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Research Background- I only invest in areas of interest that are familiar.
  • Halozyme To Control Pancreatic Cancer With PegpH20-MFolfirinox CRADA 2 comments
    Nov 19, 2013 8:24 PM | about stocks: HALO

    According to the Dept of the Interior, a CRADA or Cooperative Research and Development agreement is designated under the Federal Technology Transfer Act of 1986 (P.L. 99-502) (which amended the Stevenson-Wydler Technology Innovation Act of 1980 (P.L. 96-480)), a CRADA is intended to speed the commercialization of technology, optimize resources, and protect the private company involved. A CRADA allows both parties to keep research results confidential for up to five years under the Freedom of Information Act. The Office of Scientific and Technical Information (OSTI) is responsible for preserving the scientific and technical information generated through a CRADA and making this information readily available to the scientific community as well as the public.[3]

    Private corporations participating in a CRADA are allowed to file patents, and they retain patent rights on inventions developed by the CRADA. The government gets a license to the patents.[4]

    How interesting, when one goes to ClinicalTrials.Gov and finds this:

    S1313, Phase IB/II Randomized Study of MFOLFIRINOX + PEGPH20 Vs MFOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma

    This study is not yet open for participant recruitment.

    Verified October 2013 by Southwest Oncology Group

    Sponsor:

    Southwest Oncology Group

    Collaborators:

    National Cancer Institute (NYSE:NCI)

    Halozyme Therapeutics

    Information provided by (Responsible Party):

    ClinicalTrials.gov Identifier:

    Southwest Oncology Group

    NCT01959139

    The National Cancer Institute is allowing Halozyme to participate in a CRADA on the most promising generic combination to attack pancreatic cancer to date. The previous gold standard, Gemcitabine, had its 7 mo survival numbers increased by 1.5 months by the addition of Celgene's Abraxane. This resulted in FDA approval of Abraxane for this indication. in 2011, FOLFIRINOX provided the best survival time ever reported in metastatic pancreatic cancer. Overall survival was significantly better with FOLFIRINOX than with gemcitabine (11.1 vs 6.8 months; P < .0001). However toxicity remains a problem, with many community oncologists sticking to Gem-Abraxane as first line treatment in metastatic Pancreatic CA. 11.1 mos is approximately 338 days. The reason I break it down is to highlight that Pancreatic cancer has a high prevalence of high hyaluron concentration, with many researches implicating hyaluron as a necessary support for metastasis. Well in the high hyaluron group of the PegpH20-Gemcitabine data presented at ESMO this past September, the running time on survival was 529 days and counting. In fact, HALO is still counting as at the Credit Suisse Healthcare Meeting, HALO's CEO shared that the data is "still not mature". At ASCO in April, there were 5 survivors, 6 months later there are 4.

    Most exciting was the Complete Biochemical Response- total normaization of Pancreatic cancer tumor marker CA19-9 in one patient (007-414).

    Now, combining PegpH20 with a Folfirinox protocol modified to reduce toxicity by leaving out a 5 FU infusion, and owning the resulting product is, my view the most exciting of Halozyme's many projects.If PegpH20 can more than double Gemcitabine survival numbers, what will it do for much more powerful Folfirinox? It may, in fact lead to advances in the treatment of other high hyaluron tumors-such as Breast, Ovarian, Bladder, and Prostate. Halozyme's Ceo summarizes the process best below:

    "Nobody else is taking this approach to the cancer," explained Dr. Frost. "When we first started, people thought we were crazy, thought we would make the tumor spread and explode. Now we are somewhere between people thinking this is crazy and thinking this is the obvious solution."

    It's marvelous that the United States Government, in issuing Halozyme a CRADA on PegpH20-mFolfirinox acknowledges that should this be "the obvious solution" Halozyme and its stockholders will own it.

    Disclosure: I am long HALO.

    Stocks: HALO
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  • fezziwig2008
    , contributor
    Comments (108) | Send Message
     
    Author’s reply » PegPh20 IS ramping Up for 2nd Site- Probably Breast- Probably with Abraxane- Abraxane Stalled in Breast CA- Insurers Balking
    .
    CELG competes with generic paclitaxel in Breast Cancer Rx, and MDs such as Leonard Saltz in the NE J of Med have questioned openly the added cost- Insurers have already put more requirements on its use- in the CELG Q4 CC Rachel McMinn the Bank of Am Analyst Questioned if there would be ANY growth of Abraxane in Breast Cancer this year- Celgene needs help with their $3B investment in Abraxane. I believe Celgene is waiting to see $halo Peg Data on Pancreatic and Breast Cancer before trying to acquire at least its exclusive rights for these indications- if not more. THAT's why the $100m secondary offering was needed Now- poorly timed? not at all- Iron is Hot.
    5 Feb, 01:38 PM Reply Like
  • fezziwig2008
    , contributor
    Comments (108) | Send Message
     
    Author’s reply » In the starburst scenario, in which $halo is broken up into its parts, with Enhanze sold to RHHBY, Rights to Peg-Abraxane to CELG, Insilin to LLY, and HTI to AGN, HALO will become what it was originally intended to be- an Oncology Company. The Folfirnox CRADA would then be expanded past Pancreatic CA and applied to multiple indications- first and foremost ColonCA.
    13 Feb, 12:27 PM Reply Like
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