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 email@example.com.
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
Perceptyx Named One of America’s Fastest Growing Companies for the 4th Consecutive Year16.8.2018 05:37 | Pressemelding
INC 5000 award recognizes Perceptyx’s continued innovation and partnership with many of the world’s best companies SAN DIEGO, Aug. 15, 2018 (GLOBE NEWSWIRE) -- For the 4th consecutive year, Perceptyx has made the prestigious INC 5000 list of America’s fastest growing private companies. A recognized leader in people analytics, Perceptyx specializes in facilitating organizational change through the strategic use of employee surveys and management consulting. Longtime partners with many of the world's largest organizations, Perceptyx is uniquely capable of delivering insights across heavily distributed organizations with complex hierarchies in a way that’s as unique as an organization’s culture and brand. “We’re proud to be recognized among America’s fastest growing companies again,” says John Borland, Co-founder and CEO of Perceptyx. “We believe that our clients are the real heroes of their organizations. It has been our honor to help so many of the world’s best companies realize their g
Bombardier Establishes Automatic Securities Disposition Plan15.8.2018 22:48 | Pressemelding
Not for distribution to U.S. news wire services or public dissemination in the United States Plan permits sales of vested shares earned by certain senior executives in accordance with predetermined instructions Plan reinforces the incentive effect of performance-based compensation by allowing for the sale of shares on the open market over a period of up to two years at prevailing market prices, regardless of any subsequent material non-public information participants may receive Plan participants must satisfy Bombardier’s minimum stock ownership guidelines for senior executives MONTRÉAL, Aug. 15, 2018 (GLOBE NEWSWIRE) -- Bombardier announced today that it has established an automatic securities disposition plan (“ASDP”) in accordance with applicable Canadian provincial securities legislation. The ASDP allows for the exercise and sale of vested securities earned by certain senior executives of Bombardier as part of their overall performance-based compensation. Under Canadian securities
Williams Scotsman Completes ModSpace Acquisition15.8.2018 22:05 | Pressemelding
BALTIMORE, Aug. 15, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (Nasdaq: WSC) (“Williams Scotsman”), the leading specialty rental services provider of innovative modular space and portable storage solutions across North America, today announced that it has completed its acquisition of Modular Space Holdings, Inc. (“ModSpace”) for a total purchase price of approximately $1.2 billion. With the addition of ModSpace, Williams Scotsman now manages over 160,000 modular space and portable storage units serving an even broader customer base from over 120 locations across the United States, Canada and Mexico. The acquisition also expands the breadth and depth of its Ready to Work solutions to existing and incremental customers and markets. Brad Soultz, President and Chief Executive Officer of Williams Scotsman, commented, “We are pleased to confirm the completion of this transformational acquisition and would like to thank our collective customers, employees, and stakeholders for their suppor
Cisco Reports Fourth Quarter and Fiscal Year 2018 Earnings15.8.2018 22:05 | Pressemelding
• Q4 Results: Revenue: $12.8 billion ▪ Increase of 6% year over year ▪ Recurring revenue was 32% of total revenue, up 1 point year over year Earnings per Share: GAAP: $0.81; Non-GAAP: $0.70 ▪ Non-GAAP EPS increased 15% year over year • FY 2018 Results: Revenue: $49.3 billion; increase of 3% year over year Earnings per Share: GAAP: $0.02; Non-GAAP: $2.60 ▪ Non-GAAP EPS increased 9% year over year ▪ GAAP results include a $10.4 billion charge related to the enactment of the Tax Cuts and Jobs Acts • Q1 FY 2019 Guidance: Revenue: 5% to 7% growth year over year Earnings per Share: GAAP: $0.69 to $0.74; Non-GAAP: $0.70 to $0.72 SAN JOSE, Calif., Aug. 15, 2018 (GLOBE NEWSWIRE) -- Cisco today reported fourth quarter and fiscal year results for the period ended July 28, 2018. Cisco reported fourth quarter revenue of $12.8 billion, net income on a generally accepted accounting principles (GAAP) basis of $3.8 billion or $0.81 per share, and non-GAAP net income of $3.3 billion or $0.70 per share.
Algeco Announces Second Quarter 2018 Financial Results Conference Call and Change to Reporting in Euro15.8.2018 18:00 | Pressemelding
BALTIMORE, Aug. 15, 2018 (GLOBE NEWSWIRE) -- Algeco Investments B.V. (together with its subsidiaries, “Algeco”), the leading global business services provider of modular space, secure portable storage solutions and remote workforce accommodations, today announced that it will hold its second quarter 2018 financial results conference call on Wednesday, August 29, 2018 at 10:00 a.m., Eastern Time. To access the call, please dial (847) 585-4422 or (888) 424-8151 (US toll free) and enter participant PIN code 6638830# approximately ten minutes prior to the start of the call. You will be placed on hold until the event begins. The conference call will also be broadcast over the internet with an accompanying slide presentation. To join the web conference, go to http://web.meetme.net/r.aspx?p=2&a=UTiLPVrenccJZd. Please enter your name, email address and company to join the call. The customer service team can be reached at any time by pressing *0 on your telephone keypad. Prior to the call, the
Huobi Joins GLASS Network and Invests in SharesPost15.8.2018 15:00 | Pressemelding
Huobi joins network enabling compliant trading of digital securities globally San Francisco, CA, Aug. 15, 2018 (GLOBE NEWSWIRE) -- SharesPost, a leading provider of liquidity solutions to the private growth asset class, has announced that Huobi, China’s largest cryptocurrency and blockchain token exchange and second largest worldwide, has joined the Global Liquidity and Settlement System network (GLASS). When GLASS becomes operational, Huobi will be able to settle secondary trades of digital securities by U.S. investors in compliance with U.S. securities laws. Huobi will also be able to pool its nine million customers’ buy and sell orders with other exchanges using GLASS on a trading pair by trading pair basis. Greg Brogger, Founder and CEO of SharesPost, said: “We are very excited to see GLASS validated by such a highly respected trading platform. It signals the start of the next stage of development in the digital securities market, and we expect it will go a long way to clearing the
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom