompanies progression of the disease, positioning CHR-1103 to fill an unmet medical need for an effective acute treatment of MS.

Chromos plans to file an Investigational New Drug (IND) application for CHR-1103 in 2007. The Company's second product candidate, CHR-1201, is being developed to treat acute thrombosis and offers the possibility of effective treatment of thrombosis involving the brain without the risk of bleeding.

The ACE System is Chromos' proprietary platform for rapidly generating production-quality cell lines. The ACE System's performance, speed and versatility are key advantages for generating cell lines for research, development and manufacture of biopharmaceuticals.

Chromos and AppTec are strategic partners who offer the biopharmaceutical industry a broad range of cell line engineering and contract manufacturing services. The companies formed a non-exclusive co-marketing agreement in February 2005. They are jointly marketing Chromos' expertise with cell line engineering with its ACE System and AppTec's expertise in scale-up, manufacturing and testing of biopharmaceuticals, offering customers a high-yield, fast-track solution.

About Chromos

Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The Company's lead program, CHR-1103, is a humanized monoclonal antibody being developed as a treatment for acute relapses associated with relapsing forms of MS. Chromos generates revenue from its proprietary platforms - the ACE System and REM technology - to support its drug development programs.

About AppTec

AppTec offers comprehensive testing, contract research and development, and cGMP manufacturing services for biopharmaceuticals, medical devices, cellular therapeutics and tissue-based products from a unique single-source platform. The company has three facilities - St. Paul, MN (also the corporate headquarters); Philadelphia, PA; and Atlanta, GA - all of which are GLP and cGMP compliant and FDA registered. The St. Paul and Atlanta facilities are also ISO certified.

With its 75,000-square-foot, state-of-the-art facility in Philadelphia, AppTec provides integrated, one-stop services for mammalian-cell-culture-based biopharmaceuticals and cellular therapeutics - from complete testing services, to process development and custom manufacturing, including final formulation and fill. Testing services for the biotechnology/biopharmaceutical industries include cell line characterization, viral and process validation, gene therapy vector testing, molecular biology, mycoplasma testing and analytical services.

For medical products, AppTec provides comprehensive biosafety testing including biocompatibility (in vivo and in vitro), chronic toxicity, genotoxicity, microbiology, chemistry, sterilization validation, viral clearance studies, environmental monitoring, and package testing. Contract services include cGMP processing/manufacturing for cells, tissues, and tissue-based products.

The company has 300 employees, seven sales territory offices located across the United States, and a business development office in Europe.

Source: Chromos Molecular Systems Inc.(01/03/06)

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