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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 ↓
  1. Koos Burema 10 juli 2006 13:35
    Om ervoor te zorgen dat threads overzichtelijk en duidelijk blijven, zetten we voortaan threads met meer dan 1.000 berichten voort in een nieuwe thread: deel 2.

    De laatste pagina van deel 1 van 'Ook SIRNA' kunt u vinden op:

    www.iex.nl/forum/topic.asp?forum=215&...

    --- Koersen ---

    www.iex.nl/stocks/stocks_detail.asp?I...

    quotes.nasdaq.com/asp/summaryquote.as...

    Met vriendelijke groet,

    Koos Burema
    forum@iex.nl
  2. [verwijderd] 18 juli 2006 19:22
    Koers in no-time weer teruggezet van $ 6 naar een day-low van $ 4,10. Het hele sentiment is al niet best, en die van de biotechnologie in het bijzonder.
    Het wordt tijd dat we weer eens getrakteerd worden op een opbeurend bericht omtrent de pipeline en/of aankondiging nieuwe partner(s).
    Het is de laatste tijd wel erg stil aan de overkant...
    Zijn alle Sirna-aanhangers nog steeds aandeelhouder, of hebben jullie alle aandelen eruit gegooid?
  6. [verwijderd] 10 augustus 2006 14:31
    DJ Sirna Therapeutics Reports Final Results From Phase 1 Study On Its RNAi-Based Therapeutic For Age-Related Macular Degeneration>RNAI

    08/10/2006
    Dow Jones News Services
    (Copyright © 2006 Dow Jones & Company, Inc.)


    (MORE TO FOLLOW) Dow Jones Newswires

    08-10-06 0819ET

    Copyright (c) 2006 Dow Jones & Company, Inc.

    *DJ Sirna: 100% Visual Acuity Stabilization Observed >RNAI


    (MORE TO FOLLOW) Dow Jones Newswires

    08-10-06 0820ET

    Copyright (c) 2006 Dow Jones & Company, Inc.

    *DJ Sirna: Single Ascending Doses Of Sirna-027 Safe, Well Tolerated

  7. [verwijderd] 10 augustus 2006 14:44
    Sirna Therapeutics Reports Final Results from Phase 1 Study on Its RNAi-Based Therapeutic for Age-Related Macular Degeneration
    Thursday August 10, 8:19 am ET

    100% Visual Acuity Stabilization observed in All Patient Groups Eight Weeks after a Single Dose of Sirna-027

    SAN FRANCISCO, Aug. 10 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (Nasdaq: RNAI - News), a leading RNAi-based therapeutics company, reported the final results from its recently completed Phase 1 trial for Sirna-027, a novel therapeutic for age-related macular degeneration (AMD). Single ascending doses of Sirna-027 were safe and well tolerated, and all 26 patients (100%) showed visual acuity stabilization eight weeks after a single injection. In addition, at the same time point, five of 26 patients (19%) experienced clinically significant improvement in visual acuity, indicated by an increase of at least three lines on an eye chart.
    ADVERTISEMENT



    Three months after a single injection, 24 of 26 patients (92%) showed visual acuity stabilization, with four of 26 patients (15%) experiencing clinically significant improvement in visual acuity; only two of 26 patients (8%) experienced a reduction in visual acuity of three lines or more. Importantly, a decrease in foveal thickness was observed in some patient groups, which is an indication of biological activity of Sirna-027.

    "This is the first demonstration of biological activity of a chemically optimized siRNA in humans," said Sirna Chief Medical Officer Roberto Guerciolini, M.D. "These data represent an important milestone toward the demonstration of the potential therapeutic benefit of Sirna-027 and the clinical validation of RNAi as a therapeutic modality."

    The potential for a long-lasting effect on visual acuity after a single dose of Sirna-027 could be due to the unique catalytic mechanism of short interfering RNA (siRNA), and could make this compound amenable to a more favorable dosing regimen than other approved products.

    "Less frequent dosing in this devastating disease should greatly improve patient convenience, compliance, and quality of life," said Dr. Guerciolini.

    The Phase 1 study evaluated the safety, tolerability, and biological effect of single-ascending doses of Sirna-027 in patients with AMD. A total of 26 patients with active disease were enrolled to receive a single intravitreal injection of Sirna-027 ranging from 100-1,600 micrograms.

    In September 2005, Sirna and Allergan, Inc., a global leader in eye care, established a Strategic Alliance in eye diseases which includes Sirna-027 for AMD. Under the terms of the Agreement, Allergan assumed all developmental and commercialization costs for Sirna-027. Sirna and Allergan expect to initiate the Phase 2 trial during the second half of 2006.
  12. [verwijderd] 14 augustus 2006 16:51
    NEW YORK, August 14 (newratings.com) - Analyst Jonathan Aschoff of Brean Murray reiterates his "strong buy" rating on Sirna Therapeutics Inc (ticker: RNAI). The target price is set to $11.

