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Novartis AG Message Board

strongbuy33 141 posts  |  Last Activity: Feb 3, 2016 8:56 PM Member since: Feb 8, 2012
  • Someone pull low the price keep loading up all shares? Anyone can tell why?

    Sentiment: Strong Buy

  • PFE offer buy out THLD.......

    Sentiment: Strong Buy

  • Sell MNKD all in THLD, end of Jan will get back all your loss

    That 2 drug failed endpoint maybe still have good chance for FDA approval......... and 2 P2 in thi June FDA approval.
    .

    View of NCT02093962 on 2016_01_04

    ClinicalTrials Identifier:
    NCT02093962

    Updated:
    2016_01_04

    Descriptive Information

    Brief title

    Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

    Official title

    A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer

    Brief summary

    The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.

    Detailed description

    TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.

    Phase
    Phase 2

    Study type
    Interventional

    Study design
    Treatment

    Study design
    Randomized

    Study design
    Double Blind (Subject, Caregiver, Investigator)

    Study design
    Parallel Assignment

    Study design
    Safety/Efficacy Study

    Primary outcome
    Measure: Overall survival
    Time Frame: 2 years
    Safety Issue? No
    Description:
    To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients

    Sentiment: Strong Buy

  • strongbuy33 by strongbuy33 Jan 12, 2016 7:32 AM Flag

    That 2 drug failed endpoint maybe still have good chance for FDA approval......... and 2 P2 in thi June FDA approval.
    .

    View of NCT02093962 on 2016_01_04

    ClinicalTrials Identifier:
    NCT02093962

    Updated:
    2016_01_04

    Descriptive Information

    Brief title

    Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

    Official title

    A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer

    Brief summary

    The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.

    Detailed description

    TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.

    Phase
    Phase 2

    Study type
    Interventional

    Study design
    Treatment

    Study design
    Randomized

    Study design
    Double Blind (Subject, Caregiver, Investigator)

    Study design
    Parallel Assignment

    Study design
    Safety/Efficacy Study

    Primary outcome
    Measure: Overall survival
    Time Frame: 2 years
    Safety Issue? No
    Description:
    To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo

    Secondary outcome
    Measure: Incidence and severity of adverse events in patients treated with TH-302 in combination with pemetrexed vs pemetrexed alone
    Time Frame: 2 years
    Safety Issue? Yes
    Description:
    To assess the safety of TH-302 in combination with pemetrexed compared with placebo and pemetrexed in this setting.

    Secondary outcome
    Measure: Population PK of TH-302 in patients treated with TH-302 for measures including clearance and volume of distribution
    Time Frame: 2 years
    Safety Issue? Yes
    Description:
    To investigate the pharmacokinetics of TH-302 in this patient population

    Secondary outcome
    Measure: Evaluate anti-tumor activity as measured by progression-free survival and response rate in patients treated with TH-302 in combination with pemetrexed vs pemetrexed alone
    Time Frame: 2 years
    Safety Issue? No
    Description:
    To evaluate the anti-tumor activity of pemetrexed in combination with TH-302 compared with pemetrexed in combination with placebo

    Enrollment
    440 (Anticipated)

    Condition
    Non-small Cell Lung Cancer

    Arm/Group

    Arm Label: TH-302 and pemetrexed Experimental

    TH-302 in combination with pemetrexed

    Arm/Group

    Arm Label: Placebo and pemetrexed Active Comparator

    Matching placebo in combination with pemetrexed

    Intervention

    Drug: TH-302 combination with pemetrexed Arm Label: TH-302 and pemetrexed

    400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

    Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.

    Intervention

    Drug: Matched placebo in combination with pemetrexed Arm Label: Placebo and pemetrexed

    Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

    Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.

