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Home  /   Forum   /   BioPharma   /   RNAI - Sirna Therapeutics - Deel 2

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RNAI - Sirna Therapeutics - Deel 2

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87 Posts
Pagina: «« 1 2 3 4 5 »» | Laatste | Omlaag ↓
  5. [verwijderd] 30 augustus 2006 14:35
    quote:

    1gustaaf schreef:

    $ 6 kan makkelijk. Ze zijn zonder bijzondere reden teruggezakt van $ 8,50.
    G
    Ik denk dat het zelfs zo weer richting de 7 kan, als er maar goed nieuws is en het beurs sentiment niet weer de verkeerde kant op gaat. Er staat gewoon heel veel short, en het bedrijf heeft steeds minder risico.
  10. nbvdb 31 augustus 2006 18:36
    Leuk te zien dat jullie RNAI ook nog niet vergeten zijn. Het is natuurlijk altijd leuker om iets te posten als het wat beter gaat natuurlijk...

    Maar goed, ik ben er nog steeds van overtuigd dat dit aandeel heel heel veel potentieel heeft. Voor mij zijn de grote contracten met big-pharma het beste bewijs dat het echt wat is.

    Zoals Anna al zei, ongelooflijk dat dit aandeel nog steeds (of weer) zo laag staat. Maar goed, dat komt allemaal vanzelf goed. Geduld is een schone zaak.

    Mijn persoonlijke doel voor dit jaar is nog steeds $8, Voor eind volgend jaar iets van $15. We zullen zien
  12. [verwijderd] 11 september 2006 13:55
    Zeer matige resultaten van de concurrent:

    Acuity Pharmaceuticals Reports Positive Phase II Results for Bevasiranib in Wet AMD

    Monday September 11, 5:30 am ET

    -First Clinical Proof-of-Concept for siRNA Drug in Double Masked Patient Trial-

    -Biological Effect Seen at All Dose Levels with Encouraging Durability of Response in Population with Early Aggressive Disease-

    -Very Good Safety Profile with No Systemic Adverse Effects-

    -Results Support Advancing to Phase III with Potential for Use in Combination with VEGF Antagonists as Maintenance Therapy Following Acute Therapy Treatment-

    PHILADELPHIA and CANNES, France, Sept. 11 /PRNewswire/ -- Acuity Pharmaceuticals, a clinical stage ophthalmic pharmaceutical company, today announced positive results from its Phase II C.A.R.E(TM) trial for bevasiranib sodium (formerly Cand5), Acuity's lead compound for the treatment of wet age-related macular degeneration (wet AMD). Bevasiranib is a first-in-class small interfering RNA (siRNA) therapeutic designed to silence the genes that produce vascular endothelial growth factor (VEGF), believed to be largely responsible for this leading cause of adult blindness. The findings were presented yesterday at the 24th Annual Meeting of the American Society of Retina Specialists in Cannes, France.

    The Acuity Cand5 Anti-VEGF RNAi Evaluation, or C.A.R.E. study, was a randomized, double-masked trial that included three dose levels of bevasiranib tested in 129 patients with wet AMD at 28 sites nationwide. The study focused on patients with serious disease, classic or active minimally classic AMD, including those patients who had failed previous treatments.

    The drug was shown to be very safe in the study, with all doses well tolerated and most adverse events mild and related to the administration procedure. There were no systemic adverse events observed -- in two separate bevasiranib clinical trials, pharmacokinetic studies have now confirmed that there was no systemic bevasiranib exposure in patients, an important consideration in an agent targeting VEGF. The importance of this finding is highlighted by U.S. Food and Drug Administration language required in the labels of newly approved VEGF antagonist drugs warning of the possible risks of systemic exposure to VEGF inhibitors. It notes, "there is a theoretical risk of arterial thromboembolic events following intravitreal use of inhibitors of VEGF." The safety results and pharmacokinetic studies reported in this new study and in the Phase I data reported earlier provide strong evidence that bevasiranib does not enter the circulation, avoiding the potential for these serious systemic adverse events.

    "Bevasiranib is a promising new agent that has now demonstrated encouraging potential in this first large-scale study in wet AMD patients with aggressive disease," said Lawrence Singerman M.D., founder and executive secretary of the Macula Society, clinical professor of ophthalmology at Case University and a principle investigator for the study at its Cleveland site. "Bevasiranib's excellent safety profile, its demonstrated ability to inhibit the growth of choroidal neovascular lesions and its potential for prolonged duration of effect warrant proceeding to Phase III trials. Bevasiranib's potential to complement VEGF antagonist drugs in combination or as a maintenance therapy could provide an important benefit to patients, and I look forward to helping to assess its utility in future trials."

    Unlike VEGF antagonists, which neutralize VEGF that has already been produced in the eye, bevasiranib works by shutting down the genes that produce future VEGF. As a result, there is residual VEGF remaining in the eye during the first weeks of administration of bevasiranib, which stops production of new VEGF but does not neutralize the residual VEGF that naturally dissipates over time. Accordingly, the impact of the drug's anti-VEGF activity becomes evident only after several weeks of therapy, after the existing VEGF dissipates. This results in a lag between starting bevasiranib therapy and observing a therapeutic effect.

