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Home  /  Forum  /  Koffiekamer  /  Nanobiotix met haar NBTXR3 richting €80,- in 2014 ? (Heden €17,-)

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Nanobiotix met haar NBTXR3 richting €80,- in 2014 ? (Heden €17,-)

524 Posts
Pagina: «« 1 ... 5 6 7 8 9 ... 27 »» | Laatste | Omlaag ↓
  4. [verwijderd] 1 juni 2014 15:02
    Letterlijk vertaald.
    fr.news.yahoo.com/cancer-chercheurs-o...

    Oncologen hebben nooit aangegeven als optimistisch over de vooruitgang in de strijd tegen kanker in de afgelopen decennia, terwijl dat de enige medische wetenschap de ziekte die is grotendeels het gevolg van de levensstijl en andere niet kan overwinnen , milieu-en sociale.
    "Wetenschappelijk gezien is de kanker nooit zo spannend geweest," vertelde hij de president-elect van de American Society of Clinical Oncology (ASCO), Dr Clifford Hudis, vertelde verslaggevers op de eerste dag van de jaarlijkse conferentie die samen meer dan brengt 30.000 wetenschappers, artsen en vertegenwoordigers van farmaceutische bedrijven dit weekend in Chicago (Illinois, Noord).
    Hij haalde nieuwe therapieën gericht op specifieke functies waarmee kankercellen tegen agressieve vormen van kanker zoals melanomen waartegen oncologen niet echt de behandeling er een paar jaar te behandelen. Ook, immunotherapie, wat inhoudt herprogrammeren het immuunsysteem die de kwaadaardige cellen aanvallen, heeft veelbelovende resultaten opgeleverd.
    Deel dit optimisme, Dr Jyoti Patel, een specialist op longkanker in de Faculteit der Geneeskunde aan de Northwestern University in Chicago, zei in een interview met AFP "ongelooflijke vooruitgang in de afgelopen 50 jaar zijn in 2014 zullen er bijna 14 miljoen overlevenden van kanker in de Verenigde Staten, een aantal zal naar verwachting verdubbelen in de komende decennia. "
    Sterfte aan deze ziekte blijft tot 1,5% per jaar afnemen voor tien jaar en een persoon met de diagnose vandaag de dag meer dan 66% kans op leven na vijf jaar, volgens de federale statistieken.
    "Wat was het meest opwindende deze laatste twintig of dertig jaar heeft het begrip van de biologie van kanker, een gezamenlijke onderzoeksinspanning aan catalogus de vervaardiging van moleculaire afwijkingen die kankergezwellen karakteriseren", zegt de arts, tevens lid van coaching ASCO viert haar vijftigste jaarlijkse conferentie van dit jaar.
    "Vooruitgang in Cancer Research optreedt in een snel tempo, steeds nieuwe geneesmiddelen en therapieën ongekende snelheid," merkt Dr Richard Schilsky, de medische ambtenaar van ASCO.
    - Obesitas is een risicofactor -
    Maar zet het in de wacht, "deze vooruitgang wordt bedreigd" door de daling van de constante dollars sinds 2001 23% van de begroting voor onderzoek door het Congres de National Institutes of Health (NIH), wat neerkwam op 28 toegewezen 9 miljard in 2013 en is de belangrijkste bron van financiering voor fundamenteel biomedisch onderzoek.
    "De voortdurende investeringen in het land in het onderzoek is essentieel om meer vooruitgang tegen kanker te maken en versnellen van de voortgang" benadrukte de voorzitter van ASCO, Dr Hudis.
    "We moeten ook dieper in onze wetenschappelijke kennis om zowel risicofactoren aanpakken voor kanker in de omgeving en de levensstijl die de ziektelast van het land te verhogen," zei hij, daarbij verwijzend naar roken en overgewicht en obesitas.
    "Terwijl roken lang de grootste risicofactor voor kanker is geweest, obesitas is een groeiend probleem dat niet alleen de Verenigde Staten beschouwen, maar in de rest van de wereld. Volgens een studie die onlangs gepubliceerd in het medische tijdschrift Brits Lancet, een derde van de wereldbevolking lijdt? obesitas of overgewicht die merkte Dr Hudis, het risico op verschillende kankers, waaronder colon-en prostaatkanker aanzienlijk verlengt.
    Volgens hem "obesitas is klaar om het gebruik van tabak in de Verenigde Staten als de belangrijkste vermijdbare oorzaak van kanker in te halen."
    - De zon, een risicofactor -
    Dr Patel gelooft dat "twee derde van kanker kan worden voorkomen door het veranderen van onze levensstijl, onze voeding en het verminderen van onze blootstelling aan zonlicht."
    Zij benadrukt eveneens de noodzaak van voorlichtingscampagnes voor grootschalige vaccinatie tegen humaan papillomavirus verantwoordelijk voor de meeste vormen van kanker van de baarmoederhals en tegen hepatitis wat zich kan ontwikkelen tot leverkanker.
    "We moeten ook beter onderwijs en strengere regelgeving van tabak", zegt de oncoloog.
    Milieu, heeft recent onderzoek uitgewezen dat vrouwen dagelijks werden blootgesteld aan 17 kankerverwekkende stoffen kan een aanzienlijke verhoging van het risico van borstkanker, de tweede oorzaak van overlijden door kanker in de Verenigde Staten.
  7. [verwijderd] 2 juni 2014 07:26
    meetinglibrary.asco.org/content/12744...

