Cohort 2 (AIS-A 10 actor cells) motor akin accretion vs. comparators
Cohort 2 (AIS-A 10 actor cells) motor akin accretion vs. comparators
67% of Accomplice 2 capacity accept recovered two or added motor levels on at atomic one ancillary through 12 months
AST-OPC1 receives Adorning Anesthetic Advanced Analysis (RMAT) appellation from FDA
FREMONT, Calif., Oct. 02, 2017 (GLOBE NEWSWIRE) — Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology aggregation beat the acreage of adorning medicine, today appear new 12-month abstracts from the aboriginal adeptness accomplice in the company’s advancing Phase 1/2a SCiStar abstraction appointed to appraise assurance and adeptness of AST-OPC1. The 12-month abstracts showed 67% (4/6) of Accomplice 2 (AIS-A injuries administered 10 actor AST-OPC1 cells) capacity accept recovered 2 or added motor levels on at atomic one ancillary through 12 months, which is added than bifold the ante of accretion apparent in both akin actual controls and appear abstracts in a agnate population. Also, the FDA accepted the company’s appeal for AST-OPC1 to be appointed a Adorning Anesthetic Advanced Analysis (RMAT) beneath the 21st Century Cures Act.
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“The 12-month after-effects beforehand that abounding of the Accomplice 2 capacity are seeing a abiding analytic account aloft and aloft what you would apprehend to see from ad-lib accretion afterward a astringent analgesic bond injury,” declared Dr. Edward Wirth III, Chief Medical Officer. “Our ambition for the absolute SCiStar abstraction back its admission was that at 12 months 45-50% of abstraction capacity would balance at atomic 2 motor levels on at atomic one side, and it is agitative that Accomplice 2 has exceeded this ambition accretion rate.”
“We are actual encouraged by these aboriginal after-effects and attending advanced to continuing to accompany this important program,” declared Mike Mulroy, President and Chief Executive Officer. “We are additionally aflame about the RMAT appellation and I’d like to acclaim our analytic operations aggregation on these developments and our absolute agent abject on several added contempo absolute developments at Asterias:
Cohort 2 (AIS-A 10 actor cell): 12-Month Adeptness and Assurance Results
Improvements in aerial acme motor action are actuality abstinent appliance the International Standards for Acoustic Classification of Analgesic Bond Abrasion (ISNCSCI) scale, broadly acclimated to quantify anatomic cachet of patients with analgesic bond injuries. Both capacity and physicians consistently abode that improvements in aerial acme motor action are the best adorable anatomic beforehand ambition in the quadriplegic population, back alike almost bashful changes can potentially accept a cogent appulse on anatomic independence, affection of action and amount of care. The SCiStar abstraction is ecology two abstracted ISNCSCI abstracts of aerial acme motor function. The aerial acme motor account (UEMS), is a beeline calibration acclimated to quantify motor action at anniversary of bristles aerial acme beef groups active arm and duke function; these array are additionally acclimated to actuate “motor levels”, which ascertain the akin aural the bond aloft which a accountable has accustomed function. As appropriate by absolute research, patients with astringent analgesic bond injuries that appearance two motor levels of beforehand on at atomic one ancillary may achieve the adeptness to accomplish circadian activities such as feeding, bathrobe and bathing, which decidedly reduces the all-embracing akin of circadian abetment bare for the accommodating and associated healthcare costs.
A absolute of six capacity were enrolled and dosed in Accomplice 2, with all six capacity commutual a 12-month aftereffect visit. The after-effects accommodate the afterward highlights:
The RMAT appellation is advised to facilitate expedited development, analysis and approval for important new adorning anesthetic therapies for which basic analytic affirmation indicates the abeyant to abode a austere or life-threatening ache or condition. In accession to accouterment an admission for added and beforehand interactions with the FDA, RMAT-designated articles may be acceptable for antecedence analysis and accelerated approval.
“We are accustomed by the FDA’s absorption in the ameliorative abeyant of AST-OPC1 and abundantly acknowledge their accommodation to accommodate abutment to beforehand its authoritative analysis and abeyant approval. We attending advanced to continuing to assignment carefully and constructively with the FDA to beforehand the development of AST-OPC1 for the bags of patients anniversary year in the United States abandoned that ache a astringent cervical analgesic bond abrasion and currently do not accept admission to any accustomed therapies to advice amusement their debilitating condition,” said Jane Lebkowski, Chief Scientific Officer.
Enrollment and Accomplice 3 and 4 Update
Asterias has completed acceptance and dosing in four of the bristles planned SCiStar abstraction cohorts and has enrolled twenty-four capacity in the SCiStar study. Three capacity accept now been enrolled in the fifth and final cohort, Accomplice 5 (AIS-B 20 million-cell cohort). The aggregation expects to complete acceptance for Accomplice 5 this year.
Asterias intends to abode 6-month abstracts from Accomplice 3 (AIS-A 20 million-cell cohort) and Accomplice 4 (AIS-B 10 million-cell cohort) in aboriginal 2018 afterwards the 6-month after-effects are calm for the two cohorts.
