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fezziwig2008

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  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    You are the most consistent short voice on the Halozyme Yahoo message board and are,therefore, very unlike your narrative which is inconsistent. The US patent on the Roche agents in question do not expire for 3 years.
    Dec 20, 2014. 03:18 PM | Likes Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    $IMGN and $RHHBY's loss is $HALO's gain- Herceptin and Taxol as effective as Kadcyla and Perjeta? Which government or 3rd party payer will lay out $94,000 a year for a drug no better than a generic combination. Only Herceptin SC is superior to Herceptin IV for ALL 3rd party payers and government single payers because it delivers noninferior effect to Herceptin IV at a much lower cost. The "5 minute jab" described in British tabloids will do more to save millions of pounds, Euros, and in 3 yrs dollars than any "me too" IV version. The delivery of subcutaneous Herceptin at home is invaluable to cancer patients. Thanks to Halozyme- that is where their product is being delivered by the patients themselves. Everyone profits- except IMGN.
    Dec 20, 2014. 03:13 PM | 2 Likes Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    I believe $HALO was partnered first and foremost for Enhanze patent extension and Biosimilar defense of Remicade- $7B Revenue- #8 on the 2013 top 100 drugs by revenue list.
    Dec 20, 2014. 03:02 PM | Likes Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    SPA-
    Yes this is a pilot study, but that means it will be completed during 2015. Since it's being done by 2 oncologists at Sloan Kettering- including world renowned Eileen O'Reilly, the pathology of the pancreas specimen treated with pegpH20 will be the first not generated by HALO. Medicine will take note of the tumor architecture with hyaluronan removed- a shriveled grape
    Heard 'round the world. Erbitux may or may not work but the pathology us key. Besides it is best for HALO if mFolf works best with reduced side effects - it will be a wholly owned HALO product.
    Dec 9, 2014. 11:00 PM | 1 Like Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    Small Pharma Analyst- 2 points on the Phase 2 PegpH20 trials. The Modified Folfifnox (less 1 5 FU Infusion for better tolerability) Trial is importantly being funded by NCI and sponsored by SWOG. Halozyme will have the patent on the combination of PegpH20-mFolfifnox without the expense. Secondly, there is another Ph2 studying Erbitux and pegpH20 at MSKCC. Importantly, pathology will be studied and the small trial should be completed by
    sept 15:

    Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
    This study is currently recruiting participants. (see Contacts and Locations)
    Verified September 2014 by Memorial Sloan-Kettering Cancer Center
    NCT02241187
    Sponsor:
    Memorial Sloan-Kettering Cancer Center
    Collaborator:
    Cold Spring Harbor Laboratory
    Information provided by (Responsible Party):
    Memorial Sloan-Kettering Cancer Center
    Experimental: PEGPH20 And Cetuximab
    5 participants will be consented to undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. DW- & DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will undergo DW- & (DCE)-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. DW- & DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later. Blood samples will be drawn at various time points.
    Dec 9, 2014. 08:49 PM | 1 Like Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    ASCO Accepted the data for their Prestigious GI Meeting - your fear mongering is old news in spite of your new handle.
    Dec 9, 2014. 08:26 PM | 2 Likes Like |Link to Comment
  • Halozyme Therapeutics - Buy The Drug Delivery Platform And Get A Cancer Drug For Free [View article]
    Excellent summary - Halozyme is mispriced because casual observers
    Don't realize the significance of Sept 13 data and the subsequent effect it had on one if Amgen's rising stars. Helen Torley left AMGN for ONXX where she's Launched Kyprolis then returned to Amgen with it. She then saw that impressive pegpH20 data -as well as the Sept, Oct, and Nov data we haven't seen yet-and left the safety of her long successful career with a Biotech leader for PegpH20. She stated same at the Q3 2014 earnings call. She accepted options @ $14 and has bought recently. That must be impressive data...
    Dec 9, 2014. 12:44 PM | 6 Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]
    Leonard Saltz, MD Chief, Gastrointestinal Oncology Service; Head, Colorectal Oncology Section Memorial Sloan Kettering Cancer Center criticized - in the NEJM-the cost benefit ratio of Abraxane over paclitaxel adding only 1.8 mos at high cost-
    "The article by Von Hoff et al. (Oct. 31 issue)1 is entitled "Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine." This title strikes us as inappropriately rosy, given the modest benefits and substantial toxic effects observed. The addition of nab-paclitaxel increased the median survival by 1.8 months, or 55 days. The chance of being alive at 2 years was increased from 4% to 9%. Meanwhile, an additional 10% of patients had grade 3 (severe) fatigue. Grade 2 fatigue (moderate, not relieved by rest) and duration of fatigue are not mentioned. Grade 3 (severe) neuropathy was increased by 16%. No data on grade 2 (moderate) neuropathy are presented. No data on the out-of-pocket costs of the nab-paclitaxel are provided, even though negative financial consequences represent another source of "toxicity" and a driver of bankruptcies. In this study, the incremental cost of nab-paclitaxel was around $25,000 on the basis of Medicare reimbursement rates. A more neutral title, such as "Nab-Paclitaxel plus Gemcitabine in Pancreas Cancer," might help avoid an imbalanced perception of the study findings."
    How interesting that MM-398 Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) announced that the combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone, I'll let Dr Saltz's word spesk for themselves regarding
    "MM-398 - a nanoliposomal encapsulation of irinotecan, allowing for the drug to stay in circulation for a longer duration compared with standard irinotecan". resulting in an additional 1.9 mos of survival.
    Dec 6, 2014. 10:22 AM | Likes Like |Link to Comment
  • Weekend Events May Spark New Ebola Front-Runner  [View instapost]
    A Very balanced and accurate assessment of the situation- Thanks.
    Oct 25, 2014. 11:37 AM | Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]

