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OncoTEX, Sterling Pharma Sign Clinical Mfg. Pact

Sterling will produce clinical material for OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

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By: Kristin Brooks

Managing Editor, Contract Pharma

OncoTEX Inc., an oncology company of the iQ Group Global, and Sterling Pharma Solutions, a global CDMO, signed a clinical development agreement for the manufacture of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.
 
Sterling will produce clinical material in its cGMP facility in Germantown, WI, which has the capabilities to handle highly potent active pharmaceutical ingredients (HPAPIs) in fully contained manufacturing suites.
 
OxaliTEX is the first candidate to emerge in a new class of oncology drugs that are tumor localizing, well-tolerated, and overcome platinum-resistance, as well as being MRI-detectable, allowing clinicians and patients to easily monitor tumor regression during treatment. It has been developed by OncoTEX using its oncology drug platform, TEX Core, to address the urgent, unmet clinical need in ovarian cancer diagnosis and treatment.
 
“The challenges involved in the manufacture of this complex molecule was a perfect fit for the expertise and capabilities that our team in Germantown have,” said Dr Andrew Henderson, Chief Commercial Officer at Sterling Pharma Solutions. “We have worked closely with the OncoTEX team to identify a suitable development and manufacturing strategy, and we look forward to continuing our partnership with them throughout the process to ensure the greatest chance of advancing this new therapy through clinical development.”

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