ISIS Pharma
mittelgroßes pharma-unternehmen aus den staaten. bei den analysten offenbar sehr beliebt. hat schon ein medikament rausgebracht und einige in der pipeline (gut diversifiziert).
ist in den letzten 2-3 wochen billig geworden. überlege mir eine einstieg...
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auf der anderen seite steht die aktie fast überall auf buy oder strong buy und bei boerse-go.de steht aktuell z.b.:
ISIS Pharmaceuticals wird - glaubt man dem Gerücht - in Kürze positive Testergebnisse für das Medikament gegen Lungenkrebs ISIS 3521 präsentieren. Am 21. Mai soll das Unternehmen das Produkt während der ASCO Konferenz präsentieren.
...könnt doch was sein!?
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Mit viel Zeit ein super Invest, da die meisten garnicht wissen was Antisense ist und was für Chance für völlig neuartige Medikamente sich dadurch eröffnen.
Leo35: Halte ich für sehr interessant, da hier eine vollkommen neue Technologie zum Einsatz
kommt und damit auch neue Indikationen und bisjetzt nicht heilbare Krankheiten in den Fokus rücken, was natürlich später auch mal zu weniger Konkurrenz führen könnte...Zudem bestätigen die vielen Partnerschaften auch das Interesse anderer Biotechs an dieser Technologie...ich kopiere hier nur mal eine wichtige Nachricht vom Januar 2008 rein:
"Zudem erinnere man sich nun vor allem der im Januar in trockene Tücher gebrachten Kooperation mit Genzyme, die es vor dem Hintergrund der jüngsten News in sich haben könnte. Bei dem Projekt gehe es um einen neuen Cholesterinsenker, der nach dem Debakel von Vytorin/Zetia auf einen weitaus weniger umkämpften Markt stoße als bisher erwartet. Der Wert addiere sich laut Vertrag auf Meilensteinzahlungen von bis zu 1,5 Mrd. USD zuzüglich 50% Gewinnbeteiligung einer möglichen Produkteinführung" (22.04.2008 Global Biotech Investing).
Hier werden die nächste Generation Wirkstoffe entwickelt, das was nach den Antikörpern kommt...und ISIS verfügt zudem über ein sehr gutes IP Portfolio und verdient schon gut an Lizenzen. - Zumindest beobachten finde ich -
Genzyme and Isis Begin New Clinical Trials of Mipomersen
CAMBRIDGE, Mass. & CARLSBAD, Calif., Jan 12, 2009 (BUSINESS WIRE) --
Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced that they have begun two new studies of mipomersen, a novel lipid-lowering drug in late-stage development, and a third is currently screening patients. These three trials will provide additional data on mipomersen in high-risk patient populations. The new studies, together with ongoing trials, will also substantially increase the size of the database of patients treated with mipomersen over the next 18 months.
The trial currently screening patients will evaluate the safety and efficacy of mipomersen in patients with severe hypercholesterolemia who are on a maximally tolerated lipid-lowering regimen (previously referred to as apheresis-eligible patients). This phase 3 study includes patients who are not on LDL cholesterol apheresis but who have such severely elevated LDL-C levels that they are eligible for the procedure, and will enroll up to 75 patients.
In addition, the companies recently initiated a phase 3 trial in hypercholesterolemic patients on maximally tolerated dosages of statins who are at high risk for coronary heart disease. This study will enroll up to 180 patients. The companies have also begun a new phase 2 study in high-risk, high-cholesterol patients who are intolerant to statins, which will enroll up to 30 patients.
All three new trials are double-blind, placebo-controlled studies in which patients will be randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks, with percent change in LDL-C as the primary endpoint.
The companies in August began a phase 3 trial of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH), a genetic disorder that causes severely elevated LDL-C levels.
Genzyme and Isis Announce that Mipomersen Phase 3 Study in Patients with Homozygous Familial Hypercholesterolemia Met Primary Endpoint
25 Percent LDL-C Reduction in Very High-Risk Patient Population
CAMBRIDGE, Mass. & CARLSBAD, Calif., May 20, 2009 (BUSINESS WIRE) -- Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25 percent reduction in LDL cholesterol after 26 weeks of treatment, vs. 3 percent for placebo (p<0.001). This study also met each of its three secondary endpoints of reduction in apolipoprotein B, total cholesterol and non-HDL cholesterol (all p<0.001).
Although the patients were on maximally tolerated statins and other lipid-lowering therapies, their average LDL-C at baseline was greater than 400 mg/dL. The reductions observed in the study were in addition to those achieved with the patients' existing therapeutic regimen. Full data from the study will be presented at a future medical meeting.
"These are promising results for a very high-risk patient population that is in great need of new treatment options," said Genzyme Chief Medical Officer Richard A. Moscicki, M.D. "This is one of the largest studies of hoFH patients ever conducted, and we are very encouraged by these robust data and the emerging profile of the drug. With these results, we remain on-track with our development plan for mipomersen."
Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases. Of the 34 patients treated with mipomersen, 28 completed the study. One patient discontinued due to elevations in liver transaminases.