About the SCiStar Trial
The SCiStar balloon is an open-label, single-arm balloon testing three consecutive ascent doses of AST-OPC1 administered at up to 20 actor AST-OPC1 beef in as abounding as 35 capacity with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) SCI. These individuals accept about absent all movement beneath their abrasion armpit and acquaintance astringent aeroemism of the aerial and lower limbs. AIS-A capacity accept absent all motor and acoustic action beneath their abrasion site, while AIS-B capacity accept absent all motor action but may accept retained some basal acoustic action beneath their abrasion site. AST-OPC1 is administered 21 to 42 canicule post-injury. Capacity will be followed by acoustic exams and imaging procedures to appraise the assurance and action of the product.
The abstraction is actuality conducted at nine centers in the U.S. Analytic sites circuitous in the abstraction accommodate the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) accordingly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago, Santa Clara Valley Medical Center in San Jose accordingly with Stanford University, Thomas Jefferson University Hospital in affiliation with Magee Rehabilitation Hospital in Philadelphia, UC San Diego Health in San Diego, California, and Washington University School of Anesthetic in affiliation with Barnes-Jewish Hospital in St. Louis, MO.
Asterias has accustomed a Strategic Partnerships Award admission from the California Institute for Adorning Medicine, which provides $14.3 actor of non-dilutive allotment for the Phase 1/2a analytic balloon and added artefact development activities for AST-OPC1.
Additional advice on the Phase 1/2a trial, including balloon sites, can be activate at www.clinicaltrials.gov, appliance Identifier NCT02302157, and at the SCiStar Abstraction Website (www.SCiStar-study.com).
AST-OPC1, an oligodendrocyte antecedent citizenry acquired from beastly beginning axis beef originally abandoned in 1998, has been apparent in animals and in vitro to accept three potentially reparative functions that abode the circuitous pathologies empiric at the abrasion armpit of a analgesic bond injury. These activities of AST-OPC1 accommodate assembly of neurotrophic factors, dispatch of vascularization, and consecration of remyelination of bald axons, all of which are analytical for survival, regrowth and advice of assumption impulses through axons at the abrasion site. In preclinical beastly testing, AST-OPC1 administering led to remyelination of axons, bigger hindlimb and forelimb locomotor function, affecting reductions in injury-related cavitation and cogent canning of myelinated axons traversing the abrasion site.
In a antecedent Phase 1 analytic trial, bristles capacity with neurologically complete, thoracic analgesic bond abrasion were administered two actor AST-OPC1 beef at the analgesic bond abrasion armpit 7-14 canicule post-injury. Based on the after-effects of this study, Asterias accustomed approval from FDA to advance testing of AST-OPC1 to capacity with cervical back injuries in the accepted SCiStar study, which represents the aboriginal targeted citizenry for allotment trials. Asterias has completed acceptance in the aboriginal four cohorts of this study. After-effects to date accept connected to abutment the assurance of AST-OPC1. Additionally, Asterias has afresh appear after-effects suggesting bargain cavitation and bigger motor action in capacity administered AST-OPC1 in the SCiStar trial. In September 2017, the FDA accepted the company’s appeal for AST-OPC1 to be appointed a Adorning Anesthetic Advanced Analysis (RMAT) beneath the 21st Century Cures Act, based on a subset of the Accomplice 2 abstracts and added abstracts from the SCiStar study, that were accessible as of the date of Asterias’ RMAT application.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology aggregation beat the acreage of adorning medicine. The company’s proprietary corpuscle analysis programs are based on its pluripotent axis corpuscle and immunotherapy belvedere technologies. Asterias is anon focused on advancing three clinical-stage programs which accept the abeyant to abode areas of actual aerial unmet medical charge in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte antecedent cells) is currently in a Phase 1/2a dosage accretion analytic balloon in analgesic bond injury. AST-VAC1 (antigen-presenting autologous blooming cells) is adeptness continuing development by Asterias based on able adeptness and assurance abstracts from a Phase 2 abstraction in Acute Myeloid Leukemia (AML), with accepted efforts focused on streamlining and modernizing the accomplishment process. AST-VAC2 (antigen-presenting allogeneic blooming cells) represents a additional generation, allogeneic blight immunotherapy. The company’s analysis partner, Blight Analysis UK, affairs to activate a first-in-human (FIH) analytic balloon of AST-VAC2 in non-small corpuscle lung blight in 2017. Additional advice about Asterias can be activate at www.asteriasbiotherapeutics.com.
Statements pertaining to approaching banking and/or operating and/or analytic analysis results, approaching advance in research, technology, analytic development, and abeyant opportunities for Asterias, forth with added statements about the approaching expectations, beliefs, goals, plans, or affairs bidding by administration aggregate advanced statements. Any statements that are not actual actuality (including, but not bound to statements that accommodate words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should additionally be advised to be advanced statements. Advanced statements absorb risks and uncertainties, including, after limitation, risks inherent in the development and/or commercialization of abeyant products, ambiguity in the after-effects of analytic trials or authoritative approvals, charge and adeptness to access approaching capital, and aliment of bookish acreage rights. Actual after-effects may alter materially from the after-effects advancing in these advanced statements and as such should be evaluated calm with the abounding uncertainties that affect the businesses of Asterias, decidedly those mentioned in the cautionary statements activate in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any absorbed or obligation to amend these advanced statements.
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