    Recruitment Information

    Status
    Recruiting

    Start date
    2014-03

    Last follow-up date
    2018-04 (Anticipated)

    Primary completion date
    2017-10 (Anticipated)

    Criteria

    Inclusion Criteria:

    • Men and women ≥ 18 years of age.
    • Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology
    • Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
    • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated CTCAE Grade 1 dyspnea) that is not amenable to drainage
    • Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
    • Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
    • Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
    • Elective or a planned major surgery while on study treatment
    • Radiation therapy to greater than 25% of the bone marrow
    • Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
    • Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
    • Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
    • Pregnant or breast feeding
    • Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
    • Patients who are taking medications that are strong inducers or inhibitors of CYP3A4

    Gender
    Both

    Minimum age
    18 Years

    Healthy volunteers
    No

    Administrative Data

    Organization name
    Threshold Pharmaceuticals

    Organization study ID
    TH-CR-415

    Sponsor
    Threshold Pharmaceuticals

    Collaborator
    EMD Serono

    Health Authority
    United States: Food and Drug Administration

    Health Authority
    United States: Institutional Review Board Less

    Sentiment: Strong Buy

    Sentiment: Strong Buy

  • View of NCT02093962 on 2016_01_04

    ClinicalTrials Identifier:
    NCT02093962

    Updated:
    2016_01_04

    Descriptive Information


    Brief title

    Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer


    Official title

    A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer


    Brief summary

    The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.


    Detailed description

    TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.


    Phase
    Phase 2

    Study type
    Interventional

    Study design
    Treatment

    Study design
    Randomized

    Study design
    Double Blind (Subject, Caregiver, Investigator)

    Study design
    Parallel Assignment

    Study design
    Safety/Efficacy Study

    Primary outcome
    Measure: Overall survival
    Time Frame: 2 years
    Safety Issue? No
    Description:
    To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo


    Secondary outcome
    Measure: Incidence and severity of adverse events in patients treated with TH-302 in combination with pemetrexed vs pemetrexed alone
    Time Frame: 2 years
    Safety Issue? Yes
    Description:
    To assess the safety of TH-302 in combination with pemetrexed compared with placebo and pemetrexed in this setting.


    Secondary outcome
    Measure: Population PK of TH-302 in patients treated with TH-302 for measures including clearance and volume of distribution
    Time Frame: 2 years
    Safety Issue? Yes
    Description:
    To investigate the pharmacokinetics of TH-302 in this patient population


    Secondary outcome
    Measure: Evaluate anti-tumor activity as measured by progression-free survival and response rate in patients treated with TH-302 in combination with pemetrexed vs pemetrexed alone
    Time Frame: 2 years
    Safety Issue? No
    Description:
    To evaluate the anti-tumor activity of pemetrexed in combination with TH-302 compared with pemetrexed in combination with placebo


    Enrollment
    440 (Anticipated)

    Condition
    Non-small Cell Lung Cancer

    Arm/Group

    Arm Label: TH-302 and pemetrexed Experimental

    TH-302 in combination with pemetrexed


    Arm/Group

    Arm Label: Placebo and pemetrexed Active Comparator

    Matching placebo in combination with pemetrexed


    Intervention

    Drug: TH-302 combination with pemetrexed Arm Label: TH-302 and pemetrexed

    400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

    Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.


    Intervention

    Drug: Matched placebo in combination with pemetrexed Arm Label: Placebo and pemetrexed

    Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

    Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.


    Recruitment Information


    Status
    Recruiting

    Start date
    2014-03

    Last follow-up date
    2018-04 (Anticipated)

    Primary completion date
    2017-10 (Anticipated)

    Criteria

    Inclusion Criteria:

    • Men and women ≥ 18 years of age.
    • Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology
    • Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
    • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated CTCAE Grade 1 dyspnea) that is not amenable to drainage
    • Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
    • Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
    • Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
    • Elective or a planned major surgery while on study treatment
    • Radiation therapy to greater than 25% of the bone marrow
    • Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
    • Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
    • Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
    • Pregnant or breast feeding
    • Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
    • Patients who are taking medications that are strong inducers or inhibitors of CYP3A4


