14th October, 2015: Piramal Enterprises' Pharma Solutions division, a global leader in contract development and manufacturing (CDMO), has delivered its comprehensive review of the injectables market – both sterile and small molecule – for the next 5 years during its CPhI annual report piece.
A representative from Coldstream Laboratories, a Piramal Enterprises business, will be attending InformEx 2015 in New Orleans, LA. The event will take place at the Morial Convention Center February 3 - 5, 2015.
Mumbai, 16th January, 2015: Piramal Enterprises Limited (‘PEL’, NSE: PEL, BSE: 500302) today announced that it has invested USD 30.65 million towards acquiring Coldstream Laboratories Inc. (‘Coldstream’), through its wholly owned subsidiary in the USA in an all cash transaction. Of this, USD 5.65 million would be towards the purchase of the facility building which is currently leased to Coldstream, while the rest would be towards purchase of 100% of the company’s shares. Coldstream is a Contract Development and Manufacturing Organisation (CDMO) focused on the development and manufacturing of sterile injectable products.
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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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 firstname.lastname@example.org
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.
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).
Adrian Raiche, Ph.D. Named as Director of Formulation Development at Coldstream Laboratories, Inc.