PCI Biotech receives Orphan Drug Designation in South Korea for fimaporfin in the treatment of bile duct cancer
Oslo, 28 May 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma). No approved treatment alternatives exist today for the first-line treatment of patients with this disease and fimaChem (fimaporfin) has the potential to play a role in this area of high unmet medical need.
“The RELEASE trial has in general shown promise with good recruitment activity in South Korea despite the Covid-19 pandemic. Receiving orphan status from the South Korean authorities is a key step in the development of this important new medicine for Asian cancer patients in need of better local treatments. PCI Biotech’s fimaChem treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods.” said Dr. Per Walday, CEO of PCI Biotech. “Orphan designation in South Korea, in addition to the already granted orphan designations in EU and USA, are all significant regulatory milestones and recognises the therapeutic benefits we seek to bring to the patients.”
Per Walday, CEO
Mobile: +47 917 93 429
About bile duct cancer and the fimaChem technology
The bile duct drains bile from the liver into the small intestine. Bile duct cancer (cholangiocarcinoma) is a cancer that affects the cell lining of the bile duct and represents a patient population with a high unmet medical need. Surgery is the only potential curative option for these patients, but most patients are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. Median survival of inoperable patients is between 11 and 12 months with the current standard of care treatment, which is a chemotherapy combination of gemcitabine and cisplatin. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death, so there is a high need for better locoregional treatments. The locoregional anti-cancer effect of gemcitabine is significantly enhanced by the fimaChem technology in preclinical studies, and early clinical treatment data suggest encouraging tumour response and survival in bile duct cancer patients.
Bile duct cancer is a rare disease with an incidence rate of 1-2 per 100,000 in the western world. The incidence rates are increasing worldwide and are generally higher in Asian countries. The immediate target for PCI Biotech is first-line treatment of inoperable patients with extrahepatic disease. The fimaChem treatment regimen consists of an intravenous injection of fimaporfin, followed four days later by an intravenous infusion of gemcitabine and a laser light application in the bile duct easily administered through endoscopic methods used routinely in these patients. The patients then follow the standard background treatment with up to 8 chemotherapy cycles of gemcitabine + cisplatin. The fimaChem treatment may be repeated during the background chemotherapy treatment cycles.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaChem programme consists of a clinical Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
For further information, please visit: www.pcibiotech.com
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Leading Edge Materials Announces Preliminary Life Cycle Assessment Results on Woxna Graphite Project21.6.2021 15:00:00 CEST | Press release
Vancouver, June 21, 2021 – Leading Edge Materials Corp. (“Leading Edge Materials” or the “Company”) (TSXV: LEM) (Nasdaq First North: LEMSE) (OTCQB: LEMIF) is pleased to announce preliminary Live Cycle Assessment (“LCA”) results for its Woxna Graphite anode project. On December 10, 2020, the Company announced it had commissioned Minviro Ltd. (“Minviro”), a London based globally recognized LCA consultancy, to build an LCA model and deliver a report for the planned vertically integrated production of natural graphite anode material in Sweden as described in the Company’s recently announced Preliminary Economic Assessment (“PEA”) results. The LCA results show that the production of 1 tonne of natural graphite anode material (coated spherical purified graphite (“CSPG”)) from natural graphite extracted at the Woxna Graphite mine is forecast to have an impact of 1.8 tonnes CO2 eq. Minviro applied the same methodology in the report to evaluate current Chinese natural and synthetic graphite ano
Nokia and DISH to deploy first 5G standalone core network in the public cloud with AWS21.6.2021 15:00:00 CEST | Press release
Press Release Nokia and DISH to deploy first 5G standalone core network in the public cloud with AWS Nokia builds on relationship with DISH and AWS as DISH deploys the United States’ first standalone, 5G cloud network on public cloud 21 June 2021 Dallas, Texas – Nokia today said it will deploy its 5G standalone (SA) Core for DISH on Amazon Web Services, Inc. (AWS). While DISH previously announced agreements with both companies, this news marks the world’s first deployment of 5G in the public cloud, supporting DISH’s cloud-native, OpenRAN-based 5G network with high-level scale, performance and security. Nokia is deploying 5G SA Core on AWS to enable automation required to meet evolving customer needs, allowing DISH to support new enterprise and consumer 5G use cases quickly, securely and across multiple cloud stacks at end customer premises. Nokia 5G SA Core on AWS allows DISH to offer the responsiveness, flexibility and efficiency that is needed to create innovative new services for it
Wood Mackenzie Scales Data Analytics Across the Energy Transition by Adding Quinbrook as a Lens Power Development Partner21.6.2021 13:00:00 CEST | Press release