    Gender
    Both

    Minimum age
    18 Years

    Healthy volunteers
    No

    Administrative Data


    Organization name
    Threshold Pharmaceuticals

    Organization study ID
    TH-CR-415

    Sponsor
    Threshold Pharmaceuticals

    Collaborator
    EMD Serono

    Health Authority
    United States: Food and Drug Administration

    Health Authority
    United States: Institutional Review Board

    Sentiment: Strong Buy

  • strongbuy33 by strongbuy33 Jan 11, 2016 10:38 AM Flag

    Threshold Pharma and Merck KGaA (MKGAY) agree upon terms for the licensing

    Sentiment: Strong Buy

  • 6:29 am Threshold Pharma and Merck KGaA (MKGAY) agree upon terms for the licensing back of all rights to evofosfamide to Threshold (THLD) :

    Sentiment: Strong Buy

  • Explosive before Feb THLD will see Explosive to triple.......

    Sentiment: Strong Buy

  • before Feb THLD will see triple.......

    Sentiment: Strong Buy

  • I sold all, all in THLD before Feb THLD will see triple.......

    Sentiment: Strong Buy

  • Someone lace big order buying 800K shares, something good news out

    Sentiment: Strong Buy

  • strongbuy33 by strongbuy33 Jan 5, 2016 5:57 PM Flag

    See you guys 1 .32

    Sentiment: Strong Buy

  • sell now all in thld, this will below 0.50 soon, all in thld

    Sentiment: Strong Sell

  • I sold all this all in THLD, will see triple before Feb

    Sentiment: Strong Buy

  • Threshold Pharmaceuticals, Inc. THLD befoe Feb will see %500 move

    Sentiment: Strong Buy

  • The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

    Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. NSCLC is the most common type of lung cancer.“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”

    Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells. In 2014, Keytruda was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Another drug, Opdivo (nivolumab), manufactured by Bristol-Meyers Squibb, also targets the PD-1/PD-L1 pathway and was approved to treat squamous non-small cell lung cancer (a certain kind of NSCLC) in 2015.

    The safety of Keytruda was studied in 550 patients with advanced NSCLC. The most common side effects of Keytruda included fatigue, decreased appetite, shortness of breath or impaired breathing (dyspnea) and cough. Keytruda also has the potential to cause severe side effects that result from the immune system effect of Keytruda (known as “immune-mediated side effects”).

    The effectiveness of Keytruda for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multi-part study. The subgroup consisted of patients with advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR). This subgroup also had PD-L1 positive tumors based on the results of the 22C3 pharmDx diagnostic test. Study participants received 10 mg/kg of Keytruda every two or three weeks. The major outcome measure was overall response rate (percentage of patients who experienced complete and partial shrinkage of their tumors). Tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months.

    In the 550 study participants with advanced NSCLC, severe immune-mediated side effects occurred involving the lungs, colon and hormone-producing glands. Other uncommon immune-mediated side effects were rash and inflammation of blood vessels (vasculitis). Women who are pregnant or breastfeeding should not take Keytruda because it may cause harm to a developing fetus or newborn baby. Across clinical studies, a disorder in which the body's immune system attacks part of the peripheral nervous system (Guillain-Barre Syndrome) also occurred.

    The FDA granted Keytruda breakthrough therapy designation for this indication because Merck demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. The drug also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

    Keytruda was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. An improvement in survival or disease-related symptoms in patients being treated with Keytruda has not yet been established.

    Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc. in Carpinteria, California.

    The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco

    Sentiment: Strong Buy

  • Sold BEBE all in THLD, will get back all your lose, last chance, BEBE R/S 1st day 2016

    Sentiment: Strong Sell

  • Mask this THLD will double higher then GALE after today

    Sentiment: Strong Buy

  • Sold all this all in THLD, will see %300 after today

    Sentiment: Strong Buy

  • I sold out this all in THLD, after year %300 or more

    Sentiment: Strong Buy

NVS
74.33-0.73(-0.97%)Feb 5 4:02 PMEST