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NeoStem's PCT subsidiary & ImmunoCellular Therapeutics enter into a manufacturing agreement
Allendale, New Jersey | Wednesday, October 5, 2011, 16:00 Hrs  [IST]

Progenitor Cell Therapy, LLC (PCT), an internationally recognized cell therapy services and development company and a wholly-owned subsidiary of NeoStem, Inc. and ImmunoCellular Therapeutics Ltd, a clinical-stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced that IMUC has retained the services of PCT to serve as the second manufacturing site to produce ICT-107, a dendritic cell-based vaccine targeting multiple tumour associated antigens for glioblastoma, for its phase II clinical trial.

As part of this agreement, PCT will transfer and qualify the cGMP manufacturing process for ICT-107 at PCT's West Coast facility in Mountain View, California for use in IMUC's US based phase II clinical trial, as well as subsequent manufacturing to support future trials and development efforts.

“We are very excited to enter into this agreement with ImmunoCellular Therapeutics, whose promising products and technologies are designed to harness the power of the immune system to improve the treatment and diagnosis of cancer,” said Robert A Preti, PhD, president and chief scientific officer of PCT. “PCT will offer ImmunoCellular Therapeutics the same expertise and dedicated service it has offered past clients like Dendreon, for whom we were the primary manufacturer for Provenge for more than seven years during its clinical trials.”

“This agreement with PCT represents a major risk mitigation step in conducting our phase II study of ICT-107 by having two manufacturing sites,” said Manish Singh, PhD, president and chief executive officer of IMUC. “PCT has significant experience in developing and manufacturing patient-specific products and capabilities for supporting this manufacturing into phase III and commercialization. PCT's competencies in autologous cell therapies, cell manufacturing, cell processing and delivery make it ideally suited as a manufacturer for ImmunoCellular Therapeutics as we look forward to completing this phase II trial and seek to secure a strategic partner in connection with a future potential phase III trial for ICT-107 and its commercialization.”

“PCT's unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development, with its East and West Coast facilities, result in clients feeling great comfort entrusting their therapeutics to PCT. We foresee meaningful client base growth as therapeutic development companies come to understand the critical importance of the involvement of a skilled manufacturing partner and the cost-effectiveness of that partner possessing the ability to rapidly scale while providing excellent service,” said Dr Robin L Smith, chairman and CEO of NeoStem.

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