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Affymax, Inc. (AFFY) Message Board

dinepat203 1719 posts  |  Last Activity: 13 hours ago Member since: Sep 29, 2011
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  • Adam Feuerstein ‏@adamfeuerstein
    Who’s throwing the biotech party tonight? May be NWBO.

  • The randomized phase III trial of DCVax-L in glioblastoma multiforme will enroll 300 patients in the US, Germany and the UK with topline results expected in late 2013 or early 2014. The primary endpoint is median time to progression and patients who progress in the control arm will be switched to DCVax-L. This is similar to the original design of the Provenge phase III trial. Provenge did not successfully reach the time to progression endpoint, but it did show a statistically significant improvement in median overall survival and this ultimately led to its approval. The improvement in overall survival was achieved even though the patients in the control arm also received Provenge once their disease progressed.

    Because of the similarities of the DCVax-L trial design to that of Provenge, there will be a lot of fretting as to whether DCVax-L will be successful. There will also be concern because the FDA has signaled that it prefers to see a survival benefit in cancer trials and often requires two separate, confirmatory trials for approval. These FDA issues raise the concern that even if the endpoints of the trial are successfully reached that the FDA may require another supporting phase III trial.

    These are legitimate concerns, but the experience with Avastin gives hope. Avastin was studied in GBM patients who had failed standard of care. There were 134 patients evaluated in two non-randomized trials. In 2009, the FDA was willing to approve Avastin for GBM based only on very modest progression free survival of about 4 months and with no evidence of an effect on survival. Note that the DCVax-L trial adds DCVax-L to first line standard of care while Avastin was used in sicker patients who had failed SOC.

  • dinepat203 dinepat203 14 hours ago Flag

    Asymmetric investing does not mean that an investor is smart enough to predict with certainty clinical trial outcomes. The premise is that the event has a reasonable chance of occurring, is unexpected and if it does occur the upside potential dramatically offsets the risk of losing much or all of the investment if the outcome is negative.

    The approach I have used to gage potential upside for Northwest is to compare it to two other cancer targeted biotechnology companies that have drugs in similar stages of development. If the phase I results for DCVax-L are repeated in the phase III trial, it will be a great breakthrough for treating glioblastoma multiforme. In addition, it will validate the dendritic cell approach for the treatment of most solid tumors. I believe that the market would respond to this event in the same way that it has reacted to Pharmacyclics results with ibrutinib in hematological cancers which has resulted in an increase in market capitalization from $500 million to $4 billion over the last year. With the 430 million fully diluted shares for Northwest that I project for 2014, this would result in a price of about $9.00.

    This is an obvious best case. In the event that the results are positive, but show more modest improvements, I think that the example of Threshold Pharmaceutical with TH-302 might be a good model, When results showed modest objective responses and modest improvement in progression free survival in pancreatic cancer, the market capitalization jumped from $77 million to $450 million. At $450 million, Northwest would sell for about $1.00 per share.

    Of course, the phase III trial could fail. There is ample evidence of trial failures in biotechnology and especially in cancer vaccines where very promising phase I results are not replicated in phase III trials. There is a very real risk that if this occurs with DCVax-L that Northwest would fail. Anyone investing in Northwest must be prepared to lose all of their money. My asymmetric analysis suggests that an investor is risking at most $0.22 to see an upside of as much as $9.00 in an optimistic case and perhaps $1.00 in a positive but more subdued case. Don’t ask me to assign odds for each scenario. I just think that there is a reasonable chance for success in which case the upside is so significant that this risk is justified.

  • dinepat203 dinepat203 14 hours ago Flag

    Fraunhofer and King’s College Collaborations Put Me over the Top

    I was intrigued with the phase I data and the superior manufacturing process, but I kept thinking what am I missing? It is not comforting to like a company that everyone else seems to be indifferent to or negative on. Understanding Northwest’s collaborations with Fraunhofer Institute and Kings College London and King’s College Hospital provided third party validation and gave me the investment courage necessary to push me over the top and go out with a Buy. I thought that if these two prestigious and knowledgeable institutions were willing to team up with Northwest that I might be on to something.

    Fraunhofer is a prestigious and well respected research institute in Germany that over 60 years has gained a reputation for advancing science in healthcare and many other areas. Kings College Hospital is the premier teaching hospital in London and serves a catchment area in the U.K. of 4.9 million patients. King’s College London is a sister institution that does contract manufacturing and has expertise in production of living cell products.