    The 2 arms that I compare are single agent Irinotecan therapy- 1 encapsulated , one not-in the same population.
    You refer on my instablog( http://seekingalpha.co...) to MACK's Pancreatic Cancer 4b patients as "Sicker" in some way- a way you never specify with scientific data-than the patients in the Phase 2 single agent Irinotecan trial, who were pancreatic cancer stage 4b, who also failed gemcitabine primary therapy, and who also were dying. The only obvious difference between the two populations is that the unencapsulated irinotecan treated patients had a median overall survival of 6.6 months with no help from 5FU and Leucovorin, while under the same circumstances, the Nanoparticle encapsulated (MACK's) patients had an MOS of only 4.9 months. Even with the assistance of 5FU and leucovorin, this value only increased to 6.1.
    You ignore the fact that MM 398 had higher rates of Adverse effects than both the combination studied and the nonencapsulted arm. You discount as worthless a paper I cite on the possible adverse effects of nanoparticle delivery inherent in the "carrier system"- http://1.usa.gov/1rrSyet yet you provide no scientific evidence to support your dismissal.
    Instead you Name Drop- and Unfortunately for you, you dropped the wrong name this weekend, as Adam Fuerstein's treatment of biotech data is being questioned in the Washington Post as being unfairly skewed suggesting an agenda that has little to do with science.
    Here's the link-I like to back up my claims-

    http://wapo.st/1vo0kYo

    Finally, the MM 308 dependence on Leucovorin may also prove to be a problem, as there is a national shortage currently-

    http://bit.ly/1rwHPAH
    Sep 29, 2014. 01:23 AM | Likes Like |Link to Comment
  • MM 398 From Merrimac Pharma- The Emperor's New Pancreatic Cancer Therapy $MACK $CELG $HALO [View instapost]
    You continue to refer to MACK's Pancreatic Cancer 4b patients who failed Gemcitabine Primary Treatment and , who are, therefore dying as Sicker in some way- a way you never specify with scientific data-than the patients in the Phase 2 single agent Irinotecan trial, who were pancreatic cancer stage 4b. They too failed gemcitabine primary therapy. The only obvious difference between the two populations is that the unencapsulated irinotecan treated patients had a median overall survival of 6.6 months with no help from 5FU and Leucovorin, while under the same circumstances, the Nanoparticle encapsulated (MACK's) patients had an MOS of only 4.9 months. Even with the assistance of 5FU and leucovorin, this value only increased to 6.1.
    So, the only thing obvious to me about your assertions is that they are strongly worded to fit your case without scientific data. In other words, "full of sound and fury signifying" not very much. Go back to the drawing board and find some evidence the the encapsulated group was sicker than the unencapsulated one, or stop writing it.
    Oh, and by the way- the dependence on Leucovorin might pose a problem for MM-398, as there is currently a national shortage.