    This expected lag was seen in the C.A.R.E. study, where the results of bevasiranib's activity were most clearly demonstrated after several weeks of treatment. At that point, independently assessed flouroscein angiography scans confirmed that bevasiranib produced dose-dependent decreases in the growth and the size of the CNV lesions that are the primary characteristic of the disease. This key finding is an important confirmation that bevasiranib is working as expected to combat the primary anatomic feature causing vision loss in wet AMD.

    The duration of activity is a critical measure for wet AMD therapies, since these agents are administered by intravitreal injection, which can be burdensome if too frequent injections are required. Bevasiranib showed encouraging signs that it has a good duration of effect, evidenced by the fact that at the two higher doses CNV growth was on average essentially halted for at least 12 weeks following the last administration of bevasiranib.

    The "time to rescue" measure also demonstrated the durability of response. The study investigators had the option to "rescue" any patients with progressing disease using a then-FDA approved wet AMD therapy. According to the study protocol, patients received bevasiranib injections at baseline and week six and then were scheduled to be followed for two years with no additional study therapy. The median time to rescue in the lowest dose group was established at 154 days, or about 14 weeks after the last injection of bevasiranib. For the two higher dose groups no median time to rescue had yet been established, as a result of the fact that most of these patients, who had been in the study for up to six months following their last bevasiranib injection, did not yet require drug rescue as determined by their physicians.

    Despite the absence of a placebo arm in this trial, researchers were able to compare measures of visual acuity in study patients with what would have been expected from the natural course of disease progression as determined by reference to the most comparable placebo cohorts in other trials. In this analysis, bevasiranib study patients demonstrated stronger measures of visual acuity than predicted by the comparative placebo analysis. Visual acuity declined somewhat in the first months of the study, most likely from the on- going activity of the residual VEGF in the eye. On average, it then stabilized, with some visual acuity improvement in more than one-third of the patients, especially among those in the higher dose cohorts. Although no dose response was observed in measures of visual acuity in the bevasiranib study, there was a dose response trend observed in the important anatomic measure of CNV growth [LOL].

    "As pioneers in the clinical development of siRNA therapeutics, we are delighted with the encouraging results from this first large scale trial of bevasiranib in wet AMD," said Dale Pfost, Ph.D., president and CEO of Acuity. "The data provides us with confidence to proceed into Phase III pivotal trials, a clear path to eventual product approval and strong evidence that bevasiranib has the fundamental attributes needed for competitive positioning in the large and growing ophthalmic marketplace. We believe that bevasiranib has the potential to play an important role in the treatment of wet AMD as a resul
  20. [verwijderd] 28 september 2006 15:36
    Goed sector nieuws:

    Alnylam Awarded $23 Million U.S. Government Contract to Develop RNAi Therapeutics for Biological Threats

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 28, 2006--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), has awarded the company a contract to advance the development of a broad spectrum RNAi anti-viral therapeutic against hemorrhagic fever virus, including the Ebola virus. The federal contract (No. HHSN266200600012C) will provide Alnylam with $23 million in funding over a four-year period to develop small interfering RNAs (siRNAs), the molecules that mediate RNAi, as anti-viral drugs targeting the Ebola virus. The Ebola virus can cause a severe, often fatal infection, and poses a potential biological safety risk and bioterrorism threat.

    With this new contract, the company is establishing Alnylam Biodefense


    TM, an initiative to build a robust platform for developing RNAi therapeutics targeting threats of bioterrorism. Funding for this program, as with Alnylams pandemic flu program, represents an example of broad public health and federal interest in the potential of RNAi technology to treat and prevent disease from these, and other serious and life-threatening viruses. U.S. Government funding for development of RNAi therapeutics for Ebola virus extends Alnylams anti-viral pipeline, including programs for treatment of respiratory syncytial virus with ALN-RSV01, currently in Phase I clinical trials; pandemic influenza with ALN-FLU01 in a partnership with Novartis; and, JC virus in a recently announced partnership with Biogen Idec.

    We are pleased to receive this contract to develop an anti-viral RNAi therapeutic for Ebola, enabling us to launch efforts on our Alnylam Biodefense platform. We view this project as an important opportunity to strengthen our nations capabilities to counter serious biological security threats, said Barry Greene, Chief Operating Officer of Alnylam. In terms of our overall business strategy, funding for Alnylam Biodefense efforts will strengthen our platform capabilities and its applications for discovery of RNAi therapeutics for traditional clinical indications. Moreover, we believe that successful advancement of our Alnylam Biodefense efforts could create the potential for nearer-term product opportunities as a result of possible accelerated paths to approval and revenues from government stockpiling contracts.

    As part of a public sector-private sector partnership with its Ebola program, Alnylam is working with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), an organization which is uniquely experienced in the handling, safety, and security requirements of specialized biological agents. Alnylam will be producing drug candidates which will be sent to USAMRIID for in vitro and in vivo testing against the Ebola virus.

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