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BioPharma Terug naar discussie overzicht

THLD - Treshold -Pancreatic cancer

75 Posts
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  2. [verwijderd] 30 augustus 2011 17:05

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    THLD volume very much dried up, still due 2b final data presentation end of year on pancreatic cancer, will run hard in coming weeks/months. Full position accumulated last three weeks for longer swing bit.ly/oRPUtX
  5. [verwijderd] 3 februari 2012 13:50

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    4k 1.33-1/35 entry

    THLD BINGO today ! Merck deal!!!!

    BRIEF-Threshold Pharmaceuticals and Merck enter agreement on phase 3 hypoxia-targeted drug

    Feb 3 (Reuters) - Threshold Pharmaceuticals Inc <THLD.O>:
    * Threshold Pharmaceuticals and Merck KGaA announce global agreement to
    co-develop and commercialize phase 3 hypoxia-targeted drug TH-302
    * Says Threshold to receive $25 million upfront, plus further potential
    milestones and royalties
    * Says deal provides Threshold option to co-commercialize in the United States
    * Says could receive up to $35 million in additional development milestones
    during 2012
    * Says phase 3 trial in soft tissue sarcoma on-going
    * Says total potential milestone payments are $525 million
    * Says in the United States, Threshold will have primary responsibility for
    development of TH-302
    * Says Threshold and Merck KGaA will jointly develop TH-302 in all other cancer
    indications being pursued
    * Says Merck KGaA will pay 70% of worldwide development costs for TH-302
    * Under terms of agreement, Merck will receive co-development rights, exclusive
    global commercialization rights
    * Says Merck will also provide Threshold an option to co-commercialize the
    therapeutic in the United States
    * Threshold Pharmaceuticals Inc <THLD.O> says Merck KGaA will pay 70% of
    worldwide development costs for th-302

    ((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))

    ((For more news, please click here [THLD.O]))

  9. [verwijderd] 4 februari 2012 07:59

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    wat een rit gisteren, heb 2/3 verkocht, entry $1,22. De overige bewaar ik voor de lange termijn, deal ziet er echt heel erg goed uit en laat zien dat THLD heel veel potentieel heeft. Wat je zegt klopt helemaal Crack, winst in locken is heel belangrijk, deed ik vroeger veel minder en dan was er uiteindelijk weer verlies, te hebberig worden is niet goed! Grtz
  13. [verwijderd] 16 februari 2012 16:51

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    Nee Bassie phase 2. Deal met Merck KGaA was/is voor Phase 3 drug soft tissue sarcoma. Ze verwachten binnenkort phase 2 data voor pancreatic cancer. BTW bpax valt vies tegen ik ben gewoon blijven zitten ..niet zo slim achteraf
  14. [verwijderd] 16 februari 2012 17:03

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    he junk oke bedankt voor de info had me idd vergist het gaat om een p2 en wb bpax valt me inderdaad erg tegen had beter verw8 21 miljoen shorts die de koers naar beneden drukken dus weer rustig w88 helaas
  17. [verwijderd] 21 februari 2012 11:51

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    Threshold Pharmaceuticals Announces Positive Phase 2b Clinical Trial Results of TH-302 in Patients With Pancreatic <THLD.O>

    SOUTH SAN FRANCISCO, CA, Feb 21 (MARKET WIRE) --
    Threshold Pharmaceuticals, Inc. (NASDAQ: THLD)


    -- Primary endpoint of Progression Free Survival was met with hazard
    ratio of 0.61 (p = 0.005).
    -- The combination therapy was well tolerated with a safety profile
    consistent with prior studies.



    Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that
    its 214 patient randomized controlled Phase 2b clinical trial evaluating
    the efficacy and safety of two doses of the investigational agent TH-302
    in combination with gemcitabine compared to gemcitabine alone in patients
    with first-line advanced pancreatic cancer achieved its primary endpoint,
    with a 63% improvement in progression free survival and a safety profile
    consistent with previous studies. "With the results of this trial, we are
    again very encouraged that TH-302 is conferring benefit to patients with
    aggressive and difficult to treat cancers," said Barry Selick, Ph.D.,
    Chief Executive Officer of Threshold. "We look forward to its ongoing
    development with our partner Merck KGaA in this and other indications."

