Healthcare Industry News: HSMN NewsFeed
News Release - May 8, 2019
ReNeuron Provides Business Update and Results NotificationSecond Cohort of Phase 2a Study in Retinitis Pigmentosa Dosing Complete
LONDON, May 8, 2019 -- (Healthcare Sales & Marketing Network) -- ReNeuron Group plc (AIM: RENE), a global leader in the development of cell-based therapeutics, announced a year-end business update ahead of its preliminary results for the year ended March 31, 2019, which will be announced on Thursday, July 11, 2019.
"We are greatly encouraged by the progress we have made with our cell therapy clinical development programs for retinitis pigmentosa (RP) and stroke disability since our interim financial results update last December. Both the hRPC and CTX studies are expected to continue to yield meaningful clinical data during the course of 2019 and 2020. We are pleased to be working with Fosun Pharma as our partner for China and are encouraged by the level of interest other potential collaborators are showing in all of our programs. We look forward to continuing to advance our clinical and business development activities in the months ahead," said Olav Hellebų, Chief Executive Officer of ReNeuron.
Recent Highlights from Clinical Programs
hRPC for Retinal Disease
ReNeuron has made significant progress advancing the clinical development of the Company's human retinal progenitor cell (hRPC) therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP). Most recently, on April 26, 2019, the Company reported positive preliminary data in the first cohort of the Phase 2a part of its study of hRPC in RP. All three subjects in the cohort demonstrated a rapid and sustained improvement in vision compared with their pre-treatment baseline. Dosing of the second cohort in the study is now complete. The second cohort comprised three patients with a greater baseline level of visual acuity than those patients earlier in the study. The clinical protocol for the study allows for up to 12 patients (four cohorts of three patients each) to be treated in the Phase 2a part of the study. The Company expects to treat the final six patients of the study this summer and to report data from all 12 of the Phase 2a subjects in the second half of this calendar year. These results will form the basis of the Company's interactions with the European and US regulatory authorities regarding the remaining clinical development path of hRPC for the treatment of RP. ReNeuron's RP clinical programme benefits from Orphan Drug Designation in both Europe and the U.S., as well as Fast Track designation from the U.S. Food and Drug Administration (FDA).
CTX for stroke disability
ReNeuron is continuing to progress the clinical development of its CTX cell therapy candidate for stroke disability. In January 2019, the Company announced that patient dosing had commenced in PISCES III, a randomised, placebo-controlled, Phase 2b clinical trial in 110 patients at up to 40 clinical trial sites in the U.S.
ReNeuron is currently evaluating the optimum global development plan for the CTX cell therapy candidate for stroke disability. Subject to relevant regulatory approvals, the ongoing PISCES III study may be expanded to include clinical sites in China. On April 9, 2019, the Company announced the signing of an exclusive licence agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma") for the development, manufacture and commercialisation of ReNeuron's CTX and hRPC cell therapy programs in the People's Republic of China. Potential expansion of the PISCES III study into China would be conducted in conjunction with Fosun Pharma.
Subject to finalization of the clinical development plan for CTX, and based on current patient recruitment and resource planning, ReNeuron expects to report top-line data from the PISCES III study during the second half of 2020, later than the original guidance of early 2020. The Company expects the PISCES III clinical trial, if positive, to be one of two pivotal studies required to support marketing authorisations for CTX in stroke disability.
ReNeuron is pursuing opportunities to capitalise on the significant scientific and life sciences industry interest in exosomes by forming near-term, value-generating, business partnerships covering the Company's exosome technology. ExoPr0, the first CTX-derived exosome candidate arising from this technology, is being developed as a novel vector for delivering third party biological drugs. In January 2019, ReNeuron signed a collaboration agreement with a US-based biopharmaceutical company to explore the use of the Company's exosome technology to create delivery vehicles for synthetic oligonucleotides used in gene therapy. ReNeuron is in active discussions with other commercial third parties regarding potential collaboration agreements for the Company's exosome technology. Business Development Activities
ReNeuron's technologies and therapeutic programs have increasingly attracted the interest of commercial third parties, as demonstrated by the Company's recent licence agreement with Fosun Pharma. The Company is in discussions with other commercial third parties regarding potential collaboration and/or out-licensing deals across ReNeuron's programs.
ReNeuron's unaudited financial results for the year ended March 31, 2019 remain in line with the Board's previous expectations.
The Company had unaudited cash, cash equivalents and bank deposits totalling £26.39 million as of March 31, 2019 (March 31, 2018 audited: £37.41 million). The Directors expect that the Company's current financial resources, combined with the £6.0 million upfront fee and near-term milestone income from the above-mentioned licence agreement with Fosun Pharma, will be sufficient to support operations for at least the next 12 months from the date of this announcement.
Notification of Preliminary Results
ReNeuron will announce its preliminary results for the year ended March 31, 2019 on Thursday, July 11, 2019. A meeting for analysts will be held at 10.00am BST (5:00 a.m. ET) on the morning of the announcement, at the offices of Buchanan, 107 Cheapside, London EC2V 6DN. Further details regarding the analyst meeting will be announced in due course.
ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off-the-shelf' stem cell treatments, without the need for immunosuppressive drugs. The Company's lead clinical-stage candidates are in development for disability as a result of stroke and for the blindness-causing disease, retinitis pigmentosa. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.
This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.
Source: ReNeuron Group
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