"The results announced today are good news for patients with hoFH," said John J. P. Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the Department of Vascular Medicine at the Academic Medical Centre Amsterdam. "The currently available treatments do not provide the magnitude of lipid lowering that these patients need, leaving them at extraordinarily high risk of cardiovascular events. Mipomersen has the potential to change the standard of care for hoFH patients, whose life expectancies are limited due to the severity of this disease."
"This is a historic moment for Isis and antisense technology as this study represents the first successful phase 3 trial with a systemically delivered antisense drug," said Isis Pharmaceuticals Chairman and CEO Stanley T. Crooke, M.D., Ph.D. "This drug exemplifies the potential of the antisense drug discovery platform pioneered by Isis. We look forward to benefitting patients in need with mipomersen and other drugs in our pipeline."
Ziel erfüllt, Kurs runter?? Oder hatte man mal wieder höhere Erwartungen...
The trial was a randomized, double-blind, placebo-controlled study that enrolled 51 hoFH patients, aged 12 and older. Seven patients were aged 12 to 17. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo via weekly injections for 26 weeks. The trial was conducted at 10 sites in seven countries in North America, Europe, Asia, South America and Africa.
Data from this phase 3 study of mipomersen in patients with hoFH will form the basis of Genzyme's initial regulatory filing for marketing approval, which is anticipated in the second half of 2010.
und wenn das erste Medikament dann erst mal auf dem Markt ist, wird der Kurs weiter steigen...und die Pipeline ist voll.
Analog zu Morphosys wird es hier ab 2015 sehr interessant - ich hoffe mal, die werden dann nicht aufgekauft, sondern wir sehen erst mal 100 Euro / Aktie..:-)
und die erste Zulassung kommt auch bald.:-) darüberhinaus hat ISIS eine interessante klinische Pipeline, die in den nächsten 1-2 Jahren noch einiges abwerfen sollte.
Isis Pharma ist meines Erachtens eine echt interssante Biotechfirma:
- steht kurz vor der Zulassung des ersten Porouktes in den USA und Europa
- hat 340 Mio USD Cash
- viele Partnerschaften und daher auch eine volle Pipeline
- zudem kommt man an ISIS nicht vorbei, wenn man mi siRNA arbeiten will, 1500 Patente zeigen ihre Wirkung.:.-)
CARLSBAD, Calif., Aug. 6, 2012 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (ISIS) today reported pro forma net operating income of $6.2 million for the three months ended June 30, 2012 and a pro forma net operating loss (NOL) of $10.0 million for the six months ended June 30, 2012 compared to a pro forma NOL of $11.6 million and $24.9 million for the same periods in 2011. The significant improvement in the Company's operating results was driven primarily by the $25 million milestone payment Isis earned from Genzyme when the FDA accepted the new drug application (NDA) for KYNAMRO™ in the second quarter. The Company ended the second quarter of 2012 with $336 million in cash.
"The planned European and United States launches of KYNAMRO™ will be important milestones for Isis and for antisense technology. KYNAMRO™ commercialization will change our financial position by adding commercial revenue to the steady stream of income we receive from our partnerships," said B. Lynne Parshall, Chief Operating Officer and CFO of Isis. "We have maintained a strong financial position as we have approached this important event while also advancing the rest of our pipeline. We have utilized an innovative and unique business model that has provided us with the cash to expand and mature our industry-leading pipeline. As we look toward the future, in addition to KYNAMRO™ commercial revenue, we have other significant near-term opportunities for continued revenue growth with a wave of potential product launches in the next three to five years. We also look forward to completing clinical studies on several drugs that could be very attractive licensing candidates."
Upcoming Key Milestones
- Present KYNAMRO™ data at the upcoming European Society of Cardiology highlighting the potential of KYNAMRO™ to reduce the need for lipid-apheresis by lowering LDL-C values below thresholds for apheresis eligibility
- Report clinical data from multiple drugs in Isis' pipeline, including ISIS-SMNRx, an antisense drug Isis is evaluating in patients with spinal muscular atrophy
- Initiate a clinical study of ISIS-TTRRx in patients with familial amyloid polyneuropathy
- Earn a $25 million milestone payment from Genzyme following FDA marketing approval for KYNAMRO™
- Anticipate marketing approval of KYNAMRO™ in the United States and Europe
Financial Results
On a GAAP basis, Isis reported income from operations of $3.7 million for the three months ended June 30, 2012 and a loss from operations of $14.8 million for the six months ended June 30, 2012 compared to a loss from operations of $14.1 million and $30.2 million for the same periods in 2011.
All pro forma amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.
