Fennec (Mkap 19 M€) 2x Phase 3 Positiv = 2016 H1 - mit Zulassung? (Seite 11)
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ISIN: CA31447P1009 · WKN: A12A5F · Symbol: FENC
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waren die news doch nicht so gut oder nur sell on good news ?
Habe leider nur ein Teil für 12,50 € verscherbelt.
Habe leider nur ein Teil für 12,50 € verscherbelt.
14,92€ in FFM und 13$ in USA hehe okay
Geilo 
http://www.stockwatch.com/News/Item.aspx?bid=Z-C:FRX-2516057
Mr. Rosty Raykov reports
FENNEC ANNOUNCES POSITIVE RESULTS FROM PHASE 3 SIOPEL 6 STUDY ON PEDMARK (SODIUM THIOSULFATE) PRESENTED AT THE 49TH CONGRESS OF THE INTERNATIONAL SOCIETY OF PEDIATRIC ONCOLOGY (SIOP) 2017 MEETING
Fennec Pharmaceuticals Inc. has released data from its phase 3 SIOPEL 6 study, which were presented during the late breaker session on Saturday, Oct. 14, 2017, at SIOP 2017 in Washington.
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 PEDMARK 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:
Adverse event GradeCIS CIS+STS
N % N %
Febrile neutropenia3 7 13.55 8.8
4 - - - -
Infection 3 5 9.6 6 10.5
4 - - - -
Hypomagnesemia 3 1 1.9 1 1.8
4 - - - -
Hypernatremia 3 - - 1 1.8
4 - - - -
Vomiting 3 1 1.9 3 5.3
4 - - - -
Nausea 3 3 5.8 2 3.5
4 - - - -
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
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 =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 = 1 hearing loss determined after the end of treatment at the age of =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 clinical@fennecpharma.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.
http://www.stockwatch.com/News/Item.aspx?bid=Z-C:FRX-2516057
Mr. Rosty Raykov reports
FENNEC ANNOUNCES POSITIVE RESULTS FROM PHASE 3 SIOPEL 6 STUDY ON PEDMARK (SODIUM THIOSULFATE) PRESENTED AT THE 49TH CONGRESS OF THE INTERNATIONAL SOCIETY OF PEDIATRIC ONCOLOGY (SIOP) 2017 MEETING
Fennec Pharmaceuticals Inc. has released data from its phase 3 SIOPEL 6 study, which were presented during the late breaker session on Saturday, Oct. 14, 2017, at SIOP 2017 in Washington.
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 PEDMARK 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:
Adverse event GradeCIS CIS+STS
N % N %
Febrile neutropenia3 7 13.55 8.8
4 - - - -
Infection 3 5 9.6 6 10.5
4 - - - -
Hypomagnesemia 3 1 1.9 1 1.8
4 - - - -
Hypernatremia 3 - - 1 1.8
4 - - - -
Vomiting 3 1 1.9 3 5.3
4 - - - -
Nausea 3 3 5.8 2 3.5
4 - - - -
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
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 =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 = 1 hearing loss determined after the end of treatment at the age of =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 clinical@fennecpharma.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.
News Out ! positive P3 Daten
Antwort auf Beitrag Nr.: 55.958.829 von Schuro am 16.10.17 08:55:09Mag sein, SIOP 2017 Konferenz war am Wochenende......
Trading Spotlight
Antwort auf Beitrag Nr.: 55.958.709 von karpfenhai1 am 16.10.17 08:37:29Auf youtube haben die Videos ein VÖ-Datum per 04.05.2017 - scheinen also schon etwas älter zu sein.
https://www.youtube.com/watch?v=nT5aVL1dAYY" target="_blank" rel="nofollow ugc noopener">https://www.youtube.com/watch?v=nT5aVL1dAYY
https://www.youtube.com/watch?v=nT5aVL1dAYY" target="_blank" rel="nofollow ugc noopener">https://www.youtube.com/watch?v=nT5aVL1dAYY
Antwort auf Beitrag Nr.: 55.948.970 von karpfenhai1 am 13.10.17 17:17:23Video von oder zu der SIOP 2017 Konferenz
http://fennecpharma.com/a-new-era-in-hearing-loss-protection…
Gruss Karpfenhai
http://fennecpharma.com/a-new-era-in-hearing-loss-protection…
Gruss Karpfenhai
Kommt denn da heute Bewegung rein? Morgen gibts das Ergebnis nach Jahren des Durchhaltens......😨
Hopp oder Top würde ich sagen.Die Chancen stehen 50/50.... Viel Glück allen investierten.......🍀
Hopp oder Top würde ich sagen.Die Chancen stehen 50/50.... Viel Glück allen investierten.......🍀
Antwort auf Beitrag Nr.: 55.771.080 von tupper am 18.09.17 20:19:35$50 millionen Umsatz werden allein für USA angegeben bei $25000 pro behandlung das ist der stand von 2014 , ich denke da ist noch genug spielraum die behandlungskosten nach oben zuschrauben wenn man sieht was so ein Cochlear-implantat kostet nämlich 40000-50000 € pro stück und das schützt nicht vor Hörverlust .Und was die Zulassungsbehörden angeht mit der Unberechenbarkeit muss man leider leben .
STS Market Opportunity Pediatric Market Opportunity
• 12,000 children develop cancer in the US every year
• 2,000 children will receive platinum-based chemotherapy, 3x ROW
• At $25,000 per treatment: initial $50 mln US market pediatric opportunity
• Minimal sales infrastructure required, treating physicians are part of COG network
STS Market Opportunity Pediatric Market Opportunity
• 12,000 children develop cancer in the US every year
• 2,000 children will receive platinum-based chemotherapy, 3x ROW
• At $25,000 per treatment: initial $50 mln US market pediatric opportunity
• Minimal sales infrastructure required, treating physicians are part of COG network
Toll, wie man mit dieser Methode Geld verdienen kann!
Gibt es denn für die 100 Mio, die als möglicher Umsatz durch den Raum geistern, nachvollziehbare Zahlen? Wobei 50 Mio ja auch schon sehr gut wären!
Und ob die Zahlen der P3 und die Untersuchungsmethoden für eine Zulassung reichen, ist eben auch noch ungewiss (siehe Santhera).
Gibt es denn für die 100 Mio, die als möglicher Umsatz durch den Raum geistern, nachvollziehbare Zahlen? Wobei 50 Mio ja auch schon sehr gut wären!
Und ob die Zahlen der P3 und die Untersuchungsmethoden für eine Zulassung reichen, ist eben auch noch ungewiss (siehe Santhera).
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