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The enormous advancement in the biological sciences that is taking place has begun to change the traditional way of practicing medicine. Far-reaching biological products are being approved and news about breakthroughs are occupying the headlines. However, selecting the biotechnology firms in... More
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  • CYTORI (CYTX): A STEM CELL HOPE FOR URINARY INCONTINENCE

    A study was led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine demonstrate that stem and regenerative cells from a patient’s own fat tissue used to treat stress urinary incontinence (SUI) demonstrate efficacy in severe cases. The cells in the study were processed using Cytori’s Celution® 800 System during the operative procedure.

    The results, reported at the 7th Annual Meeting of the International Federation for Adipose Therapeutics and Science, suggest that the treatment is safe and feasible.  The adipose-derived stem and regenerative cells (ADRCs) were delivered via two distinct formulations. First, they were injected directly into the bladder sphincter with the goal of improving muscle contraction. Secondly, ADRCs were combined with the patient’s own fat tissue to create a cell-enriched bulking agent to improve closure upon sphincter contraction. They were five patients whose stress urinary incontinence  resulted from radical prostatectomy.

    The follow-up examinations were thorough and frequent at two, four, eight, and 12 weeks. They were assessed for continence, intraurethral and leak point pressures (measures of urethral sphincter tone) and quality-of-life.  Imaging studies were made.     

    Dr. Yamamoto comments confirmed that the transplanted cells stimulate new blood supply in the treated area, stabilize the transplanted tissue over time, and increase the urethral pressure in the majority of patients treated. “These early findings give hope to millions of patients suffering from untreatable incontinence and the resulting impact on their quality of life. Based on these results, we look forward to expanding the study to a larger population of patients.”

    At twelve weeks following treatment, three of five patients showed improvement in leakage, urethral closure, and quality-of-life assessment. These three patients were diagnosed as having severe incontinence. Two of the five patients did not show improvement in these measures and were diagnosed as having very severe incontinence before treatment. It is likely that these very extreme cases, which represent the most difficult clinical challenge, could require multiple treatments.

    Is this not great news for the 16 million new patients each year who lose ability to control their urinary flow in the United States alone. Besides the men who had prostatectomy, stress incontinence is common in women, even more common than in men, as it results from childbirth, menopause and natural aging.  

    Indeed it is great news for the sufferers from urinary incontinence, the physicians who have yet to find a safe satisfactory answer and the millions of patients who suffer the painful embarrassing condition.

    Disclosure: No Positions


    Oct 21 10:08 AM | Link | 4 Comments
  • XOMA (XOMA): WHAT DO WE NEED FROM THIS FIRM?
    Xoma signed a collaboration agreement with Arana Therapeutics Limited, a wholly owned subsidiary of Cephalon (CEPH). The agreement involves multiple proprietary antibody research and development technologies, including a new antibody phage display library, and a suite of integrated information and data management systems. XOMA is getting a $6 million fee and will be entitled to milestone payments and royalties on product sales. XOMA will be fully reimbursed for all services it may provide to Arana under the agreement.

    Why Xoma?  

    Steffen Nock, Acting Chief Executive Officer of Arana said, “Xoma provides a complete suite of validated technologies that enable us to accelerate our antibody development programs toward the clinic. We believe the advantages of these technologies, including XOMA's next-generation antibody libraries, will increase our capacity to cost-effectively develop novel therapeutics."

    -------------------

    Prohost Biotech never doubted the high value of Xoma’s scientific and technological capability. We hailed the firm’s early involvement in the bacterial secretion of antibody domains and we were among the first to appreciate the value of its bactericidal cell expression (BCE) technology for the high-level expression it provides. Yes, we were aware all-along of the firm’s advantages. The problem, though, is that Xoma kept providing its treasures to others and barely used them for itself. which might have been caused us enormous losses. .   

    Our great awareness of Xoma’s excellent technologies and its capabilities of developing targeted therapeutics made us become high hopers, having great expectations for Xoma’s achievements.  Betting on this firm’s scientific and technological capability was correct and smart, except for ignoring that betting on whatever one loves about a firm would include an automatic betting on the firm’s management. This was our sin. The firm’s bright science blinded our eyes, preventing them from unveiling the past managements’ incompetence. For over a decade, Xoma’s superior scientific fundamentals and its built-in huge experience have failed to create value for the firm’s loyal shareholders. As a matter of fact, the firm’s value kept shrinking until it almost disappeared.  

