Fennec Announces Positive Results From Phase 3 SIOPEL 6 Study on PEDMARK(TM) (sodium thiosulfate) Presented at the 49th Congress of the International Society of Pediatric Oncology (SIOP) 2017 Meeting
- Study met primary endpoint (p=0.0033)
- Significant reduction in cisplatin induced hearing loss without any evidence of tumour protection in patients with Standard Risk Hepatoblastoma (SR-HB)
- Company plans to pursue regulatory approvals with FDA and EMA
RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2017 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, announced today data from its Phase 3 SIOPEL 6 study presented during the late breaker session on Saturday, October 14, 2017 at SIOP 2017 in Washington, DC.
Top Line Efficacy Data
The SIOPEL 6 study met its primary endpoint. The study demonstrated that the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection. Among the 99 evaluable patients, hearing loss occurred in 30/45=67% treated with Cisplatin (Cis) alone and in 20/54=37.0% treated with Cis+STS, corresponding to a relative risk of 0.56(P=0.0033).
Fennec plans to pursue regulatory approval for PEDMARKTM based on the data from the SIOPEL 6 study along with the proof of principle data from COG ACCL0431. STS has received Orphan Drug Designation in the US in this setting and plans to pursue European Market Exclusivity for Pediatric Use upon approval.
"I am absolutely delighted that after 30 years of research we have found a safe way to reduce ototoxicity in children receiving platinum containing chemotherapy," said Penelope Brock, M.D., PhD, International Chair of SIOPEL. "This means that children who are cured from cancer after receiving platinum treatment can look forward to a normal healthy life, fully integrated into society. I believe this marks a new standard of care in pediatric oncology."
The Company also reported top-line data for secondary endpoints Event Free Survival (EFS) and Overall Survival (OS). The combination of Cis+STS was generally well tolerated. With a follow up of 52 months, 3yr EFS is Cis 78.8% and Cis+STS 82.1%; 3yr OS is Cis 92.3% and Cis+STS 98.2%.
"We are very pleased with the results of this study," stated Rosty Raykov, CEO of Fennec. "We would like to thank all the patients and their families who participated in this trial, physicians, the entire SIOPEL 6 team, and Dr. Neuwelt and his research team at OHSU. We believe that if approved PEDMARK would be an important therapy for patients and caregivers where currently there are no treatment options."
Safety and Tolerability
In the study, the results presented showed that treatment was well tolerated and acute toxicity similar and expected between arms. The table below presents the toxicities of the two arms:
SIOP 2017 Presentation
Fennec will provide access to the recording of SIOP 2017 late breaker presentation on the Company's website.
To access the archived recording, visit the Fennec website at www.fennecpharma.com.
SIOPEL 6 is a multi-centre open label randomized phase 3 study evaluating the efficacy of STS in reducing ototoxicity in patients receiving cisplatin monotherapy for standard risk hepatoblastoma. From the beginning of 2007 to the end 2014, 52 sites from 11 countries enrolled 113 evaluable patients. The study is closed to recruitment and all protocol pre-specified IDMC safety reviews are now complete. The primary efficacy hearing endpoint analysis can be performed once patients have reached 3.5 years of age and an audiometry test can be carried out. The SIOPEL 6 study trial was designed with 80% power and a 5% significance level to detect an absolute 25% reduction in the rate of Brock grade greater than or equal to 1 hearing loss with a chi-square test, from a 60% hearing loss in Cis alone arm to a 35% hearing loss in Cis+STS arm. The primary endpoint is the rate of Brock grade greater than or equal to 1 hearing loss determined after the end of treatment at the age of greater than or equal to 3.5 years by pure tone audiometry.
About PEDMARKTM (sodium thiosulfate/STS)
Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe there is estimated that over 7,000 children are diagnosed with local cancers that may receive platinum-based chemotherapy. Localized cancers that receive platinum agents may have overall survival rates of greater than 80% further emphasizing the quality of life after treatment. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. COG ACCL0431 final results were published in the Lancet Oncology.
In May 2017, Fennec announced the launch of a Named Patient Program in Europe. European based Healthcare Professionals can obtain details about STS Named Patient Program by emailing firstname.lastname@example.org.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc., is a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced ototoxicity in pediatric patients. STS has received Orphan Drug Designation in the US in this setting. Fennec has an exclusive license agreement with OHSU for exclusive worldwide license rights to intellectual property directed to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.
Forward looking statements
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
The scientific information discussed in this news release related to PEDMARKTM is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, Health Canada or other regulatory and no conclusions can or should be drawn regarding the safety or effectiveness of such product candidate.
For further information, please contact:
Chief Executive Officer
Fennec Pharmaceuticals Inc.
