Full Press Release Details
CELL THERAPEUTICS RECEIVES CE MARK APPROVAL FOR RENEVIA
clinical trial met its primary endpoint of change in hemifacial volume at six months (p<.001)
CA - September 19, 2019 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage
biotechnology company developing novel cell therapies for unmet medical needs, announced today that Renevia , the
Company's facial aesthetics product, has been granted a Conformit Europ enne
(CE) Mark. Renevia received a Class III classification with an intended use in adults as a resorbable matrix for the delivery
of autologous adipose tissue preparations to restore and/or augment facial volume after subcutaneous fat volume loss for the treatment
of facial lipoatrophy. The CE Mark provides Lineage, or its authorized agent, the authority to market and distribute Renevia
throughout the European Union (EU) and in other countries that recognize the CE Mark.
CE Mark approval for Renevia is an important corporate accomplishment that demonstrates Lineage's ability to generate positive
data from clinical trials and direct a regulatory application through a successful review and registration process. I wish to
congratulate our clinical/regulatory and technical operations teams on achieving this milestone," stated Brian
M. Culley, Chief Executive Officer. "As a next step, our Board of Directors has authorized us to engage a European business
development representative to evaluate and negotiate partnership opportunities for Renevia. In light of our focus on advancing
our three clinical-stage cell therapy programs, we believe it is in the best interests of our shareholders to seek an external
partner with the commercial capabilities and know-how to launch Renevia in the European market and in return, provide Lineage
with non-dilutive capital to support our novel cell therapy programs. We also will continue to invite and explore development
and partnership opportunities for Renevia's underlying hydrogel technology, HyStem , which may hold potential
as a supportive scaffold for cell therapy, including patient-derived organoid culture and bioprinting of new organs."
in combination with autologous adipose tissue, offers a new small-volume treatment for facial lipoatrophy," Mr. Culley continued.
"In Renevia's pivotal trial in Europe, Lineage studied patients with human immunodeficiency virus (HIV) treatment-associated
lipoatrophy, a severe form of lipoatrophy characterized by the pathological loss of body fat from under the skin. Renevia is designed
to mimic the naturally occurring extracellular matrix in the body and provide a 3-D scaffold, which we believe supports effective
adipose tissue transplant, retention, engraftment, and metabolic support. Renevia and Lineage's other HyStem-associated
hydrogel injectable matrices are designed to facilitate the survival and growth of transplanted cells. Data from the pivotal trial
suggest that Renevia may be a stable long-term solution not only for people with HIV-associated lipoatrophy, but also for people
with other forms of facial fat loss, such as those caused by pharmaceuticals or aging. Additionally, Renevia may be able to serve
as a premium alternative to currently available dermal fillers, which we believe account for more than a million procedures
each year in the European facial aesthetics market. Use of Renevia and autologous adipose tissue may have the potential
to create a better, longer-lasting, and more natural outcome than other fillers used alone."
Lineage proceeds with its efforts to evaluate and negotiate partnership opportunities for Renevia, it expects to provide investors
with additional information regarding commercial plans for the program.
Renevia Pivotal Trial
2017, the Company announced that the Renevia pivotal trial in Europe had
met its primary endpoint. The primary endpoint was the change in hemifacial volume at six months in the treated patients compared
to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Treated patients received approximately
5cc of Renevia in each side of the face (hemifacial). On average, treated patients retained approximately 100% of transplanted
volume at six months. Untreated patients had no incremental hemifacial volume after six months. Comparison of the two trial arms
had a statistical p value <.001. All Renevia transplants were well tolerated and there were no device-related serious
adverse events noted in this pivotal trial. As well as meeting the primary endpoint, treated
patients retained an average of 70% of transplanted volume at 12 months and 64% at 18 months.
Lineage Cell Therapeutics, Inc.
Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's
programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With
this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor
cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or
absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune
response to cancer. Lineage's clinical assets include (i) OpRegen , a retinal pigment epithelium transplant therapy
in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed
world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord
injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development
for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company
on Twitter @LineageCell.
cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking
statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "design," "intend,"
"expect," "could," "plan," "potential," "predict," "seek,"
"should," "would," "contemplate," "project," "target," "tend
to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements
relating Lineage's marketing, distribution and commercial plans for Renevia and Hystem. Forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements
to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements
in this press release, including risks and uncertainties inherent in Lineage's business and other risks described in Lineage's
filings with the Securities and Exchange Commission (SEC). Lineage's forward-looking statements are based upon its current
expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are
expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included
under the heading "Risk Factors" in Lineage's periodic reports filed with the SEC, including Lineage's
Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SEC's
website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which
they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by law.
Cell Therapeutics, Inc. IR