    Evidence to back up my assertion:

    http://bit.ly/1rwHPAH
    Sep 29, 2014. 12:23 AM | Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]
    So MM398 ISN'T Irinotecan, it's Nanoparticled, Encapsulated Irinotecan- yes I know- So It should THEREFORE be SAFER and MORE effective - correct? That's the purpose - this modification is NOT being done for commercial reasons- to market a patented form of Irinotecan- correct? Then PLEASE explain these Findings from 2009- Regular old Irinotecan used in the same setting with far superior and safer results.

    6.6 mo MOS in Ph2 2009 Irinotecan UNencapuslated Study after Gemcitabine Failure in Metastatic Pancreatic - Superior to MM 398 - 4.9 mo MOS by itself in same setting and only 6.1 with the help of 5FU and Leucovorin-

    Cancer Chemother Pharmacol. 2009 May;63(6):1141-5. doi: 10.1007/s00280-008-083... Epub 2008 Oct 7.
    Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer.
    Yi SY1, Park YS, Kim HS, Jun HJ, Kim KH, Chang MH, Park MJ, Uhm JE, Lee J, Park SH, Park JO, Lee JK, Lee KT, Lim HY, Kang WK.
    Author information
    Abstract
    PURPOSE:
    The phase II study was conducted to evaluate the efficacy and safety of irinotecan as salvage single-agent chemotherapy in patients with advanced pancreatic cancer.
    METHODS:
    Patients with measurable metastatic pancreatic cancer, progressive after previous gemcitabine-based chemotherapy were treated with irinotecan 150 mg/m(2) every 2 weeks. Treatment was repeated until disease progression or unacceptable toxicity.
    RESULTS:
    Between March 2004 to February 2007, 33 patients were registered and treated with irinotecan monotherapy. The patients' median age was 59 years (range 36-70) and two had an ECOG performance status of 2. A total of 167 chemotherapy cycles were delivered (median, 4; range 2-12). In an intent-to-treat analysis, three (9%) confirmed partial response and 13 patients with stable disease were observed for a disease control rate of 48%. The median progression-free and overall survivals were 2.0 months (95% CI, 0.7-3.3) and 6.6 months (95% CI, 5.8-7.4), respectively. Toxic effects were mainly gastrointestinal (nausea in 64% of patients, diarrhea in 36%), Toxicity profiles were generally predictable and manageable, and there was no treatment-related death.
    CONCLUSIONS:
    Second-line chemotherapy with single-agent irinotecan is marginally effective and well tolerated regimen for gemcitabine-pretreated patients with advanced pancreatic cancer.
    Sep 28, 2014. 11:18 AM | Likes Like |Link to Comment
  • MM 398 From Merrimac Pharma- The Emperor's New Pancreatic Cancer Therapy $MACK $CELG $HALO [View instapost]
    Stop the Presses- 6.6 mo MOS in Ph2 2009 Irinotecan UNencapuslated Study after Gemcitabine Failure in Metastatic Pancreatic - Superior to MM 398 - 4.9 mo MOS by itself in same setting and only 6.1 with the help of 5FU and Leucovorin-