    In a research note published on July 11, the analyst mentions that the final Phase 1 AMD results for Sirna-027 validate the efficacy of the drug in treating AMD over the long-term. The Phase II testing of Sirna-027 is expected to commence in 2H06 and Sirna Therapeutics’ partner, Allergan, is to bear the development and commercialization expenses of the drug going forward, the analyst says.
  13. [verwijderd] 14 augustus 2006 22:44
    Sirna Therapeutics Reports Second Quarter 2006 Financial Results
    Monday August 14, 4:04 pm ET

    SAN FRANCISCO, Aug. 14 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (Nasdaq: RNAI - News) reported financial results today for the quarter ended June 30, 2006.
    ADVERTISEMENT


    Sirna reported a net loss of $10.1 million, or $0.15 per share in the second quarter of 2006, compared to a net loss of $6.0 million, or $0.14 per share, for the same period in 2005. Revenues for the second quarter of 2006 were $0.9 million compared to $1.5 million for the same quarter in 2005. Deferred revenues from collaboration partners, included on our balance sheet at June 30, 2006, were $10.9 million.

    Operating expenses were $11.7 million for the three months ended June 30, 2006 compared to $7.6 million for the same period in 2005. Operating expenses for the second quarter of 2006 included $0.9 million of share-based employee compensation expense related to Sirna's adoption of Statement of Financial Accounting Standards No. 123R as of January 1, 2006. Excluding the share-based employee compensation expense, non-GAAP operating expenses for the second quarter of 2006 were $10.8 million and the non-GAAP net loss was $9.2 million or $0.14 per share.

    R&D expenses, excluding 123R effects, were $6.9 million for the quarter ended June 30, 2006 compared to $4.8 million in the second quarter of 2005. Our increase in R&D expenses reflects the advancement of the Company's pipeline programs toward the clinic, the manufacturing of Sirna-034 in preparation for Phase I clinical trials in hepatitis C and the relocation of core scientific teams to our new research center in San Francisco.

    G&A expenses, excluding 123R effects, were $3.9 million for the quarter, compared to $1.6 million in the second quarter of 2005. This increase in expenses is primarily due to the additional business development and alliance management activities necessary to establish and grow key corporate partnerships, expansion of our intellectual property estate, employee relocation expense, and Sarbanes-Oxley compliance.

    The Company ended the second quarter with $92.2 million in cash, cash equivalents and securities available for sale, which includes $47.4 million in net proceeds from the Company's follow-on offering completed in May 2006 and $12.0 million in cash proceeds from our partner GlaxoSmithKline as a result of the alliance entered into in March 2006. With these additional financial resources, the company is expanding its drug development activities and forecasts 2006 operating use of cash in the range of $30-$33 million.

    "With over $92 million in financial resources at the end of the quarter, no debt, and the potential for additional collaboration revenues, we believe that we are in an excellent financial position to execute on our strategy," said Howard W. Robin, Sirna President and CEO. "In just a short period of time, we have established valuable strategic collaborations with Allergan and GlaxoSmithKline, and we are confident that we will have continued success in our strategy of establishing increasingly valuable collaborations with companies that are leaders in their fields."

    Recent Highlights

    * The Company completed a secondary offering of 10.4 million shares at $5
    per share, and received total net proceeds of approximately $47.4
    million. In addition, the Company received $12.0 million in up-front
    payments from GlaxoSmithKline as part of its collaboration in
    respiratory disease.

    * Sirna reported the final two month and three month results from its
    recently completed Phase 1 trial on Sirna-027, our RNAi-based drug for
    AMD which is partnered with Allergan, Inc. Single ascending doses of
    Sirna-027 were safe and well tolerated, and all 26 patients (100%)
    showed visual acuity stabilization eight weeks after a single
    injection. In addition, at the same time point, five of 26 patients
    (19%) experienced clinically significant improvement in visual acuity,
    indicated by an improvement of at least three lines on an eye chart.
    Twelve weeks after a single injection, 24 of 26 patients (92%) showed
    visual acuity stabilization, with four of 26 patients (15%)
    experiencing clinically significant improvement in visual acuity.
    Together with Allergan, we expect to initiate a Phase 2 study in the
    second half of 2006.

    * Sirna is completing the enabling toxicology studies on Sirna-034, our
    RNAi-based drug for hepatitis C, and plans to file an IND with the FDA
    in the second half of this year. The Company has started the
    manufacturing of Sirna-034 for the Phase 1 clinical trial.