    Background: Functionalized hafnium oxide nanoparticles (NBTXR3) have been developed as selective radioenhancers, which may represent a breakthrough approach for the local treatment of solid tumors. This is a unique approach where crystalline nanomaterials with high electron density when exposed to radiotherapy, can allow penetrate into the cell and make feasible the absorption/deposition of a high energy dose within the tumor cell. A phase I/II trial was implemented in patients with locally advanced STS. Methods: Patients (pts)received a single intratumor (IT) injection of NBTXR3, volume escalated, followed by 50Gy RTx (see Table). Primary endpoints include feasibility of the IT implantation and safety. Secondary endpoints focus on efficacy such as pathological and RECIST response, IT residency of NBTXR3 over all the RTx period and operability. Results: Enrollment was completed for volume 1, 2, and 3 (15 pts). Feasibility of the IT injection was confirmed. The treatment was safe with no SAE, no early DLT and allowed the pts for completion of the planned RTx schedule. No grade 3-4 toxicity occurred, main grade 1-2 toxicities related to NBTXR3 were injection pain/reaction (4 pts), pyrexia (2 pts), abdominal pain (1 pt), pruritus (1 pt) and paresthesia (1 pt). Results demonstrated that a single injection of NBTXR3 provides adequate bioavailability of NBTXR3 IT over five weeks of radiotherapy. No leakage of NBTXR3 to the adjoining healthy tissues was observed. Further, NBTXR3 persistence was established by CT scan before surgery. Conclusions: Injection of NBTXR3 was well tolerated. All pts received the planned radiotherapy (50 Gy/25 fractions/ 5 weeks) followed by wide surgical resection of the sarcoma. NBTXR3 with RTx showed a very good safety profile. Encouraging signs of antitumor activity were observed in different sarcoma subtypes, such as undifferentiated sarcoma, rhabdomyosarcoma, and synovial sarcoma, which constitutes a promising feature for this subset of pts whose primary tumor is locally advanced and has an important risk of relapse. Clinical trial information: NCT01433068.

  8. [verwijderd] 2 juni 2014 08:08
    Nanobiotix presents successful Phase I results for its lead nanomedicine product NBTXR3 at ASCO

    Small but heading for the big time

    Nanobiotix presents successful Phase I results for its lead nanomedicine product NBTXR3 at ASCO

    Final results demonstrate a very good safety, treatment feasibility and promising signs of efficacy in patients with advanced Soft Tissue Sarcomas

    NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announced the successfulcompletion of the first in human study of its lead NanoXray product, NBTXR3, which will be presented today at the American Society of Clinical Oncology (ASCO) annual meeting.

    The Phase I clinical study established that intratumoral injection of NBTXR3 followed by radiotherapy has a good safety profile in patients with locally advanced soft tissue sarcoma (STS), who have an important risk of relapse and few treatment options.

    These results allow Nanobiotix to proceed to the pivotal phase, which is the final step leading to registration (CE mark).

    The study showed that promising signs of antitumor activity for different sarcoma subtypes were observed. Interestingly, tumor shrinkage and pathological response were observed in well-known refractory tumors. All patients underwent a wide surgical resection. This optimal surgery impacts the local recurrence rate, improving patient prognosis since local disease control prolongs progression free survival and overall survival in high grade sarcomas.

    Elsa Borghi, CMO of Nanobiotix said: "These results are really encouraging, the feasibility of injecting different sarcoma subtypes with varying volumes of NBTXR3 nanoparticles was tested in this phase I study and a very good tolerance was observed. We are pleased to announce that each patient has been successfully operated on. This has reinforced the fact that radiotherapy with NBTXR3 has the potential to be an effective pre-operative treatment and offer meaningful clinical benefit to patients with advanced Soft Tissue Sarcoma (STS). Now, further development of NBTXR3 is warranted and a pivotal trial is planned to start in Q4 2014."

    The study enrolled 20 patients who received a single intratumoral injection of NBTXR3, at escalating volumes, followed by standard radiotherapy (50Gy RTx), as indicated in this clinical setting.

    Primary endpoints included feasibility of the intratumoral implantation and safety. Secondary endpoints focused on the efficacy such as pathological response and RECIST (Response Evaluation Criteria In Solid Tumors) response, including tumor volume evaluation. Moreover, IntraTumoral permanence of NBTXR3 and operability were assessed.

