Recent

% | $
Quotes you view appear here for quick access.

Optimer Pharmaceuticals, AŞ Message Board

francolaval 15 posts  |  Last Activity: Jul 20, 2015 11:42 AM Member since: Mar 22, 2002
  • francolaval francolaval Jul 20, 2015 11:42 AM Flag

    Well, as I said in the past, she's THE SUPER KEY, early adopter, knowledegable investigator.She's had a few presentation on immunotherapy this year. She has one upcoming in July. This one in September is quite interesting...update on the phase III........hmmmm....quite interesting....

  • http://boulderpeptide.org/boulder-peptide-agenda

    This presentation will focus of the clinical trials evaluating NeuVax, a peptide vaccine comprised of the immunogenic epitope E75 and the immunoadjuvant GM-CSF. An update on the ongoing phase III registration trial will be presented.

  • September 29th presentation:

    Injecting Hope: Clinical Development of the NeuVax Vaccine

    Elizabeth Mittendorf

    Associate Professor, Deputy Chair Research, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center

    ABSTRACT

    This presentation will focus of the clinical trials evaluating NeuVax, a peptide vaccine comprised of the immunogenic epitope E75 and the immunoadjuvant GM-CSF. An update on the ongoing phase III registration trial will be presented.

    BIO

  • francolaval francolaval Jun 27, 2015 6:15 PM Flag

    She would not present on this particular topic if she saw her own patients on phase 2 and phase 3 trial relapse. She has best clinical knowledge about the efficacy of neuvax. Stay tuned.

  • http://www.mdanderson.org/education-and-research/education-and-training/schools-and-programs/cme-conference-management/conferences/final-pn-brochure-may-28---agenda.pdf

  • www.curetoday.com/.../is-immunotherapy-ready-for-...
    Elizabeth A. Mittendorf, associate professor of surgical oncology at The University of Texas MD ... PUBLISHED THURSDAY, MARCH 26, 2015 ... breast cancer trials during her presentation at the 32nd Annual Miami Breast Cancer Conference.

    She has given a few talks in 2015, a few more between now and December 2015. She's the super-key investigator, super-keychampion any biotech or pharma would love to have on board. She does not give talks because she has free time.............she believes in what she does and see.

  • Mittendorf is on a presentation rampage. ALL GOOD. She's a super key investigator.

  • FIGO (Oct 2015) or ACOS (Sept 2015).

  • Boulder Peptide Symposium -

    Injecting Hope: Clinical Development of the NeuVax Vaccine

    This presentation will focus of the clinical trials evaluating NeuVax, a peptide vaccine comprised of the immunogenic epitope E75 and the immunoadjuvant GM-CSF. An update…

    Elizabeth Mittendorf Associate Professor, Deputy Chair Research, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center

  • Presentation by Dr Nanda at the June Int. Conf. of Future of Breast CA.
    She's an important co-investigator in Neuvax trial.

  • francolaval by francolaval May 22, 2015 3:39 PM Flag

    Offer is on the table????

  • francolaval by francolaval May 22, 2015 8:44 AM Flag

    Abstract: P671

    Type: Poster Presentation

    Presentation during EHA20: From 13.06.2015 17:15 to 13.06.2015 18:45

    Location: Poster area (Hall C)

    Background
    Despite advances in the diagnosis and management of MPNs, treatment of essential thrombocythemia (ET) has remained largely unchanged since the introduction of anagrelide in the US (1997) and Europe (2004). Anagrelide reduces platelet production by inhibition of megakaryocyte hypermaturation, and also inhibits cyclic AMP phosphodiesterase III. Common drug related adverse events (AEs; e.g., headache, palpitations, fluid retention, etc.) might be due to this latter mechanism. As the marketed anagrelide product is an immediate release (IR) formulation with peak plasma levels that may exceed that needed for platelet reduction, an alternate formulation that modifies this pharmacokinetic (PK) profile may improve patient tolerability and treatment outcomes. This led to the development of a controlled-release (CR) formulation of anagrelide (GALE-401). To-date, 98 healthy subjects were enrolled among 5 Phase 1 clinical trials of anagrelide CR at doses ranging from 0.2 to 0.6 mg once or twice daily for up to 42 days. Anagrelide CR induced significant reductions in platelet counts that were not distinguishable from IR, despite Cmax and AUC0-τ values that were 29% and 55% of IR. These trials supported the initiation of a Phase 2 study in MPN-related thrombocytosis, preliminary results for which are reported here.

    Aims
    The primary objective of the study was to estimate the overall platelet response rate (ORR). Secondary objectives included safety, tolerability, and pharmacokinetics (PK).

    Methods

    This is an open-label, single-arm, Phase 2 trial. Eligible subjects include those with chronic myelogenous leukemia (CML), polycythemia vera (PV), primary myelofibrosis (PMF) or ET, platelet count ≥ 600 K/μL, and not previously refractory to anagrelide. Anagrelide CR was given at a starting dose of 0.5 mg twice daily and individually titrated to maintain a target platelet count of 150 - 400 K/μL. Platelet response is defined as complete response (CR, ≤ 400 K/μL) or partial response (PR, ≤ 600 K/μL or ≥ 50% reduction from baseline), and maintenance of the reduction for at least 4 weeks. Safety evaluations include routine physical and laboratory evaluations. The PK profile is assessed at the starting dose, weekly sampling during dose titration, and at the final titrated dose level.

    Results
    Eighteen (18) subjects who provided written informed consent were enrolled, median age 65 yrs (range 40-80), 10 females/8 males, 13 ET, 4 PV, and 1 PV/ET. Prior treatments for thrombocytosis included hydroxyurea (n=8), anagrelide (8), and none (7). Mean platelet count decreased rapidly to

  • Reply to

    I'm starting to think the shorts....

    by paul.lyons619 May 8, 2015 10:23 AM
    francolaval francolaval May 8, 2015 11:34 AM Flag

    Yes - totally non-AMERICAN. They are paid bashers. They are paid bashers and post every minute. They should be banned.

  • francolaval by francolaval May 8, 2015 9:35 AM Flag

    She's multiplying her talks. WHY? Why would she so openly discuss immunotherapy in breast, and talk about the potential of neuvax? Why? To be shot down by the medical community when phase III results turn out negative? Really? Why has she driven additional trials with neuvax? To content Gale? Really?
    As a pharma veteran, I can tell you that super-key investigators that undertake such initiatives are the best thing ever for pharma....just the best And she gets to see on a daily basis the evolving results of her phase II patients and her phase III patients.. THAT'S why she can openly talk about immunotherapy with neuvax in breast. That's why she is CONFIDENT.

  • francolaval by francolaval May 1, 2015 3:59 PM Flag

    Science will prevail. Always does. Immunotherapy is new for clinicians and FDA. Targeted therapy is also new. It just normal that NeuVax be tested in sub-population. It's definately not cherry picking. Good luck...and oh, GALE-301 moving to pivotal phase III. See you at 100$.