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in4thelonghaul

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  • Therapeutic Cancer Vaccines: From The Underwhelming To The Exciting [View article]
    Thanks Ted for always making certain Provenge efficacy is correctly reported....and of course in addition to the OS increase, Provenge provides an incredible 'quality of life' benefit - not to mention there appears a subset of recipients who respond phenomenally. With earlier use in the disease process who can say what efficacy stats may become evident in time. What a shame that Dendreon was so poorly managed for so many years.

    Besides NWBO and ONTY mentioned in the article, and the not mentioned IMUC & CLDX, another potentially promising under-followed dev. biotech is Advaxis (ADXS) with a measly MC of around $14 million; though not as far along, being only in P-2 for cervical cancer/CIN, they appear to be matching or exceeding best SOC but without the usual serious side effects of chemo.

    From their site:

    "Advaxis uses live, attenuated bioengineered Listeria monocytogenes as a therapeutic agent. We start with a live, attenuated strain of Listeria then add multiple copies of a plasmid that encodes a fusion protein sequence including a fragment of the LLO (listeriolysin O) molecule joined to the antigen of interest. This fusion protein is secreted by the Listeria inside the antigen presenting cells, and other cells, which has been shown to result in a strong stimulation of both the innate and adaptive arms of the immune system and a reduction in tumor defense mechanisms.

    And from YHOO Bus. Summary:

    "The company’s platform technology generates an immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor. It has approximately 19 distinct constructs in various stages of development, directly developed by the company and through strategic collaborations with recognized centers, such as the National Cancer Institute, Cancer Research-the United Kingdom, the Wistar Institute, and the University of Pennsylvania. The company’s immunotherapies in development stage include ADXS-HPV that is being evaluated for cervical intraepithelial neoplasia, cervical cancer, and head and neck cancer. Its immunotherapies in development stage also comprise ADXS-PSA for prostate cancer; and ADXS-HER2 for canine osteosarcoma, as well as for HER2 expressing cancers, such as breast, gastric, bladder, brain, pancreatic, and ovarian cancers."

    Looks like next ADXS cervical cancer efficacy indications won't be in until Q12013 at the earliest. An interesting aspect of the ADXS approach is that their treatment can be produced at a fraction of the cost of treatments such as Provenge. Just a heads up is all.
    Nov 22 05:50 PM | 1 Like Like |Link to Comment
  • Axion Power: A Battery Manufacturer Charging Forward [View article]
    Just my guess, but it strikes me as likely that Axion will seek additional operating capital well before end of Q1-2013.
    Nov 20 08:22 PM | 2 Likes Like |Link to Comment
  • Will Dilution Wash Out OCZ Technology Shareholders? [View article]
    Seems OCZ might be a good speculative buy at about 85 cents.
    Nov 20 07:12 PM | Likes Like |Link to Comment
  • With Share Offering Registration And Trial Enrollment Complete, Time To Buy MannKind [View article]
    IMUC won't have ICT-107 PII results out by the end of the year, not even interim results will be out until next year.
    Oct 18 11:45 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
    Nice rendition of the efficacy achievements to date for CLDX's Rindopeimut (CDX-110).

    My understanding is that NWBO's DCVax-L, in their phase-1 trial, has achieved 55% OS at 3 years...uncertain if they have 4 year survival stats. Somewhere I read that 50% (8 /16) recipients of IMUC's ICT-107 reached 4 year survival from their phase-1 trial...with 3 of those achieving over 5 year survival - but another read placed the 4-yr OS at 'only' 6 of 16, so I am uncertain as to the correct figures on this; maybe Larry can clarify if he chooses to respond. It does appear that CLDX has more 'trials under the belt' so to speak, so may have an easier time with the FDA assuming positive trial results are again delivered in the current Rindopepimut trials. Though CDX-110 ACT III trial results indicating 52% OS at 2 years is impressive, one has to wonder how this will eventually stack up against the 55% 3-year OS results achieved by IMUC and NWBO, not to mention ICT-107's 4-yr survival figures.....assuming such results can be proved out in further trials.