    Xoma’s genius was wasted on efforts spent towards rescuing the firm from its managements’ bad decisions, improper choices and uncontrolled spending. Confident that the firm has all that is required for a biotech firm to generate billions of dollars in revenues, the firm’s loyal shareholders lost their investment before they saw any of Xoma’s proprietary products reach the market. Xoma must have fallen into coma during the past decade. At the end of a decade of struggling for survival, the firm had transformed into a poverty-stricken charitable organization. Drugs developed through Xoma’s technologies, Cimza and Lucentis, are generating billions of dollars in revenues for their owners, while Xoma is getting a few bucks that it calls royalties, which it immediately spends on nothing that is visible in its pipeline.   

    Our question is: Will the current management change the firm’s direction from extra-spending to what would turn some of its revenues into earning? Will it stop claiming that giving away its technological expertise for pennies is a victory? Will it co-develop its breakthrough proprietary therapeutics with other firms on 50-50 partnership bases? Is this not the only hope for generating billions of dollars in revenues?

    Xoma can still strike it big. It has more chances than ever for generating billions of dollars from its monoclonal antibody therapeutics. As a matter of fact a rare opportunity presents now in some of its drugs, precisely Xoma’s multi-targeted investigational therapeutic, XOMA 052. The drug is in two clinical studies for Type 2 diabetes. The molecules target key inflammatory pathways that contribute to the death and impairment of insulin-producing cells. There are no current marketed diabetes drugs aimed at protecting the insulin making cells. The same drug tackles also other inflammatory conditions, including rheumatoid arthritis, gout, systemic juvenile idiopathic arthritis, and cardiovascular disease. Further positive results from XOMA 052 would take the stock price to where it was a few years ago, i.e., over ten times its current stock price.

    XOMA 052 is a Human Engineered™ IgG2 antibody. The antibody has an ultra high binding affinity for IL-1β of 300 femtomolar. Based on its combined pharmacokinetic and binding properties, XOMA 052 may provide a convenient dosing of once per one month or longer. If successful and passes the clinical trial tests, XOMA 052 would become the first drug ever to treat diabetes and other inflammatory diseases with once a month injection. Studies with XOMA 052 for rheumatoid arthritis have already been initiated.
     
    Some studies have demonstrated that Amgen’s drug Kineret (Anakinra), an interleukin-1 (IL-1) receptor antagonist, has had positive results on Type 2 diabetes. These studies validate the results of XOMA 052. Anikanra is already marketed for other inflammatory diseases. The difference, however, is that Kineret is administered through daily injections while Xoma 0.52 could be administered once a month.

    That said, we will continue riding Xoma’s wave, but sitting on the driver’s seat. We cannot accept our investment to disappear, particularly not as a consequence of management’s inefficiency and lack of stamina. What we need now from the current management is accountability and transparency. We are determined to get both. Among other things, we need to know the fate of Xoma’s product HCD122, a monoclonal antibody that targets CD40, the same target of Rituxan, Genentech’s and Biogen Idec’s best selling lymphoma and anti-inflammatory disease drug. Xoma had licensed this important drug to Chiron, but the drug ended up in Novartis’ lap in April 2006 when this firm acquired Chiron. We want to learn about Novartis’ intended plans and the timetable it has put for various processes that would lead to the drug marketing, if any.

    We have not given up on Xoma, because we still believe in its great drug discovery, design and development capabilities. The time has come, though, for the large libraries of molecules to fill Xoma’s pipeline with second to none drugs, instead of filling our ears with bragging. We will not act like the mother who told her son that he is an excellent writer, which led her husband to remark, “Indeed he is, provided he starts to write.”

    We will make sure that with the technological wealth in its hand, Xoma’s management will indeed write a happy ending for the company’s tragic story.  