    * As part of our exclusive, multi-year collaboration with GlaxoSmithKline
    (GSK) in respiratory diseases, the companies initiated preclinical
    programs to develop RNAi-based drugs for asthma and respiratory
    syncytial virus.

    * Three key events occurred in the second quarter that solidify Sirna's
    intellectual property position in the field of RNAi-based medicines and
    drug delivery technologies:

    * In April, the U.S. Patent and Trademark Office issued Sirna a
    patent covering any chemically modified siRNA targeting I Kappa
    B kinase-gamma (IKK-gamma). This is the first siRNA target
    patent issued in the United States and sets an important
    precedent for Sirna's entire target patent portfolio.
    Importantly, the claims of the patent cover any siRNA sequence
    used against the gene and cover any type of chemical
    modification or structure.

    * Sirna acquired the exclusive worldwide license to the Zamore,
    et. al. microRNA patents from the University of Massachusetts
    Medical School and the non-exclusive worldwide license to the
    Tuschl, et. al. microRNA patents from New York's Rockefeller
    University. Both licenses cover microRNA technology (commonly
    known as antagomirs) crucial to the modulation of gene
    expression. The combination of these licenses, together with
    Sirna's existing microRNA patent portfolio, gives Sirna a
    leading IP position in microRNAs.

    * Sirna's successful opposition led to the European Patent Office
    (EPO) significantly limiting the scope of the claims of the
    Kreutzer-Limmer patent, which is held by a third-party patent
    holder. The claims have now been limited to methods of making
    and using double stranded RNA with structures that we believe
    are not commercially relevant to the discovery and development
    of RNAi-based medicines.

    * Shares of Sirna Therapeutics were added to the Russell 3000 Index and
    Russell 2000 Index, effective June 30, 2006.

    Conference Call Information
    Sirna Therapeutics President and CEO Howard W. Robin and his senior management team will discuss progress to date in their clinical and preclinical programs and provide an overview of financial results during a conference call on Monday, August 14th at 4:30 p.m. EDT (1:30 p.m. PDT). A live audio webcast of the call will be available at the Company's co
  14. [verwijderd] 15 augustus 2006 10:43
    Allemaal weer zeer goed nieuws, iets hogere kosten maar dat was wel te verwachten. Bijna niet te geloven dat dit bedrijf zo laag staat.

    Net de webcast ook even geluisterd. Nog leuk nieuws de komende maanden: nieuwe patentent, zeker nog een nieuwe partner, ind voor hepatitis-c, start fase 2 amd, en nog inkomsten van allergan en voor de ontwikkeling voor glaxo.
  15. [verwijderd] 15 augustus 2006 11:10
    quote:

    -Anna- schreef:

    Allemaal weer zeer goed nieuws, iets hogere kosten maar dat was wel te verwachten. Bijna niet te geloven dat dit bedrijf zo laag staat.

    Net de webcast ook even geluisterd. Nog leuk nieuws de komende maanden: nieuwe patentent, zeker nog een nieuwe partner, ind voor hepatitis-c, start fase 2 amd, en nog inkomsten van allergan en voor de ontwikkeling voor glaxo.
    Anna kijk eens naar de omzetverwachting in 2007 die is niet echt groot. Dus het duurd heel lang voor ze winst gaan maken, en jij hebt steeds commentaar op INSM. Laat me niet lachen, INSM heeft volgend jaar al een omzet van rond de 60.000.000.
  16. [verwijderd] 15 augustus 2006 11:35
    quote:

    M.A.D.W. schreef:

    Anna kijk eens naar de omzetverwachting in 2007 die is niet echt groot. Dus het duurd heel lang voor ze winst gaan maken, en jij hebt steeds commentaar op INSM. Laat me niet lachen, INSM heeft volgend jaar al een omzet van rond de 60.000.000.
    enig idee hoeveel ze aan milestones binnen gaan krijgen en hoe groot de markten zijn waar ze voor ontwikkelen in samenwerking met allergan en gsk? Ook al maakt dit bedrijf nog 3 jaar geen winst dan nog is het niet raar als ze straks meer dan 2 miljard waard zijn met al hun technologie, medicijnen, licenties en patenten.
  17. [verwijderd] 15 augustus 2006 11:41
    quote:

    -Anna- schreef:

    [quote=M.A.D.W.]