    CLDX is well funded, has sig. inst. ownership, proven technology and is further along with their pipeline than NWBO - ie., CDX-011, an antibody-drug conjugate in Phase IIb clinical trial for metastatic breast cancer and melanoma indication, among others. Of course CLDX has a MC sig. higher than the other two as well, and CDX-110 is apparently appropriate for ~ 40% of those afflicted with GBM...sig. less than the target population which DCVax-L is addressing - though one has to wonder about the difference in cost to produce/administer the different treatments.

    My impression is that IMUC's ICT-107 4 and 5 year OS stats surpass all the others to date...but then again the trial was small and their treatment may only be applicable to roughly 50% of GBM patients. I wonder, assuming IMUC's current P-2 trial appears to validate the astounding efficacy results achieved in the P-1 trial, if FDA may allow them to file directly without running a P-3 trial.
    Oct 6 03:07 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
    So that we are clear here....if one invests in a speculative dev. biotech and the s/p goes down instead of up - it is just soooo unfair and the company is just miserable? LOL What, are you 12 years old?
    Maybe SA should implement some type testing for minimal intelligence before granting posting rights.....or are you a comedian?
    Oct 6 01:57 PM | 2 Likes Like |Link to Comment
  • Promising Development-Phase Pharmas Leading The Fight Against Cancer [View article]
    So assuming a burn of about $2 M per/mo....then CLSN is down to about $18 M cash reserves, or about 9 months worth as of Oct. - sounds like the $5 M left on the loan facility isn't yet available. Of course they are expecting the HEAT trial to wrap up in December I believe...but then they will be down to approx. 6 months of operating capital, and then comes the time required for trial result tabulation. I am wondering if they may not be comfortable running that low on operating capital.
    Oct 4 07:42 PM | Likes Like |Link to Comment
  • Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
    Congrats on the prescient timing Larry -

    NWBO(D) share price just went vertical today, ending up almost 100% at $10.95 on only roughly 220,000 shares...apparently spiked briefly to $20 at one point! Market cap has a bit more than doubled in just a few days since the split. Guess now they can raise that $25 M at a much much nicer s/p.
    Sep 28 09:36 PM | 1 Like Like |Link to Comment
  • Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
    Nice article Larry -

    Often cancer treatments are approved which achieve only minimal increases in overall survival, sometimes on no increase in OS but improvements in quality of life due to lessened side effect profiles - yet here we have a pretty much still under the radar treatment, in P-3 trial, potentially increasing median survival in GBM by 3 fold (though trial endpoint is PFS as you indicated) from a company with a MC under $150 M...pocket change for big pharma! I abslolutely love the fact they have wisely persued the dual tract approval approach involving both US and European trial sites - brilliant insurance against the potential of obstructionist goalpost moving tactics the FDA has become so infamous for.

    Seems a bit unrealistic to speculate that the cost of treatment might be equivalent in the US, Europe and rest of world... if one even reduces your s/p target estimate by 50%, which I do, the upside is still just amazing grand slam potential.

    I would be interested in the differece between cost of manufacturing DCVax-L vs IMUC's ICT-107...my guess is the tumor lysate approach cuts well into the profit margin potential. From your article it is clear that approx. 90% of GBM patients who undergo surgery will provide sufficient tumor for 3 years worth of vaccine....what about boosters for those who may live 4 and 5 years? My understanding is that from the 16 patient phase-1 trial, IMUC's vaccine has at least 6...maybe 8, (of 16) recipients who have lived for over 4 years with 3 of those achieving 5 year survival - so I had the impression that ICT-107 was in the lead as regards OS...of course there is that seeming detail which may limit IMUC's treatment to only about half the overall target population.

    As regards durability/storage...is there a marked difference regarding 'shelf life' btwn the two - for instance does one or both of these treatments need to remain refrigerated following production?

    *Interesting trading today immediately following the R/S....only roughly 10,000 shares traded, at least that we are privy to, with a 20% s/p appreciation! You mentioned the ' up to' $25 million capital raise upcoming....so maybe 6 million shares at $4?? Obviously the tutes weren't stampeding into Northwest today, but they sure weren't shorting it either. Considering the potential, the wise dual tract P-3 trial approach, and the inherent platform technology...astounding that BP hasn't just made them an offer already.

    Thanks for shedding a bit more light on Northwest Bio....for everyone involved, investors and patients - hopefully DCVax-L turns out to be even more effective than the P-1 trials suggest.
    Sep 26 11:00 PM | Likes Like |Link to Comment
  • ICT-107 Into Perspective: Part 2 [View article]
    Thanks Brian for all your efforts re. IMUC - truly you have gone the extra mile with this one.

    Looking forward to the updated article/interview when it is cleared for publication and any insights you have regarding NWBO as well.
    Aug 31 04:12 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics' DCVax Cancer Vaccines Could Lead To A Sea Change In Cancer Treatment [View article]
    Makes perfect sense to me - brilliant move if one has complete confidence in the likelihood of replicating stunning efficacy achieved in phase-1 trial....of course the concurrent European efforts is a very nice insurance policy when one is dealing with the FDA which allows them to more comfortably make such a jump. If you don't understand this, you don't understand the FDA reputation for absurd obstructionist, goal-post moving, treachery. Seems likely as well that NWBO will R/S at 6:1 or greater, and then dilute to raise money - waiting and watching as I expect one may be able to acquire shares at a 40 to 50 percent reduction with luck.
    Aug 23 10:00 PM | Likes Like |Link to Comment
  • Taking A Flyer On This Cash-Rich Biotech With Recent Insider Buying [View article]
    SQNM mngt. definately doesn't act as a group which is worried about competition - instead they act as though they expect sales to continue to beat their guidance, or they are pretty confident that another major provider is close to signing on...or both.
    Aug 15 11:10 AM | Likes Like |Link to Comment
  • A123 Systems: An Object Lesson In Toxic Financing [View article]
    Thanks John - not another author on SA I look forward to reading more than you.
    Aug 6 12:13 PM | 7 Likes Like |Link to Comment
  • Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
    Ted, excellent response......always with such class.

    Who knows what comes along in that extra avg. year of quality life, life free from the terrible ravages of chemo.....one never knows who the lucky outliers will be which live for many years after Provenge treatment. I truly believe that the onco docs are only now even beginning to realize the true potential of Provenge administered at optimum times for best true efficacy - I look forward to the synergies which will be achieved as Provenge is combined with other new treatments soon to be available.
    Jul 25 09:56 PM | 2 Likes Like |Link to Comment
  • Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
    MoneyHawk -
    Proven is not chemo.....not surprised you have made only 2 comments!

    A subset of individuals, individuals with advanced unresponsive prostate cancer who have on average about 18 months to live - this subset of persons receive tremendous benefit from Provenge treatment...they have been known to recover and live for 6 or 7 years!

    Imagine you have the choice of ineffective chemo which makes you so sick you likely despair of living anyway, or receiving Provenge which has only very mild transitory side effects like a mild case of the flu - and possibly living for years further.

    Guys at death's door, treated with Provenge, often feel so good once it kicks in they resume playing golf! Of course Provenge given earlier in the disease process, before chemo has about destroyed the immune system, will only increase the size of that recipient subset who live additional years. Now combine Provenge with another miracle treatment and you are likely to achieve the equivalent of complete remission.....think about it, try and educate yourself a bit, then engage brain before opening mouth - it works so much better that way and people don't laugh at you then.
    Jul 25 04:21 PM | 5 Likes Like |Link to Comment
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