CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, today provided an update on OPC1, the Companys oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial, the SCiStar Study, for the treatment of acute spinal cord injury (SCI). Lineage reported positive results from the ongoing SCiStar study of OPC1, where the overall safety profile of OPC1 has remained excellent with robust motor recovery in upper extremities maintained through Year 2 patient follow-ups available to date. Additionally, OPC1 manufacturing has been completely transferred to the Companys cGMP manufacturing facility in Israel and manufacturing process improvements are planned to continue throughout 2020. Moreover, Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program around the middle of 2020.
We remain extremely excited about the potential for OPC1 to provide enhanced motor recovery to patients with spinal cord injuries. We are not aware of any other investigative therapy for SCI which has reported as encouraging clinical outcomes as OPC1, particularly with continued improvement beyond 1 year, stated Brian M. Culley, CEO of Lineage Cell Therapeutics. Overall gains in motor function for the population assessed to date have continued, with Year 2 assessments measuring the same or higher than at Year 1. For example, 5 out of 6 Cohort 2 patients have recovered two or more motor levels on at least one side as of their Year 2 visit whereas 4 of 6 patients in this group had recovered two motor levels as of their Year 1 visit. To put these improvements into perspective, a one motor level gain means the ability to move ones arm, which contributes to the ability to feed and clothe oneself or lift and transfer oneself from a wheelchair. These are tremendously meaningful improvements to quality of life and independence. Just as importantly, the overall safety of OPC1 has remained excellent and has been maintained 2 years following administration, as measured by MRIs in patients who have had their Year 2 follow-up visits to date. We look forward to providing further updates on clinical data from SCiStar as patients continue to come in for their scheduled follow up visits.
SCiStar Study Clinical Update
- Overall safety profile of OPC1 to date is excellent for Year 2 follow-ups available to date (21 patients)
- Motor level improvements
- Upper Extremity Motor Score (UEMS)
OPC1 Clinical Program Update
About the SCiStar Clinical Study
The SCiStar Study is an open-label, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in 25 patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had essentially lost all movement below their injury site and experienced severe paralysis of the upper and lower limbs. AIS-A patients had lost all motor and sensory function below their injury site, while AIS-B patients had lost all motor function but may have retained some minimal sensory function below their injury site. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions as measured by upper extremity motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations at 30, 60, 90, 180, 270, and 365 days after injection of OPC1.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial known as SCiStar for the treatment of acute spinal cord injuries. OPCs are naturally-occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. The clinical development of the OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages 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. Lineages 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. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage 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 to planned manufacturing process improvements and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages 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 Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages 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 Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SECs 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.
- Hungarian Spinal Cord Injury Patient - Stem Cell Treatment Experience - May 7th, 2011 [May 7th, 2011]
- Stem cell treatment for Spinal Cord Injury (SCI)-Osama - May 8th, 2011 [May 8th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Juan Carlos Murillo - May 10th, 2011 [May 10th, 2011]
- Spinal Cord Injury patient 10 years after injury after Stem Cell Treatment - May 10th, 2011 [May 10th, 2011]
- Rap Toward a Cure for Spinal Cord Injury - May 11th, 2011 [May 11th, 2011]
- Christopher "Kit" Bond - Spinal Cord Injury Stem Cell Patient - May 20th, 2011 [May 20th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (2) - May 21st, 2011 [May 21st, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (2) - May 22nd, 2011 [May 22nd, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (1) - May 23rd, 2011 [May 23rd, 2011]
- Dogs recover following new treatment for spinal cord injury - June 2nd, 2011 [June 2nd, 2011]
- Spinal Cord Injury Rehabiliation Success Story - June 3rd, 2011 [June 3rd, 2011]
- Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman - June 7th, 2011 [June 7th, 2011]
- Stroke Client Gains Strength and Mobility in North Palm Beach Florida - June 9th, 2011 [June 9th, 2011]
- Spinal Cord Injury Chicago Rehabilitation Lokomat - June 10th, 2011 [June 10th, 2011]
- Spinal Cord Injury Treatment With Stem Cells - June 11th, 2011 [June 11th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Wesley Hixen - June 12th, 2011 [June 12th, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again - June 13th, 2011 [June 13th, 2011]
- David Chen: How would stem-cell therapies work in the treatment of spinal cord injuries? - June 17th, 2011 [June 17th, 2011]
- William Rader MD - Paralyzed Spinal Cord Injury Patient Walks Again - June 29th, 2011 [June 29th, 2011]