    I think that the Fraunhofer and the King’s College collaborations bring to Northwestern’s European development efforts the same benefits for manufacturing, clinical trial support and interaction with regulatory agencies that small companies look for when they partner with a big pharma company. Importantly, these collaborations do not produce the significant dilution to shareholders caused by sharing profits with a pharma partner. Northwest also does not risk losing control over product development if the big pharma company moves too slowly or becomes distracted, a not uncommon occurrence. These unique and highly valuable collaborations are a critical aspect of Northwest that investors have overlooked.

    The two manufacturing operations of Fraunhofer and King’s College London provide significant benefits. Because the manufacturing process is so crucial to the product,

  • The vaccine involves purifying a patient’s dendritic cells from a blood draw. These cells help to direct the entire immune system. Once activated with proteins from a patient’s own tumor, the dendritic cells are returned to the patient as a vaccine work to recruit and mobilize other cells against the cancer cells. The dendritic cells direct the immune system to specifically attack the cancer cells, without the toxicity or side effects of chemotherapy.

    In Phase I trials, median survival for patients receiving the vaccine was 33.8 months, and median time to recurrence was more than two years, compared with 6.9 months with standard care. Of patients receiving the vaccine, 33 percent reached four-year survival, 27 percent reached six-year survival, and the longest surviving patient to date exceeds 10 years.

    “I don’t think this is going to work for everybody,” Dr. Miller said. “But for the people who it has worked, it’s worked phenomenally. If we’re able to figure this out a little bit more and refine it, it could really be a game changer for treatment of GBM.”

    Stephanie Wagner, MD, is an associate professor of clinical medicine at Indiana University School of Medicine and co-medical director of the neuro-oncology program at Indiana University Health. Dr. Wagner uses a multi-disciplinary approach to create new treatment protocols for patients with brain tumors who need urgent intervention to halt the spread of cancer. She is a member of the Society of Neuro-Oncology, the American Society of Clinical Oncology and the American Society of Hematology. Dr. Wagner is a graduate of Ross University School of Medicine. She completed her internship and residency training at the James Graham Brown Cancer Center in Louisville, KY and another in neuro-oncology at Duke University’s Robert Tisch Brain Tumor Center in Durham, NC.

    James Miller, MD, is assistant professor of neurological surgery at Indiana University School of Medicine in the Department of Neurological Surgery. He is

  • dinepat203 dinepat203 14 hours ago Flag

    In the past, most clinical trials focused on recurrent GBM. Given that there is recurrence in nearly all cases, the lack of alternative therapies was frustrating for physicians and patients alike. Today, a number of trials are focused specifically on the newly diagnosed, and IU Health is playing a key role in bringing these therapies to patients. In addition to the DCVax-Brain study, this summer IU Health will begin offering newly diagnosed GBM patients another vaccine therapy, as well as study that inhibits TGF-beta.

    Researchers are also exploring the effect of multi-targeted therapies on GBM, and a number of clinical trials are focused on how these new drugs might aid the newly diagnosed. “Historically, GBM has been treated with surgery, radiation, more surgery, more radiation. But the therapies were behind the times because they were more localized therapies and didn’t treat the disease in a systemic fashion,” Dr. Wagner said. “I think we have been naïve in thinking that single-agent therapy will work on a tumor that has multiple growth pathways. The wave of the future is multi-targeted therapy and tailoring one’s treatment based on molecular markers.”

    One such therapy is bevacizumab, the only drug approved for GBM patients in the last decade. Bevacizumab works by targeting blood vessels and blocking cells that are important for cancer cell growth. Because it targets only those cells important to tumor growth, the drug spares healthy tissue and results in fewer side effects. The FDA approved bevacizumab in 2009 for treatment of recurrent GBM, making it the first antiangiogenic therapy approved for cancer patients.

    Bevacizumab is routinely prescribed for patients with recurrent disease, and now researchers think there is potential benefit for newly diagnosed patients, as well. Three phase II studies have shown that bevacizumab in the newly diagnosed patient increases progression-free survival, though its impact on overall survival remains to be determined. In a

  • dinepat203 dinepat203 14 hours ago Flag

    Ms. Powers reiterated that the Phase III trial is progressing well, and further centers of excellence are joining the trial.

    The Company urges investors, analysts and other interested parties to view Ms. Powers' presentation (which is available via webex on the Company's website) to hear the correct, positive information and form their own opinions.

  • dinepat203 dinepat203 15 hours ago Flag

    The Street themselves published this article.