T: (919) 636-5144
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Fennec Pharmaceuticals via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
VistaJet Partners With Christie's for the Global Tour of The Collection of Peggy and David Rockefeller22.11.2017 11:39 | Pressemelding
The sale will be the most significant philanthropic auction ever presented LONDON, Nov. 22, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, announces today its worldwide sponsorship of the exhibition and tour of The Collection of Peggy and David Rockefeller, the most significant auction entirely dedicated to raising funds for philanthropic causes. The sale, consisting of numerous categories, will be conducted by Christie's, the world's leading art business, and will include a highlights exhibition tour in Hong Kong, London, Los Angeles and New York. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c78fdce7-7651-42a8-a621-14088da2cc86 http://www.globenewswire.com/NewsRoom/AttachmentNg/33af2489-a9a8-4bbe-b5f7-78e4c1f29ca2 http://www.globenewswire.com/NewsRoom/AttachmentNg/a16c2
Nasdaq to Deliver Blockchain e-Voting Solution to Strate22.11.2017 10:00 | Pressemelding
South Africa's central securities depository (CSD) will leverage the solution to improve voting efficiencies and increase shareholder participation in South Africa STOCKHOLM, Sweden and JOHANNESBURG, South Africa, Nov. 22, 2017 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) and Strate (Pty) Ltd, the South African CSD, announced today an agreement for Nasdaq to deliver a new blockchain solution that would bring electronic voting to the South African capital markets. The solution will allow Strate, in conjunction with key stakeholders in the market, to provide general meeting services and give shareholders an easy, user-friendly and secure tool for voting remotely. The solution is based on the successful proof of concept (PoC) developed for Nasdaq's Estonia market. In addition, Strate will contribute to the ongoing market development of e-Voting technology. "We are very excited about our initiative with Nasdaq and what it means for the South African financial markets," said Tan
Oxford Immunotec to Present at the 29th Annual Piper Jaffray Healthcare Conference21.11.2017 15:15 | Pressemelding
OXFORD, United Kingdom and MARLBOROUGH, Mass., Nov. 21, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that Peter Wrighton-Smith, Chief Executive Officer, will present at the 29th Annual Piper Jaffray Healthcare Conference on Tuesday, November 28th, at 12:00 p.m. EST. The conference will be held at the Lotte New York Palace. A live webcast of the presentation will be available online from the investor relations page of the Company's corporate website at www.oxfordimmunotec.com. A webcast replay will be available approximately two hours after the live presentation and will be archived on the website for approximately 90 days. About Oxford Immunotec Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and comme
CrownBio's Translatable FATZO Model Utilized in Eli Lilly's Preclinical Type 2 Diabetes Research Programs21.11.2017 14:00 | Pressemelding
SANTA CLARA, Calif., Nov. 21, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE: ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces the publication of two new papers. These joint publications illustrate the utility of Crown Bioscience's proprietary FATZO model as a model for obesity and type 2 diabetes in preclinical studies. The research conducted by Crown Bioscience, Eli Lilly and Company and Ball State University was published in two PLOS ONE papers: Peterson et al. Glucose dysregulation and response to common anti-diabetic agents in the FATZO/Pco model PLOS One 2017;12 (6):e0179856, https://doi.org/10.1371/journal.pone.0179856 Droz et al. Correlation of disease severity with body weight and high fat diet in the FATZO/Pco model PLOS One 2017;1
OmniComm Systems Signs Letter of Intent to Acquire Certain Assets of Algorithm and its Subsidiary Algorics21.11.2017 14:00 | Pressemelding
Acquisition Will Expand OmniComm's Product Line With Data Analytics and Risk-Based Monitoring Solutions FORT LAUDERDALE, Fla., Nov. 21, 2017 (GLOBE NEWSWIRE) -- OmniComm Systems, Inc. (OTCQX:OMCM), a leading global provider of clinical data management technology, and Algorithm, Inc. and its subsidiaries Algorics Ltd. and Algorithm Informatics Pvt. Ltd. (collectively, "Algorics"), have signed a letter of intent ("LOI"), under which OmniComm will acquire certain assets and assume certain liabilities of Algorics, a provider of clinical analytics solutions and software. By combining forces, the companies expect increased operating efficiency, strengthened traction in the maturing risk-based approach solution area, new marketing opportunities and an expanded portfolio of electronic data capture (EDC) solutions for the global clinical trials industry. The transaction would also provide OmniComm with an office in India, a country of growing importance in t
Port Moresby Stock Exchange (POMSoX) Launches New Nasdaq Trading System21.11.2017 11:31 | Pressemelding
NEW YORK and PORT MORESBY, Papua New Guinea, Nov. 21, 2017 (GLOBE NEWSWIRE) -- Nasdaq Inc. (NASDAQ:NDAQ) and the Port Moresby Stock Exchange (POMSoX) have announced that POMSoX has gone live with the widely deployed Nasdaq Matching Engine that operates on the Nasdaq Financial Framework platform. The launch of the new trading platform is a result of an upgrade from previous Nasdaq trading technology. The new trading engine will handle the trading of equities in the Papua New Guinea market. POMSoX has been a customer of Nasdaq since 1999. "The Nasdaq trading platform will allow significant innovation in terms of market design and market offerings," said Johnson Kalo, a POMSoX board member said. "We believe the platform will provide strong support for future growth in the PNG market and provide new business opportunities in areas such as market data distribution." "We are pleased to continue to support POMSoX, a longstanding Nasdaq customer," said Robert Frojd, Regional Man
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom