Isofol Medical AB announced the latest information on the Phase Ib\/II clinical trial of SP-05. Evaluation at a dose of 500 mg\/m\u00b2 showed a favorable safety profile, numerous cases of tumor shrinkage, and an increased number of patients eligible for surgical intervention. The Phase II will expand sites and participating countries. A concurrent Phase II clinical trial in Japan is also planned. There is no direct impact on fiscal year 2026 results.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"price_fetched_at":"","company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4597","jir_company_name":"Solasia Pharma K.K.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-11-11","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/11\/4597-20261111-01.pdf","jir_short_summary":"Isofol Medical AB announced the latest information on the Phase Ib\/II clinical trial of SP-05. Evaluation at a dose of 500 mg\/m\u00b2 showed a favorable safety profile, numerous cases of tumor shrinkage, and an increased number of patients eligible for surgical intervention. The Phase II will expand sites and participating countries. A concurrent Phase II clinical trial in Japan is also planned. There is no direct impact on fiscal year 2026 results.","jir_summary":"### Key Points of the News\nThis communicates Isofol's latest disclosure regarding the Phase Ib\/II clinical trial of SP-05. Evaluation at 500 mg\/m\u00b2 continues in Phase Ib with no safety concerns observed; many patients demonstrated disease control and tumor shrinkage. Five patients were assessed as candidates for surgical intervention and discontinued from the trial. The recommended dose for Phase II has been determined, and an expansion of facilities and participating countries has been decided. A Phase II trial in Japan is planned to run in parallel. There is no direct impact on fiscal year 2026 financial results.\n\n### Outlook and Impact\nExpanding the facilities and participating countries for Phase II will increase trial opportunities and geographic reach, potentially leading to long-term indication expansion and business opportunities. However, the information in this press release relates to clinical trial progress and does not directly translate into short-term financial metrics. The parallel trial plan in Japan suggests potential future clinical development progress and expansion of business opportunities.","jir_financial_highlights":"Timing of impact: Unknown (Unknown)\nRevenue: Unknown (Unknown)","jir_category":"","jir_hashtags":"#SolasiaPharma, #ClinicalTrial, #SP-05, #DrugDevelopment","jir_key_figures":"Number of patients assessed as candidates for surgical intervention: 5 cases (out of 10 total treated patients)\nApproximate 50% reduction in maximum tumor diameter (assessed based on RECIST 1.1)\nContinued evaluation at a dose of 500 mg\/m\u00b2","jir_meta_title":"Solasia Pharma K.K. SP-05 Clinical Trial Update: Phase II Expansion Plan\uff5cNovember 2026","jir_meta_description":"Solasia Pharma K.K. announces the latest on SP-05 Phase Ib\/II clinical trial. Safety profile is favorable, tumor shrinkage trends observed, and cases eligible for surgical intervention increased. Plans announced to expand Phase II sites and run a concurrent trial in Japan. Financial impact is expected over the mid-to-long term; no direct effect on FY2026 results.","jir_og_title":"Solasia Pharma K.K. SP-05 Clinical Trial Update\uff5cNovember 2026","jir_og_description":"Latest Phase Ib\/II trial updates for SP-05 disclosed in collaboration with Isofol. Safety is favorable, tumor shrinkage confirmed, and an increased number of surgical candidates. Plans for Phase II expansion and a concurrent trial in Japan announced.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":59381,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"business_update","footnotes":""},"sector":[],"importance":[],"class_list":["post-149709","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n