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Coldstream Laboratories Partners with CytImmune for Phase II Sterile Manufacturing

 
LEXINGTON, Ky., Sept. 16, 2014 (GLOBE NEWSWIRE) --Coldstream Laboratories, Inc. a provider of sterile drug product development and manufacturing services, has announced a partnership with CytImmune to manufacture CYT-6091 for injection in preparation for Phase II clinical trials.  CYT-6091 is part of CytImmune's Aurimune platform.  Specifically, Coldstream shall perform scale-up and optimization of the manufacturing and lyophilization process to enable the manufacture of clinical trial materials.

CYT-6091 is comprised of gold nanoparticles bound with an immune-avoiding component (PEG-Thiol) and tumor necrosis factor alpha (TNF) which has been successfully tested at the National Cancer Institute, Bethesda, Maryland, in a Phase I clinical trial in advanced-stage cancer patients. As seen in that study, the gold nanoparticles were observed to accumulate in tumor tissues while leaving healthy tissue unaffected. The Aurimune platform provides a significantly enhanced safety profile for TNF when formulated as CYT-6091 compared to systemically administered TNF.

The Phase II trials, to be conducted in New York City at Montefiore Einstein Center for Cancer Care will scale production tenfold from Phase I manufacturing. The study will be designed to test how well CYT-6091 benefits lung cancer patients.

Dr. Lawrence Tamarkin, CytImmune’s CEO said, “We have seen proven success of CYT-6091 in Phase I clinical trials. We are looking forward to partnering with Coldstream in preparation for Phase II trials in an effort to move cancer care forward.”

Coldstream’s President & CEO, Eric W. Smart, added, “We are extremely pleased that CytImmune has chosen Coldstream as their CMO. We are confident that the encouraging results from CYT-6091 trials paired with Coldstream’s parenteral manufacturing expertise will lead to a successful relationship and improve treatments available to cancer patients.”
 
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About CytImmune
CytImmune is a clinical stage nanomedicine company with a core focus on the discovery, development and commercialization of multifunctional, tumor-targeted cancer therapies. Based on a research and development strategy to harness the unique properties of gold nanoparticles, cytotoxic agents, and biology of tumors, CytImmune is developing a pipeline of proprietary drug candidates by binding potent anti-cancer agents – whose toxicity profiles currently prevent or severely limit clinical use – to its patented tumor-targeting platform nanotechnology. The company's nanomedicine technology is highly versatile and may be used with a broad spectrum of anti-cancer agents. For more information on CytImmune, please visit www.cytimmune.com.

About Coldstream Laboratories
Coldstream Laboratories, Inc., based in Lexington, KY, is a privately held specialty pharmaceutical contract manufacturing organization, also offering full analytical, formulation, microbiology and lyophilization development services. Coldstream specializes in the development and manufacture of highly potent compounds and operates Kentucky’s only parenteral manufacturing facility. For more information, visit www.coldstreamlabs.com or email customerservice@coldstreamlabs.com 
















Coldstream Expands Business Development Group

 
jdwinell

LEXINGTON, KY--Coldstream Laboratories, Inc., a provider of parenteral manufacturing and sterile drug product development services, announced that Jason Dwinell has joined the Business Development Group in the role of Business Development Manager.  In this position, Mr. Dwinell will primarily represent the territory west of the Rocky Mountains.

Coldstream Laboratories Completes Successful FDA Inspection

 

LEXINGTON, KY., Apr 21, 2014 (GLOBE NEWSWIRE) --Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced the completion of a successful inspection by the Food and Drug Administration (FDA). Coldstream hosted FDA authorities from April 8 – 17, 2014, at its manufacturing facility in Lexington, KY. The site audit reviewed quality systems to ensure compliance with current Good Manufacturing Practices (cGMPs).  

Coldstream Laboratories Third-Time Winner of CMO Leadership Award

 
parenteral contract manufacturing
LEXINGTON, KY (April 10, 2014)  Coldstream Laboratories, Inc., a provider of sterile drug product development and parenteral manufacturing services is a winner of Life Science Leader’s annual CMO Leadership Awards for the third consecutive year. 

The CMO Leadership Awards are presented by Life Science Leader magazine and were developed to assist pharmaceutical and biotech companies in identifying reliable and reputable contract manufacturing partners.  All research and results are compiled by Nice Insight, with voters being those organizations seeking CMO services.  The official award website states:

Coldstream Announces Key Quality Certifications for Team Members

 

LEXINGTON, KY--(Marketwired – February 5, 2014) - Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced certifications for four key members of its Quality Assurance Team.

Coldstream Laboratories Names Director of Formulation Development

 

Adrian Raiche, Ph.D. Named as Director of Formulation Development at Coldstream Laboratories, Inc.

Coldstream to Exhibit at World ADC Conference

 
antibody drug conjugates

Coldstream and Goodwin Biotechnology will co-exhibit at the World ADC Summit in San Francisco, CA, from October 14th to 17th.  Please meet us at Booth #13 to discuss your cytotoxic antibody drug conjugation needs.

Coldstream Laboratories Awarded 5-Year Contract With the National Cancer Institute

 

LEXINGTON, KY--(Marketwired - Sep 24, 2013) - Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced that they have been awarded a 5-year contract with the National Cancer Institute ("NCI") under solicitation number N02CM37007-11 (contract# HHSN261201300031I) entitled "Development and Production of Parenteral Dosage Forms for Clinical Studies."

Coldstream Laboratories Expands Business Development Group

 
sterile manufacturing

Pamela Savoy Added as Director of Business Development at Coldstream Laboratories, Inc.

Coldstream to Attend Generics Conference

 

Christopher A. Verbicky, Ph.D., MBA, will be attending the “6th Product and Pipeline Enhancement for Generics Conference” in this week in Washington, D.C.  The event will take place at the Sheraton Crystal City Hotel July 23 – 25, 2013.

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