April 28, 2008
Rockville, MD— Today CytImmune Sciences, Inc. CEO, Dr. Lawrence Tamarkin and UMBI Vice President for Research, Innovation and Commercialization, Dr. Theodore Roumel, officially signed a multiphase agreement for process development and manufacturing of CytImmune’s AuriTol (CYT-21001) at UMBI’s new GMP Biomanufacturing Facility in Rockville, Maryland. Development of clinical grade material is a key part of CytImmune’s drug development plans for its Phase I clinical trial of the second-in-a-family of colloidal gold-based nanomedicines. This agreement represents the first major deployment of the new state-of-the-art facility for clinical trial material development and manufacture.
"We are very pleased and excited to have this opportunity to work with CytImmune in the development and manufacture of their cuttingedge tumor-targeting nanotherapies. It is the mission of UMBI and the GMP Training and Biomanufacturing Program to enhance the economic development of Maryland Biotech, and this agreement with CytImmune is another step in support of this important goal", said Dr. Daniel Kuebbing, Director of UMBI’s GMP Training and Biomanufacturing Program.
The agreement was formalized at a signing ceremony at 2:00 pm today in room 2129 of the CARB II Building at UMBI’s Shady Grove Campus, located at 9600 Gudelsky Drive in Rockville, Maryland. Key UMBI and CytImmune staff were part of the signing ceremony.
Many of the key products produced by CytImmune are based on nanotechnology, which involves precise synthesis of materials on this nanometer (1 billionth of a meter) scale. CytImmune’s patented technology is based on colloidal gold particles that carry specific drugs to targets such as cancer cells. The particles allow the drugs to be safely transported through the blood stream and directed to their specific cellular targets. The technology to produce the colloidal gold nanoparticles and the fully formulated nanomedicine will be transferred to UMBI for GMP manufacture.
”Having a GMP facility right here in Maryland will enable us to work through potential scale-up challenges quickly and efficiently, with the goal of producing sufficient drug for clinical testing”, said Dr. Tamarkin.
The GMP Program meets the standards required by the FDA for production of clinical grade materials. The GMP Program is a contract manufacturing operation within UMBI, which is the biotechnology institution of the University System of Maryland. The 6,000 squarefoot GMP Facility is available to commercial, government and academic clients, and can simultaneously support two separate manufacturing processes. It has the capabilities to produce biological products under CGMP regulations for toxicology studies or Phase I / II clinical trials. For more information on the GMP facility and program, please contact Daniel Kuebbing, the director of the program, by telephone at (240) 314-6350, or by email at email@example.com
With research centers in Baltimore, Rockville, and College Park, UMBI, the University of Maryland Biotechnology Institute, is the newest of 13 institutions forming the University System of Maryland. UMBI has more than 60 ladder-ranked faculty and a mandate to advance the biotechnology economy while preparing a well-equipped workforce. Celebrating more than 20 years of service to Maryland and the world, UMBI is led by microbiologist and former biotechnology executive Dr. Jennie C. Hunter-Cevera. For more information visit www.umbi.umd.edu.
CytImmune Sciences is a clinical stage nanomedicine company with a core focus on the discovery, development and commercialization of multifunctional, tumor-targeted therapies. CytImmune traces its roots back to TAP, UMCP, where as an incubator company, it focused on diagnostic, research products. From the sales of research products, Federal and State grants, and equity financing the Company refocused its efforts to cancer therapeutics, having just completed a Phase I trial of its first novel cancer nanomedicine, with multiple Phase II combination trials planned. Housed in Montgomery County, the Company will manufacture its second-in-a-family of nanomedicines at UMBI’s cGMP production facility. www.cytImmune.com
Source: CytImmune Sciences