Lens® decision intelligence platform connects the dots across a rapidly changing energy landscape LONDON/HOUSTON/SINGAPORE, June 21, 2021 (GLOBE NEWSWIRE) -- Wood Mackenzie, the leading provider of commercial intelligence for the world’s natural resources sector, today welcomes Quinbrook Infrastructure Partners as a development partner for the industry-leading Lens decision intelligence platform. With its analytics-ready power and renewables data integrated into a single platform, Lens Power enables organisations to maximise investment opportunities in clean energy and be on the forefront of the energy transition. Wood Mackenzie, a Verisk business (Nasdaq:VRSK), is collaborating with early adopters to design a power solution that provides a holistic understanding of what is happening in the world of energy, allowing organisations to analyse, screen and value assets or companies quickly and confidently to improve profitability and minimise risk. Global Power Generation Assets byEnergy S
Rovio Entertainment, Moomin Characters and Gutsy Animations enter into a long-term partnership21.6.2021 12:30:00 CEST | Press release
Rovio Entertainment Corporation Press Release Rovio Entertainment, Moomin Characters and Gutsy Animations enter into a long-term partnership Iconic Finnish brands will join forces to create joyful content for years to come. Rovio becomes an exclusive partner for Moomin based mobile games. ESPOO - Finland, June 21, 2021- Rovio Entertainment Corporation, the creator of Angry Birds, has entered into a long-term partnership with Moomin Characters and Gutsy Animation. Rovio will have the rights to develop and publish Moomin IP based games for any platform, with exclusive rights for all mobile platforms. Rovio will also become a minority shareholder in Gutsy Animations, the creator of the Moominvalley 3D animation series through an equity investment of 2.5 million euros and a convertible loan of 2.5 million euros. Moomin has a very high brand awareness particularly in Japan, which is one of the biggest gaming markets in the world. The length of the partnership is six years, with a possible e
Incap Corporation: INCAP’S FACTORIES IN INDIA CONTINUE OPERATIONS WITH REDUCED CAPACITY. INCAP’S PREVIOUSLY ANNOUNCED OUTLOOK FOR 2021 REMAINS UNCHANGED.21.6.2021 11:30:00 CEST | Press release
Incap Corporation 21 June 2021 at 12:30 p.m. (EEST) Stock Exchange Release Insider information INCAP’SFACTORIES IN INDIACONTINUE OPERATIONS WITH REDUCED CAPACITY. INCAP’S PREVIOUSLY ANNOUNCED OUTLOOK FOR 2021 REMAINS UNCHANGED. Karnataka state continues the fight against the coronavirus pandemic extending the measures taken to limit for instance social gatherings. The lock-down in Karnataka has been extended until 5 July 2021. However, the state government has given a number of concessions indicating a phased opening up in the coming weeks. Incap’s permission to operate its factories is still in force and the company continues to operate with somewhat reduced capacity following the government guidelines. The closure and the partial operations of the factories in India do not have an impact on the company’s outlook for 2021 published on 21 April 2021. Incap’s previously announced outlook for 2021: Incap estimates that its revenue, operating profit (EBIT) and adjusted operating profit (E
Progress on Brunel share buyback program 202121.6.2021 11:00:00 CEST | Press release
Amsterdam, 21 June 2021 – Brunel International N.V. (Brunel; BRNL), reports the transaction details for the period 14 June 2021 through 18 June 2021 related to its share buyback program announced on 1 June 2021 for an amount up to EUR 1,977,000, and started on 3 June 2021 in order to meet obligations under its performance share plan for senior management (excluding Board of Directors). Detailed information including all individual transactions can be found on https://www.brunelinternational.net/en/share-buyback-program. DateTotal shares repurchasedAverage purchase priceTotal consideration 14/06/2021 8,286 € 11.6138 € 96,231.95 15/06/2021 14,103 € 11.5806 € 163,321.20 16/06/2021 14,861 € 11.5029 € 170,944.60 17/06/2021 10,184 € 11.3922 € 116,018.16 18/06/2021 12,935 € 11.2274 € 145,226.42 Total60,369€ 11.4586€ 691,742.33 This press release contains inside information as meant in clause 7 of the Market Abuse Regulation. Attachment Press Release Share Buyback 2021 progress
Scientific Beta releases new inflation-friendly indices21.6.2021 10:36:33 CEST | Press release
Press Release - Boston, London, Nice, Paris, Singapore, Tokyo, June 21, 2021 Scientific Beta releases new inflation-friendly indices Equity inflation indices are Scientific Beta’s first suite of macroeconomic factor indices Scientific Beta has announced the release of inflation-friendly indices, the Scientific Beta US Inflation indices, its first suite of macroeconomic factor indices. The inflation indices provide long-term equity performance with additional inflation protection compared to a traditional cap-weighted equity index. These indices correspond to a genuinely important subject for institutional investment, because in the event of inflation they procure a higher asset value (surplus) that could offset the impact of inflation on the revenue needs of future pensioners. This capacity to produce strong conditional performance does not result in a high level of tracking error with respect to the cap-weighted benchmark, like with many indices, and ultimately in poor unconditional p