Daily Blog - Tiger Software

                            September 8, 2007

           Biotech Series:  Stocks Fighting Prostate Cancer

   GTXI: Tiger Biotech Profits Are As Easy As "1-2-3".

     William Schmidt,     - Tiger Software's Creator
      (C) 2007 William Schmidt, Ph. D.  - All Rights Reserved. 

      No reproductions of this blog or quoting from it
      without explicit written consent by its author is permitted.

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GTX Inc.   3 Ndunlap Street   3rd Floor Van Vleet Building   Memphis, TN 38163   United States - Map   Phone: 901-523-9700   Web Site: http://www.gtxinc.com GTx, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of small molecules to treat cancer, osteoporosis and bone loss, muscle wasting, and other serious medical conditions in the United States.  Research

                  1)   The company markets FARESTON tablets for the treatment of metastatic breast
     cancer in postmenopausal women through wholesale  drug distributors.  This has relatively
    slim annual sales of $3 million

                  2)    Its primary drug candidate in clinical development is ACAPODENE, a selective
      estrogen receptor modulator, which is in pivotal Phase III clinical trials for the treatment
      of multiple serious side effects of androgen deprivation therapy, for advanced prostate
      cancer; and for the prevention of prostate cancer in high risk men with precancerous
      prostate lesions called high grade prostatic intraepithelial neoplasia (PIN).  "Each of these
      indications is $500 million-plus [in annual drug sales] if the data is compelling,"
      said Eric Schmidt, analyst for SG Cowen & Co. "If they were able to achieve that
      type of revenue -- $500 million -- this stock would be a home run."

                  3)  GTXI has initiated the Phase IIb clinical trial evaluating Ostarineâ„¢,
     a selective androgen receptor modulator, or SARM, for the treatment of
     cancer cachexia, muscle wasting.  Cachexia is a debilitating, progressive muscle
     wasting condition manifested by unintentional weight loss, muscle weakness, anemia,
     fatigue, and death. More than 50% of cancer patients present with or subsequently
   develop cachexia.  There are no drugs approved by the FDA for the treatment of
     cancer cachexia.

                                                                  Background

             Currently, an important, but problematic, treatment for prostate cancer is hormonal
       therapy (ADT) that reduces testosterone production.  GTx's new drug ACAPODENE is in the
       pivotal Phase III trrals.  Its purpose is to treat the serious, even deadly side effects of ADT
       therapy, as patients live longer. 

             In June 2006,   the company announced that patients taking ACAPODENE enjoyed
       a reduction in chlorestol, but is primarily aiming for a reduction in vertebral fractures as
       well as improvements in bone marrow density, osteoporosis and  muscle wasting.  Final
       data on this trial is expected in the second half of 2007.  The December 2005 interim report
       showed ACAPODENE did significantly increase Bone Mineral Density (BMD) compared to
       placebo.
       ( http://72.14.253.104/search?q=cache:fgya1O-D3O8J:www.medicalnewstoday.com/articles/45760.php+ACAPODENE&hl=en&ct=clnk&cd=3&gl=us&client=firefox-a )
            
                      Note that the drug's successful completion of Phase III trials, does not offer definite
       assurance of FDA approval and a successful drug launch.  The cost of the drug was
       one critical concern.  Another was whether enough safety data will be offered the FDA. 
       In that connection, it was auspicious that France's Ipsen has agreed on September
       6, 2005 to pay $30 million to license GTX's Acapodene for European distribution.
       (  www.fiercebiotech.com  ) On July 12, 2007 the  company reported an independent safety
       review of the drug administered in triail to 3,000 patients passed muster.

        A second and separate Phase III clinical trail continues to evaluate ACAPODENE for
        the "prevention of prostate cancer in men with high grade prostatic intraepithelial
        neoplasia (PIN). Nearly 1,600 patients with high grade PIN have been enrolled in the trial. 
        GTx anticipates that sufficient cancer events will have occurred to conduct this interim
        efficacy analysis by the first quarter of 2008. If the interim efficacy analysis reveals that
        ACAPODENE  20 mg treatment reduces prostate cancer and achieves the pre-specified
        level of statistical significance, GTx plans to submit a New Drug Application....