- The Spinal Cord Injury Treatment Team - July 4th, 2011 [July 4th, 2011]
- Introduction to the Bioness H200 Hand Rehabilitation System - July 14th, 2011 [July 14th, 2011]
- Organ repair using own stem cells -- brain, heart - Future Health keynote speaker - July 15th, 2011 [July 15th, 2011]
- 2011 Shriners Ride for Kids, Salt Lake City Utah. - July 17th, 2011 [July 17th, 2011]
- Degenerative Disc Disease: C5-C6 c6-C7 Treatment - July 18th, 2011 [July 18th, 2011]
- Rehabilitation Institute of Michigan's 60 Anniversary TV Commercial - July 18th, 2011 [July 18th, 2011]
- California Spinal Cord Injury Attorney: Obtaining damages for lifetime care. - July 19th, 2011 [July 19th, 2011]
- Physical and Mental Adjustments After a Spinal Cord Injury - July 19th, 2011 [July 19th, 2011]
- Comprehensive Inpatient Rehabilitation - July 28th, 2011 [July 28th, 2011]
- SCI Treatment Center at the Claremont Club - July 30th, 2011 [July 30th, 2011]
- Spinal Cord Inury Patient at XCell-Center- M. Hasan - August 5th, 2011 [August 5th, 2011]
- Spinal Cord Inury Patient at XCell-Center- K. Potts - August 6th, 2011 [August 6th, 2011]
- Magee Rehabilitation Hospital Foundation and Toyota 100 Cars for Good - August 13th, 2011 [August 13th, 2011]
- SCI_Celine_French_ifting_her_arms.wmv - September 1st, 2011 [September 1st, 2011]
- New Treatment May Help Paralyzed Patients Move Again By Dr.Zaghloul ahmed - September 1st, 2011 [September 1st, 2011]
- Claire Marsh - Spinal Cord Injury Part One - September 6th, 2011 [September 6th, 2011]
- Coping with spinal cord and traumatic brain injuries - September 10th, 2011 [September 10th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (3) - September 15th, 2011 [September 15th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (1) - September 20th, 2011 [September 20th, 2011]
- Stem cell treatment by Adiva Health Care India after Spinal Cord Injury - September 22nd, 2011 [September 22nd, 2011]
- Spinal Cord Injury Documentary: You Will Never Walk Again, Part 1 - September 24th, 2011 [September 24th, 2011]
- Claire Marsh Returns - Spinal Cord Injury Patient - September 25th, 2011 [September 25th, 2011]
- Spinal Cord Injury: Raising awareness about research and treatment for spinal cord injury - September 26th, 2011 [September 26th, 2011]
- Walking after Spinal Cord injury and Stem Cells - September 27th, 2011 [September 27th, 2011]
- New Treatments for Spinal Cord Injuries - October 10th, 2011 [October 10th, 2011]
- Claire Marsh - Spinal Cord Injury Part Two - Video - October 18th, 2011 [October 18th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- Stem Cells - Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- (Film Trailer) - The Spinal Cord Journey: Stem Cell Therapy Stories of Recovery - Video - November 27th, 2011 [November 27th, 2011]
- Stem Cell Treatment for T-6 Spinal Cord Injury - Video - December 7th, 2011 [December 7th, 2011]
- What is Project Walk Atlanta - Video - December 13th, 2011 [December 13th, 2011]
- Stem Cells Treatment for Spinal Cord Injuries, Successfully Results, Stem Therapy - Video - December 28th, 2011 [December 28th, 2011]
- Stem Cell Therapy for Spinal Cord Injury, India Mumbai - Video - January 6th, 2012 [January 6th, 2012]
- "April Crave", "Project Walk Spinal Cord Injury Recovery" - Video - January 10th, 2012 [January 10th, 2012]
- "Lori Hammond", "Project Walk Spinal Cord Injury Recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Chad C.""spinal cord Injury treatment" "spinal cord injury" "spinal cord injury recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Hugo Rodovalho", "Client Spotlight Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Cecilia V.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Roy R.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Angela", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Joey's Story", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Spinal Cord Injury", "A Story Of One" - Video - January 27th, 2012 [January 27th, 2012]
- Spinal Cord Injuries - The Healing Center Project! - Video - January 28th, 2012 [January 28th, 2012]
- "Crystal H.", "Project Walk Spinal Cord Injury Recovery" - Video - February 3rd, 2012 [February 3rd, 2012]
- "Dave D.", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Brook", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Ashley Vargas", "Project Walk Spinal Cord Injury Recovery" - Video - February 6th, 2012 [February 6th, 2012]
- "Nathan Bayer", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Annette Ross", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Joe Guintu", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Trevor Comeau,"Project Walk Spinal Cord Injury Recovery" - Video - February 9th, 2012 [February 9th, 2012]
- "Kyle Eade, "Project Walk Spinal Cord Injury Recovery" - Video - February 11th, 2012 [February 11th, 2012]
- Velomedix Receives IDE Approval to Evaluate the Use of Rapid Therapeutic Hypothermia in the Management of AMI Patients - February 14th, 2012 [February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Chamber May Open Window for Treating Spine - February 15th, 2012 [February 15th, 2012]
- InVivo Therapeutics’ CEO Frank Reynolds Scheduled to Appear on Fox News First and San Antonio Living - February 17th, 2012 [February 17th, 2012]
- High doses of 'load' slows loss of bone in spinal cord injury - February 17th, 2012 [February 17th, 2012]
- InVivo Therapeutics Announces Pricing of Public Offering of Common Stock - February 17th, 2012 [February 17th, 2012]
- High Doses of Load Slows Bone Loss in Spinal Cord Injury - February 21st, 2012 [February 21st, 2012]
- InVivo Therapeutics Announces Full Exercise of Over-Allotment Option - February 22nd, 2012 [February 22nd, 2012]
- InVivo Therapeutics Announces Net $18.1M In Offering - February 22nd, 2012 [February 22nd, 2012]