Fibrocell Science Announces Plans for Process Development and Manufacturing of Genetically-modified Cell Therapy for Rare

  Fibrocell Science Announces Plans for Process Development and Manufacturing
  of Genetically-modified Cell Therapy for Rare Disease, RDEB

Business Wire

EXTON, Pa. -- May 28, 2014

Fibrocell Science, Inc., (NYSE MKT:FCSC), an autologous cell therapy company
primarily focused on developing first-in-class treatments for rare and serious
skin and connective tissue diseases with high unmet medical needs, announced
today that Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc.
(NASDAQ:NBS), has been engaged by Fibrocell’s collaborator, Intrexon
Corporation (NYSE:XON), to provide production capabilities in the generation
of cell therapies for the rare disease Recessive Dystrophic Epidermolysis
Bullosa (RDEB). Fibrocell’s clinical program for RDEB will utilize PCT’s
manufacturing expertise and resources to implement the production process for
transfer and clinical manufacturing of genetically-modified cell therapies.
The manufacturing services provided by PCT will augment manufacturing capacity
available to Fibrocell through Intrexon, allowing Fibrocell to focus its
internal operations on its pipeline of personalized biologic cell therapies.

“We are excited about the significant progress we are making in advancing the
RDEB program for this priority drug candidate,” said David Pernock, chairman
and chief executive officer of Fibrocell. “This is a strategic decision to
outsource manufacturing and intensify our internal resources on our pipeline
of promising drug candidates, and it gives us manufacturing flexibility for
our RDEB program, upcoming Phase 3 clinical trials, and other future needs.”

“We thank Intrexon and its collaborator Fibrocell, for the trust they have
placed in PCT by choosing us for this work,” said Dr. Robert Preti, Chief
Scientific Officer of NeoStem and PCT, and President of PCT. “We are confident
that PCT’s manufacturing resources, along with our newly established
Engineering and Innovation Center, will help to strengthen and advance the
RDEB program.”

The process development for the RDEB program will integrate Fibrocell’s
Azficel-T Autologous Fibroblast technology with Intrexon Corporation’s
UltraVector^® technology, and represents the first of several drug development
programs from the collaboration of Fibrocell and Intrexon to create
genetically-modified personalized biologics for rare skin and connective
tissue diseases. The engagement with PCT will enable advances in the process
development and manufacturing of genetically-modified personalized biologics
for the RDEB drug development program and could also be extended to allow for
contract manufacturing of other fibroblast cell therapies that are product
candidates of the Fibrocell-Intrexon collaboration.

PCT will begin technology transfer and process development for the RDEB
program immediately to align with the timeline for the Fibrocell/Intrexon RDEB
drug development program, which is on track to present proof of concept data
this year and is expected to advance to Phase I clinical studies in the first
half of 2015.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy company
primarily focused on developing first-in-class treatments for rare and serious
skin and connective tissue diseases with high unmet medical needs. Based on
its proprietary autologous fibroblast technology, Fibrocell is pursuing
breakthrough medical applications of Azficel-T for restrictive burn scarring
and vocal cord scarring. The company’s collaboration with Intrexon Corporation
(NYSE:XON), a leader in synthetic biology, includes using genetically-modified
fibroblasts for treating rare and serious skin and connective tissue diseases
for which there are no currently approved products. For additional
information, visit www.fibrocellscience.com.

About PCT

Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc.
(NASDAQ:NBS), is a leading contract development and manufacturing organization
in the cellular therapy industry. For over 15 years, PCT has provided
pre-clinical and clinical cGMP development and manufacturing services to more
than 100 clients, advancing regenerative medicine product candidates from the
development stage all the way through to human testing. PCT has two
cGMP-compliant, state-of-the art facilities in New Jersey and California to
serve the cell therapy industry and offers manufacturing of cell therapy-based
products, engineering and innovation services, process and product
development, cell and tissue processing, collection and storage, regulatory
consulting, facility design, validation, and due diligence evaluations.
www.pctcelltherapy.com

Safe Harbor Statement

Some of the statements made in this press release are forward-looking
statements. Forward-looking statements include, without limitation, the
ability of Fibrocell to present proof of concept data this year for its RDEB
study and to develop breakthrough therapies for the treatment of skin and
connective tissues diseases. These forward-looking statements are based upon
our current expectations and projections about future events and generally
relate to our plans, objectives and expectations for the development of our
business. Although management believes that the plans and objectives reflected
in or suggested by these forward-looking statements are reasonable, all
forward-looking statements involve risks and uncertainties and actual future
results may be materially different from the plans, objectives and
expectations expressed in this press release. Accordingly, investors should
not place any reliance on forward-looking statements as a prediction of actual
results.

Contact:

Corporate:
Fibrocell Science, Inc.
Gregory Weaver, +1-484-713-6000
SVP & Chief Financial Officer
gweaver@fibrocellscience.com
or
Investor Relations:
S.A. Noonan Communications, LLC
Susan Noonan, +1-212-966-3650
susan@sanoonan.com
 
Press spacebar to pause and continue. Press esc to stop.