                                                                           Ownership

         The biggest institutional shareholder is FMR CORPORATION (FIDELITY MANAGEMENT
         & RESEARCH CORP) with 5.228.561 shares (15% of outstanding stock) valued at $84.65
         million.  Fidelity's Biotech Fund does not list this in its top ten holdings, but has 253,273
         shares. ..  By far, the biggest individual owner is Joseph R Hyde III with 6.240.028 shares. 
         He is on the Board of Directors of GTx, Inc and FDX    The company's two co-founders,
         Dr. Mitchell S Steiner (46) and Marc S Hanover (46) have 26,500 and 105,138 shares.

                                                       Techniques for Trading GTXI

              Tiger Software offers pioneering research into how to trade successfully stocks like
       GTXI.  Consider how use the relative strength indicator defined as "RSQ", the quotient of
       GTXI divided by BBH (Biotech Index).  First, look at the GTXI chart for 2006.  The Tiger
       RSQ broke out significantly ahead of price.  The stock was only 10.81.  The earlier
       Tiger "Buy B16" signal confirmed the relative strength breakout.  The clustered major
       Tiger Buys that soon followed showed a very nice move was taking place.

                                                                            GTXI - 2006


            
                                                                    GTXI - 2007

               With the stock having nearly doubled in four months, we should be ready to
         take profits.  See below how Tiger's RSQ Indicator broke its uptrendlne ahead of
         the stock's breaking of its 50-day moving average.  Many traders use the popular
         50-day moving average to identify intermediate-term trend changes.   

              The RSQ (GTXI/BBH) for GTXI is now going sidewise.  We would be watching
       for a breakout to signify that a powerful new uptrend has started given the stock's
       fundamental outlook.                                               



                                                              GTXI - 2006

                    Traders should also have noted the very high readings in October from the
           Tiger's Accumulation Index.  In these circumstances, such readings were reason enough
           to buy the stock in anticipation of a price breakout to a new high over 12.5.  Afterwards,
           the actual achievement of the new high in November 2006 was another signal to buy
           the stock. GTXI here was an an attractive way to invest in the biotech field in the then
           rising general stock market.  The first dip in January stopped just above its rising
           50-day moving average.  The resumption of the rally from this point was very constructive.

                                                          GTXI - 2007

                           In April 2007 the stock turned down and on high (red) volume closed decisively
                below its (blue) 50-day moving average.  With the stock having doubled in five months,
                profits might reasonably have been taken when its 50-day moving average was broken. 
                Even better, was taking the Tiger "S27" as a major Sell a month earlier.

                          The chart now shows an emerging 10 month-wide head and shoulders top.
                The neckline-support is at 14.  The right and left shoulders both have apexes at 19.  
                That level constitutes resistance.  The fact that the stock's 50-day moving average
                 is declining should keep us away from the stock, though it is a positve that the
                Accumulation Index is quite positive.
        

        
    

                                                                            end of report
    
        

                                           The next Blog will take up:

Dendreon's prostate cancer drug Provenge is in high demand and has proven to extend life for several months. Instead of buying the common I suggest taking a look at the January 2008 $7.50 calls for $1.60.

.

             Drugs at the Clinical Stage -- In the Pipeline

                                                .http://www.pipelinedrugs.com/

The Biotech-100 Index includes 100 small cap biotechnology stocks whose product drug pipeline contain at least one drug in either phase II and/or Phase III clinical development. There is a 90% chance of rejection in early-stage phase I clinical trials; a 50% chance in phase II; 20% in phase III; and 10% post-phase III. Companies that are in phase II and III tend to show great promise but still have a high degree of volatiliy.

      
   Useful Links:



http://www.biotech-weblog.com/50226711/snake_venom_toxin_inhibits_human_prostate_cancer_cell_growth.php

http://www.prostate-cancer.org/resource/links.html     

FDA advisers back Dendreon's prostate-cancer drug
     http://seattletimes.nwsource.com/html/businesstechnology/2003642497_provenge30.html

prevously Provenge delay triggers furor among cancer victims

Sanofi-Aventis and Regeneron say that they have launched two Phase III trials for aflibercept--or
VEGF Trap--with chemotherapy for lung and prostate cancer.
      http://www.fiercebiotech.com/tags/prostate-cancer

       Novacea cheered on decision to expand cancer trial

An FDA expert committee has dealt a blow to GPC Biotech, concluding
unanimously that regulators should wait for survival data before approving
its prostate cancer drug Orplatna (satraplatin). The Read more...  7/25/2007
      http://www.fiercebiotech.com/story/gpc-cancer-drug-voted-down-fda-committee/2007-07-25

      Press Release: Genaera Corporation Discontinues LOMUCIN in Cystic Fibrosis
      and Squalamine in Prostate Cancer Studies  7/5/2007