    Clinical Trial Design
    Study TH-CR-404 is a multi-center, randomized,
    controlled, dose-ranging, Phase 2b crossover clinical trial of TH-302 in
    combination with gemcitabine in patients with first line advanced
    pancreatic cancer. The primary endpoint of the trial is progression-free
    survival. The secondary endpoints are overall response rate, overall
    survival, change in CA19-9 as well as various other efficacy and safety
    parameters. Tumor response was evaluated at baseline and every eight
    weeks using RECIST. Patients for whom monotherapy with gemcitabine is
    considered standard therapy were eligible for the trial. Patients were
    randomized equally into one of three cohorts: TH-302 at a dose of 240
    mg/m2 plus gemcitabine, TH-302 at a dose of 340 mg/m2 plus gemcitabine,
    or gemcitabine alone. Patients who successfully completed six cycles of
    treatment without evidence of significant treatment-related toxicity or
    progressive disease could continue to receive treatment. If a patient
    experienced cancer progression on gemcitabine alone, the patient could
    cross over into one of the TH-302 plus gemcitabine cohorts. The primary
    efficacy analysis was performed based upon 149 investigator-assessed PFS
    events and, per protocol, pooled data from the two gemcitabine plus
    TH-302 dose groups in comparison to gemcitabine alone.

    Results
    The
    median progression-free survival (PFS) was 5.6 months for patients
    treated with gemcitabine in combination with TH-302 at 240 mg/m2 and 340
    mg/m2 compared to 3.6 months for patients treated with gemcitabine alone.
    The PFS hazard ratio comparing the TH-302 combination to gemcitabine
    alone was 0.61 (95% confidence interval: 0.43 - 0.87) which was highly
    statistically significant (p = 0.005). The response rate in the
    combination arms was 22% compared to 12% in the gemcitabine alone group.
    Results also demonstrated greater efficacy in the higher TH-302 dose
    group compared to the lower dose group.

    The combination was well tolerated with a safety profile that was
    consistent with our prior study of this combination regimen. As in that
    study, skin and mucosal toxicities related to TH-302 were dose dependent
    but not dose limiting. Further detailed information regarding the results
    of this trial will be presented at a future major medical conference.

    "This study provides the proof of concept demonstration that TH-302
    contributes to the efficacy of a known active agent and supports the
    rationale for combining TH-302, a hypoxia targeting agent, with other
    approved therapies," said Stew Kroll, Senior Vice President of
    Biostatistics and Clinical Operations of Threshold.

    About Pancreatic Cancer
    Pancreatic cancer is a malignant neoplasm of
    the pancreas with current treatment options including surgery,
    radiotherapy and chemotherapy. Gemcitabine as a single agent or in
    combination with other treatments is the most commonly used
    chemotherapeutic agent in patients with advanced pancreatic cancer. It is
    estimated that approximately 279,000 cases of pancreatic cancer were
    diagnosed worldwide in 2008. Pancreatic cancer is the fourth most common
    cause of cancer death both in the United States and internationally. The
    American Cancer Society estimates that 44,030 people were diagnosed with
    pancreatic cancer in the United States in 2011, and approximately 37,660
    people died from the disease.

    About TH-302
    TH-302 is a hypoxia-targeted drug that is thought to be
    activated under tumor hypoxic conditions, a hallmark of many cancer
    indications. Areas of low oxygen levels (hypoxia) within tissues are
    common in many solid tumors due to insufficient blood vessel growth.
    Similarly, the bone marrow of patients with hematological malignancies
    has also been shown, in some cases, to be extremely hypoxic. TH-302 has
    been investigated in over 550 patients in Phase 1/2 clinical trials to
    date in a broad spectrum of tumor types, both as a monotherapy and in
    combination with chemotherapy treatments and other targeted cancer drugs.
    Threshold has several ongoing clinical trials with TH-302 including, but
    not limited to, a Phase 3 trial of TH-302 in patients with first-line
    advanced soft tissue sarcoma (STS). This randomized, multi-center Phase 3
    trial will investigate the use of TH-302 plus doxorubicin compared with
    doxorubicin alone. The primary efficacy endpoint is overall survival. The
    study is conducted under a Special Protocol Assessment with the U.S. Food
    and Drug Administration. It is being run in partnership with the Sarcoma
    Alliance for Research through Collaboration (SARC) and aims to enroll 450
    patients with metastatic or locally advanced unresectable STS.

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