    Disclosure: No Positions
    Sep 21 8:33 AM | Link | 1 Comment
  • CYTRX (CYTR): NERVE REGENERATION TEN HOURS FOLLOWING A STROKE
     Nerve regeneration after a stroke was a wishful thinking by sufferers from stroke-induced paralysis.  The location of nerve damage depends on the site of the brain area where a clot occurs. The paralysis could be a paraplegia or a quadriplegia or local, but still detrimental such as the nerve damage that affects eye sight, speech and swallowing, which causes the victims to choke when drinking liquids, or solid food that could result in aspiration pneumonia or suffocation.  

         When tissue plasminogen activator (t-PA) was introduced by Genentech, emergency physi-cians and paramedics succeeded, for the first time, in aborting stroke and heart attack before they cause damage to the central nervous system and heart muscle consecutively. The success of t-PA, though, depends on administering it in within the first three hours following the stroke. Many stroke victims, however, still develop early or late nerve damages with debilitating results. That’s why re-enervation, or nerve regeneration remains a big dream and any news of any pro-gress in this respect is appreciated and considered a victory. 

         Today, we have news that promises improvement in protecting and regenerating neurons fol-lowing stroke. Results of a study conducted with Cytrx’ drug arimoclomol under the direction of world-renowned stroke expert Dr. Michael Chopp of the Department of Neurology in the Henry Ford Health System, and other institutions demonstrated that the drug exhibited statistically sig-nificant neuroprotective and neuroregenerative effects in brain cells of animals induced with stroke. Arimoclomol was effective when administered ten hours or more after the onset of stroke.    

         Stroke-induced rats received an oral dose of arimoclomol or a control substance daily for 28 days with the initial dose administered either 6, 10, 24 or 48 hours after stroke. Sections of brain tissue were then evaluated for each of the following: 1) chaperone protein HSP70; 2) the num-ber of cells with the characteristic DNA cleavage caused by apoptosis; 3) the microglial cell marker IB4-receptor; or 4) a marker for newly developing brain cells called double-cortin. 

         Detailed cellular analysis these rats brains showed a significant increase in HSP70 - molecu-lar chaperone expression. It showed a decrease in apoptosis and of microglial cells that cause inflammation. Most importantly, the drug resulted in an increase in the number of developing neurons sprouting new projections, called neurites, which are indicative of neuroregenera-tion. 

    HSP70 and doublecortin were detected with specific antibodies to the respective proteins, DNA cleavage was detected by a standard assay called TUNEL, and IB4-receptor was measured by binding to IB4-ligand.

         Despite the fact that Cytrx expected arimoclomol to increase HSP70 expression and therefore might prevent cells from undergoing apoptosis, it still was thrilled to discover that the drug has controlled the proliferation of inflammatory microglial cells and stimulated neuroregenera-tion as well. These latter effects may explain arimoclomol’s ability to restore brain function even when administered well after the stroke event, because the negative effects of inflammatory cells and the positive effects of neuroregeneration occur much later than the initial damage. 

        CytRx is expert in molecular chaperone regulation technology. The firm has two orally administered, clini-cal-stage drug candidates and has recently discovered a series of additional compounds that may provide additional drug candidates. Cytrx’ drug candidates are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of "molecular chaperones." Because damaged proteins are thought to play a role in many diseases, activation of molecular chaperones that help reduce the accumulation of misfolded proteins may have therapeutic efficacy in a broad range of disease states. Similarly, CytRx believes that the inhibition of molecular chaperones that normally help protect cancer cells from toxic misfolded proteins may result in the selective destruction of cancer cells.

    CytRx expects the new drug results and the information generated about its action to attract po-tential pharmaceutical or biotechnology partners for further development of arimoclomol. Attrac-tive also to wealthy firm might be the fact that arimoclomol’s clinical testing for stroke recovery could be relatively inexpensive, as more patients could be treated at fewer sites due to the ex-panded therapeutic window. 

    The CytRx pipeline comprise cancer programs, including tamibarotene in a registration study for acute promyelocytic leukemia (APL) and two other drug candidates based on its industry-leading molecular chaperone technology, which aims at repairing or degrading misfolded proteins associ-ated with disease. 

    CytRx maintains a 39% equity interest in publicly traded RXi Pharmaceuticals(OTC:RXII). 

    Disclosure: No Positions
    Aug 27 11:58 AM | Link | Comment!
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