  • As Ms. Powers conveyed in her March 27 presentation (and prior presentations), the key to successful trials and regulatory approvals is strongly powered trial results. The Company has shaped it Phase III trial design in order to provide strong powering, reduce risks, and provide cushions. An increase in patient numbers is simply another way to enhance the cushion relating to the p value – and thereby further reduce risks and make it easier for the trial to succeed.

    "We can only conclude that Feuerstein and those with whom he is allied are disturbed by NW Bio's continued and increasing strong progress in all of its programs," commented Linda Powers, CEO of NW Bio. "We note that his attacks seem to regularly coincide with positive NW Bio news and with substantial short seller activity. Perhaps they are all just coincidences."

    "Feuerstein's long history of false and unfounded attacks on NW Bio is directly contrary to the major validations we have received and continue to receive from leading medical institutions, and the most demanding regulatory agencies and health care authorities. We encourage investors, analysts and other interested parties to take a close look at these validations, compare them to Feuerstein's ongoing attacks, and form their own opinions about whom to believe."

  • Reply to

    could go above 6 dollars today?

    by louie9grpi 15 hours ago
    dinepat203 dinepat203 15 hours ago Flag

    How about $8 ?

  • Reply to

    Why YAHOO FINANCE is not showing Today's News ?

    by dinepat203 Apr 15, 2014 8:00 PM
    dinepat203 dinepat203 Apr 15, 2014 8:01 PM Flag

    NW BIO CLOSES ON FIRST $15 MILLION OF FINANCING FOR SUBSTANTIAL EXPANSION OF EUROPEAN PRODUCTION CAPACITY

    Tue Apr 15, 2014 1:11pm EDT

  • Yahoo Finance heavily bribed by the Short SELLERS ?

  • Reply to

    Great Great News!

    by bagholderzunite Apr 15, 2014 2:33 PM
    dinepat203 dinepat203 Apr 15, 2014 2:42 PM Flag

    Idiot doesn't know what is PEI approval...You looks like ADAM FKstein

  • Reply to

    $$$$$$$$$$10 OR MORE

    by dinepat203 Apr 15, 2014 2:29 PM
    dinepat203 dinepat203 Apr 15, 2014 2:31 PM Flag

    European programs, substantial additional DCVax-L production capacity - Linda F. Powers, with an increasing number of patients, including early access patients outside of our clinical trials involving some initial early revenues.

  • dinepat203 by dinepat203 Apr 15, 2014 2:29 PM Flag

    PR is out ...

  • Reply to

    Breaking just out !!!!!!!!!!!!!!!!!!!!!!!

    by dinepat203 Apr 15, 2014 2:05 PM
    dinepat203 dinepat203 Apr 15, 2014 2:18 PM Flag

    "With the recent positive developments in our European programs, substantial additional DCVax-L production capacity will be needed," commented Linda F. Powers, NW Bio CEO. "Today's funding will enable us to move forward on the development of this capacity for an increasing number of patients, including early access patients outside of our clinical trials involving some initial early revenues."

  • Reply to

    Breaking just out !!!!!!!!!!!!!!!!!!!!!!!

    by dinepat203 Apr 15, 2014 2:05 PM
    dinepat203 dinepat203 Apr 15, 2014 2:10 PM Flag

    NW BIO CLOSES ON FIRST $15 MILLION OF FINANCING FOR SUBSTANTIAL EXPANSION OF EUROPEAN PRODUCTION CAPACITY

    Major Production Increase Being Undertaken To Meet Growing Demand

    PR Newswire

    BETHESDA, Md., April 15, 2014



    BETHESDA, Md., April 15, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced the closing of the first $15 million funding by a single institutional investor of the registered direct placement of up to $32 million which was announced by the Company last week. These first 2.27 million shares of common stock were sold for $6.60 per share

  • Reply to

    Breaking just out !!!!!!!!!!!!!!!!!!!!!!!

    by dinepat203 Apr 15, 2014 2:05 PM
    dinepat203 dinepat203 Apr 15, 2014 2:06 PM Flag

    I told you something is up

  • NW BIO CLOSES ON FIRST $15 MILLION OF FINANCING FOR SUBSTANTIAL EXPANSION OF EUROPEAN PRODUCTION CAPACITY

    Tue Apr 15, 2014 1:11pm EDT

    *

  • Reply to

    $10 in less than 2 Hrs ...Bet you

    by dinepat203 Apr 15, 2014 11:03 AM
    dinepat203 dinepat203 Apr 15, 2014 1:37 PM Flag

    OLD NEWS BUT INTERIM RESULTS ARE AROUND CORNER

AFFY
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