    Anna kijk eens naar de omzetverwachting in 2007 die is niet echt groot. Dus het duurd heel lang voor ze winst gaan maken, en jij hebt steeds commentaar op INSM. Laat me niet lachen, INSM heeft volgend jaar al een omzet van rond de 60.000.000.
    [/quote]

    enig idee hoeveel ze aan milestones binnen gaan krijgen en hoe groot de markten zijn waar ze voor ontwikkelen in samenwerking met allergan en gsk? Ook al maakt dit bedrijf nog 3 jaar geen winst dan nog is het niet raar als ze straks meer dan 2 miljard waard zijn met al hun technologie, medicijnen, licenties en patenten.
    Ik ben het met je eens dat het een bedrijf met een goede vooruitzicht. Maar de opbrengsten zijn voorlopig niet erg groot. Dus het is wel een bedrijf voor de lange termijn. Dus een prima investering in de LT-portefeuille.
  18. [verwijderd] 15 augustus 2006 11:47
    quote:

    M.A.D.W. schreef:

    Ik ben het met je eens dat het een bedrijf met een goede vooruitzicht. Maar de opbrengsten zijn voorlopig niet erg groot. Dus het is wel een bedrijf voor de lange termijn. Dus een prima investering in de LT-portefeuille.
    Op nieuws komend jaar kunnen ze zo weer hard omhoog zeker omdat er iets van 6 miljoen short staan. Maar zeker een middel lang tot lange termijn belegging. Op korte termijn te onvoorspelbaar. Volgend jaar met resultaten van hcv kan het wel hard gaan.
  19. [verwijderd] 15 augustus 2006 22:02
    Motley Fool
    Sirna Battles Genes Gone Bad
    Tuesday August 15, 12:30 pm ET
    By Ralph Casale

    Sirna Therapeutics (Nasdaq: RNAI - News) is one of several companies hoping to shut down diseases and disorders at the genetic level. Viruses and cells gone bad spread their malicious genetic instructions through messenger RNA (mRNA). But small bits of double-stranded RNA, known as small interfering RNA, or siRNA -- hence Sirna's name -- can "knock down" that translation, destroying the offending mRNA. In essence, siRNA can switch off unhealthy or damaging genes.
    ADVERTISEMENT


    Sirna hopes to create drugs based on this process of RNA interference (RNAi). Though it's still a young technology, RNAi was dubbed 2002's breakthrough of the year by Science magazine, and it's already considered indispensable in many drug-discovery programs for the validation of promising drug targets.

    So far, Sirna has advanced just one drug into clinical trials. Sirna-027 is directed at age-related macular degeneration (AMD), a leading cause of blindness among the elderly. It recently completed a successful phase 1 trial, and it's expected to progress to phase 2 later this year. Allergan (NYSE: AGN - News), a strategic partner in the development of this treatment, will run the phase 2 trial. Competitor Alnylam Pharmaceuticals (Nasdaq: ALNY), which is also seeking RNAi-based treatments, recently halted a similar program directed at this indication.

    Sirna Therapeutics' preclinical pipeline is robust. Sirna-034, directed at hepatitis C, should enter the clinic after the completion of its investigational new drug filing, expected later this year. Sirna-034 is a combination of two small interfering RNAs and a nanoparticle delivery vehicle. It proved effective at decreasing viral counts in infected primate models. Treatment of hepatitis C would require systemic delivery of Sirna-034 to humans, a traditionally large hurdle for siRNA and related antisense-based drugs. In addition to Sirna-034, the company has pre-clinical programs directed at treatments for Huntington's disease, hair removal, and diabetes.

    The company also recently signed a collaboration agreement with GlaxoSmithKline (NYSE: GSK - News) to develop therapeutics for respiratory ailments. Partnerships with big pharma firms like GSK are often strong indications of a medical technology's potential. Rival Alnylam Pharmaceuticals can count Merck (NYSE: MRK - News) and Novartis (NYSE: NVS - News) as collaborators for RNAi-based drug development.

    Sirna Therapeutics currently has more than $92 million in cash, with no debt. Its war chest was boosted by a $47.4 million follow-on offering in May 2006. Given management's projected annual burn rate of $30 million-$33 million, that should give the company adequate funds to demonstrate the effectiveness of a few more of its therapies in clinical trials. Signing additional partnerships and collaborations should bolster Sirna's development program as well.

    While drugs based on RNA interference may have the potential to become the next big thing in biotechnology, they're still a long, long way from becoming FDA-approved, marketable entities. Still, Fools with an eye toward the future should keep tabs on RNAi research firms like Sirna, and the developments they discover.

    GlaxoSmithKline is a Motley Fool Income Investor selection; Merck was a former Income Investor pick.

    Fool contributor Ralph Casale is constantly trying to keep all his genes from getting knocked down. He owns shares in GlaxoSmithKline, but holds no financial position in any other firm mentioned. The Fool has a disclosure policy.

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