    Cancer Chemother Pharmacol. 2009 May;63(6):1141-5. doi: 10.1007/s00280-008-083... Epub 2008 Oct 7.
    Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer.
    Yi SY1, Park YS, Kim HS, Jun HJ, Kim KH, Chang MH, Park MJ, Uhm JE, Lee J, Park SH, Park JO, Lee JK, Lee KT, Lim HY, Kang WK.
    Author information
    Abstract
    PURPOSE:
    The phase II study was conducted to evaluate the efficacy and safety of irinotecan as salvage single-agent chemotherapy in patients with advanced pancreatic cancer.
    METHODS:
    Patients with measurable metastatic pancreatic cancer, progressive after previous gemcitabine-based chemotherapy were treated with irinotecan 150 mg/m(2) every 2 weeks. Treatment was repeated until disease progression or unacceptable toxicity.
    RESULTS:
    Between March 2004 to February 2007, 33 patients were registered and treated with irinotecan monotherapy. The patients' median age was 59 years (range 36-70) and two had an ECOG performance status of 2. A total of 167 chemotherapy cycles were delivered (median, 4; range 2-12). In an intent-to-treat analysis, three (9%) confirmed partial response and 13 patients with stable disease were observed for a disease control rate of 48%. The median progression-free and overall survivals were 2.0 months (95% CI, 0.7-3.3) and 6.6 months (95% CI, 5.8-7.4), respectively. Toxic effects were mainly gastrointestinal (nausea in 64% of patients, diarrhea in 36%), Toxicity profiles were generally predictable and manageable, and there was no treatment-related death.
    CONCLUSIONS:
    Second-line chemotherapy with single-agent irinotecan is marginally effective and well tolerated regimen for gemcitabine-pretreated patients with advanced pancreatic cancer.
    Sep 28, 2014. 08:24 AM | Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]
    Obviously, the Adverse effects of MM-398 (Iriniotecan) were significantly Higher than those of FolF(Iri)- what accounts for that? Did the manipulation of the Folfirinox regimen with the best of intentions- to reduce AE's and increase Median Overall Survival- actually do just the opposite? Folfirinox as a primary Rx for Pancreatic Cancer Stage 4b has an 11.1 MOS- Gem as primary has a 4.7 mo MOS and MM398 adds 6.1, Doesn't that fall short? One explanation for the INCREASED AEs over Folf(Iri) is found below. This is all Ph3 data, so by your standards, you can't ignore it.

    http://1.usa.gov/1rrSyet

    International Journal of Nanomedicine

    Dove Press

    Drug delivery and nanoparticles: Applications and hazards

    Wim H De Jong and Paul JA Borm

    Additional article information

    Abstract

    The use of nanotechnology in medicine and more specifically drug delivery is set to spread rapidly. Currently many substances are under investigation for drug delivery and more specifically for cancer therapy. Interestingly pharmaceutical sciences are using nanoparticles to reduce toxicity and side effects of drugs and up to recently did not realize that carrier systems themselves may impose risks to the patient. The kind of hazards that are introduced by using nanoparticles for drug delivery are beyond that posed by conventional hazards imposed by chemicals in classical delivery matrices.

    You can read the rest of the peer reviewed article you referred to as "one man's opinion" on my blog, despite the listing two authors. It seems that's about as accurate as you get, with just as much scientific evidence.
    Sep 27, 2014. 07:17 PM | Likes Like |Link to Comment
  • MM 398 From Merrimac Pharma- The Emperor's New Pancreatic Cancer Therapy $MACK $CELG $HALO [View instapost]
    "Please think carefully about whether you are qualified"
    Read this first- "One Person"???

    International Journal of Nanomedicine

    Dove Press

    Drug delivery and nanoparticles: Applications and hazards

    Wim H De Jong and Paul JA Borm

    Abstract

    The use of nanotechnology in medicine and more specifically drug delivery is set to spread rapidly. Currently many substances are under investigation for drug delivery and more specifically for cancer therapy. Interestingly pharmaceutical sciences are using nanoparticles to reduce toxicity and side effects of drugs and up to recently did not realize that carrier systems themselves may impose risks to the patient. The kind of hazards that are introduced by using nanoparticles for drug delivery are beyond that posed by conventional hazards imposed by chemicals in classical delivery matrices.

    http://1.usa.gov/1rrSyet

    Then explain the HIGHER rates of Adverse Effects with MM-398 (encapsulated Irinotecan) than with FolF(IRI). Isn't the Nanoparticle process intended to DECREASE AEs?

    Then Explain how Merrimack's Pancreatic 4b patients who failed Gem are "much sicker" than anyone else's.

    Yes, I believe you have much to evaluate- like your ability to impartially judge peer reviewed science in light of your position.
    Sep 27, 2014. 07:06 PM | Likes Like |Link to Comment
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