    Key findings:

    Feasibility of the NBTXR3 injection within the tumor mass across different tumor types and volumes (from 55.06ml to 3682.56ml) was demonstrated.
    No leakage of NBTXR3 to the surrounding healthy tissues was confirmed.
    Persistence of NBTXR3 during all sessions of radiotherapy: optimal bioavailability over time.
    Appropriate dispersion of the product within the tumor: diffusion in 3 dimensions.
    Very good tolerance and local safety of the product at volume 2.5%, 5%, 10% and 20% was observed.
    Promising signs of antitumor activity were observed in different sarcoma subtypes, such as undifferentiated sarcoma, rhabdomyosarcoma, and synovial sarcoma.
    The recommended volume for the pivotal study is 10%.
  9. [verwijderd] 2 juni 2014 08:09
    Laurent Levy, CEO of Nanobiotix commented: "The completion of this Phase I study is a very important milestone for Nanobiotix. The next step for us is to initiate a pivotal study for NBTXR3 in patients with advanced soft tissue sarcomas. We expect to start enrolling patients by the end of 2014. This successful feasibility of our NBTXR3 approach in cancer patients also encourages us to expand the use of NBTXR3 in other indications like head and neck cancer, liver cancer, glioblastoma, rectal cancer and prostate cancer, and to think about developments of our other products, NBTX-IV and NBTX-TOPO."

    Detailed results

    Feasibility of the intratumoral injection was confirmed.

    The injection procedure was performed under local anesthesia and pre-medication with analgesic and sedative products. This first step of the clinical development demonstrated the feasibility of NBTXR3 intratumor injection at the 3 first volume levels, followed by radiotherapy.

    The treatment was safe
    No early dose-limiting toxicity (DLT) was observed. Patients received the complete planed radiotherapy scheduled and dose. No grade 3-4 toxicity related to NBTXR3 occurred. Main grade 1-2 adverse events included injection pain/reaction, pyrexia, abdominal pain, pruritus and paresthesia.

    Adequate bioavailability was demonstrated
    Results confirmed that a single injection provides adequate bioavailability of NBTXR3 within the tumor over the five weeks of radiotherapy. No leakage of NBTXR3 to the healthy tissues was observed. Further, the evaluation demonstrated the permanence of NBTXR3 within the tumor, before surgery, i.e. 6 weeks after the end of the radiotherapy.

    Promising signs of antitumor activity were observed in different sarcoma subtypes.
    The basis of the management of the Soft Tissue Sarcoma patients is surgery. The wider the local excision, the lower the probability of cancer recurrence and amputation need. Currently and despite of pre-operative radiotherapy, surgery is still very challenging in the subset of patients with locally advanced soft tissue sarcoma of the extremity and trunk wall.

    In this population, NBTXR3 activated by radiotherapy showed promising signs of antitumor activity in different sarcoma subtypes.

    3/17 patients had pathological Response superior or equal to 90%.
    At 10% volume of NBTXR3, the average pathological Response was 74%
    Average tumor shrinkage increasing with NBTXR3 volume
    Volume 2.5% , average of tumor volume shrunk was 18%
    Volume 5%, average of tumor volume shrunk was 38%
    Volume 10%, average of tumor volume shrunk was 49%
    All patients treated in the study had a wide surgical resection of the tumor
    Notes to editors

    About NBTXR3 in Soft Tissue Sarcoma (STS)

    STS are cancers arising from different types of tissues such as fat cells, muscles, joint structures and small vessels etc. In resectable cases, surgery is the only potentially curative treatment and constitutes the basis to achieve prolonged survival.
    Nevertheless, a considerable proportion of patients present with locally advanced primary or relapsed tumors and cannot be resected with clean margins. These patients with big tumors are threatened with amputation for complete tumor removal. Progress of surgical techniques and the use of pre-operative radiotherapy have improved the disease outcome. However local and distant failures are frequently observed.

    There is strong evidence (scientific literature) that supports the importance of local control of tumor in patients with locally advanced STS. Indeed, achieving local control in these patients presenting with locally advanced disease is a determinant factor to improve disease free survival and overall survival. This is not surprising. Similar outcome is observed for other cancers.

    Patients with high risk STS have few therapeutic options. Innovative treatments aimed at optimizing cancer cell killing and the surgical feasibility are needed.

    Treatment with NBTXR3 nanoparticles and radiotherapy in locally advanced STS aims to destroy tumors more efficiently, to facilitate surgery and enable complete malignant tissue extraction during surgery.

    NBTXR3 is a selective radioenhancer. The injected nanoparticles penetrate tumor cells and when exposed to radiotherapy make feasible the deposition of a high energy dose within the cancer cell, increasing cell killing and thus improving resectability and disease outcome.

    For more information:
    clinicaltrials.gov/ct2/show/NCT014330...

    About NANOBIOTIX - www.nanobiotix.com

    Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a clinical-stage nanomedicine company pioneeringnovel approaches for the local treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat a wide variety of cancers (Soft Tissue Sarcoma, Breast Cancer, Liver Cancer, H&N cancer, Glioblastoma, Prostate.) via multiple routes of administration.

    Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma and locally advanced head and neck cancer. The Company, based in Paris, France, has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia.

    Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP).
524 Posts
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