Revenue
Revenue for the three and six months ended June 30, 2012 was $47.3 million and $70.6 million, respectively, compared to $24.8 million and $46.0 million for the same periods in 2011. Isis' revenue fluctuates based on the nature and timing of payments under agreements with the Company's partners, including license fees, milestone-related payments and other payments. For example, Isis' revenue in the first half of 2012 was significantly higher than in the first half of 2011 primarily as a result of the $25 million milestone payment from Genzyme for FDA acceptance of the KYNAMRO™ NDA. Also in the first half of 2012, Isis sold $6.2 million of drug substance to Genzyme to support the planned commercial launch of KYNAMRO™ and began recognizing revenue from the $29 million upfront payment the Company received from Biogen Idec earlier this year. These increases were partially offset when the amortization of the upfront payments associated with the Genzyme collaboration ended in May 2012.
In June 2012, Isis and Biogen Idec entered into a new collaboration and license agreement for the development of a drug to treat myotonic dystrophy (DM1). As part of this collaboration, Isis received a $12 million upfront payment, which Isis will begin amortizing into revenue over five years starting in the third quarter of 2012.
Operating Expenses
On a pro forma basis, operating expenses for the three and six months ended June 30, 2012 were $41.2 million and $80.6 million, respectively, compared to $36.4 million and $70.9 million for the same periods in 2011. The moderately higher expenses in the first half of 2012 were primarily due to higher development costs associated with Isis' maturing pipeline of drugs offset by lower development expenses related to KYNAMRO™ because Genzyme is now sharing these expenses equally with Isis until KYNAMRO™ is profitable. Genzyme is paying all of the marketing and selling expenses until KYNAMRO™ is profitable.
On a GAAP basis, Isis' operating expenses for the three and six months ended June 30, 2012 were $43.6 million and $85.3 million, respectively, compared to $38.9 million and $76.1 million for the same periods in 2011.
Net Loss
Isis reported a net loss of $1.2 million and $25.2 million for the three and six months ended June 30, 2012, respectively, compared to $17.9 million and $37.9 million for the same periods in 2011. Basic and diluted net loss per share for the three and six months ended June 30, 2012 was $0.01 per share and $0.25 per share, compared to $0.18 per share and $0.38 per share for the same periods in 2011. Isis' net loss for the first half of 2012 decreased compared to the same period in 2011 primarily due to a decrease in Isis' net operating loss offset, in part, by additional non-cash interest expense the Company recorded for the long-term liability associated with its new facility.
Balance Sheet
As of June 30, 2012, Isis had cash, cash equivalents and short-term investments of $336.0 million compared to $343.7 million at December 31, 2011 and had working capital of $295.4 million at June 30, 2012 compared to $284.0 million at December 31, 2011. The decrease in cash in the first half of 2012 primarily relates to cash used to fund Isis' operations offset by the $25 million milestone payment Isis received from Genzyme and the $29 million upfront payment Isis received from Biogen Idec. Isis' cash balance at June 30, 2012 does not include the $12 million upfront payment that the Company received in July 2012 from its new collaboration with Biogen Idec to develop and commercialize a drug to treat DM1. Including the $12 million from Biogen Idec, Isis has received more than $875 million from its corporate partnerships since 2007.
Business Highlights
"It has been a very productive first half of 2012 for Isis. We have had many important achievements already this year, including the acceptance of the KYNAMRO™ NDA by the FDA. The KYNAMRO™ NDA filing brings us one step closer to commercializing this important new drug for patients who are at great risk of dying from their cardiovascular disease. KYNAMRO™ represents the first major commercial opportunity for Isis, and we are looking forward to its planned launch in Europe and in the United States," continued Ms. Parshall.
"We have been very successful with our partnerships, bringing in more than $85 million in cash so far this year. The most significant payment was the $25 million milestone payment we received from Genzyme for acceptance of the NDA filing. We also established a new alliance with Biogen Idec valued at up to $271 million, including the $12 million upfront fee we recently received," continued Ms. Parshall. "Our new alliance with Biogen Idec allows us to expand our severe and rare disease franchise to include DM1, a devastating neuromuscular disease. This is the second alliance we have established this year with Biogen Idec, and we benefit tremendously from Biogen Idec's expertise in developing and commercializing drugs to treat neurodegenerative diseases. This expertise complements our ability to discover and develop new antisense drugs to many diseases, including neurodegenerative diseases for which there are limited treatment options and potentially rapid routes to the market."
"We expect an eventful second half of 2012 as we continue to make significant progress in advancing our pipeline. We anticipate reporting clinical data from a number of drugs in our pipeline, advancing several drugs into later-stage clinical studies and continuing to add new drugs to our pipeline. Of course, KYNAMRO™ will remain center stage. We look forward to sharing news about KYNAMRO™ and the rest of our pipeline as the year progresses," concluded Ms. Parshall.
Corporate and Drug Development Highlights
- KYNAMRO™ continues to advance in development and move closer to the market for patients with severe forms of familial hypercholesterolemia (FH; homozygous FH and severe heterozygous FH), at high cardiovascular risk, who cannot reduce their LDL-C sufficiently with currently available lipid-lowering therapies.
- The FDA accepted for filing the NDA for KYNAMRO™ for the treatment of patients with homozygous FH.
- Isis received a $25 million milestone payment from Genzyme for the KYNAMRO™ NDA filing.
- A clinical investigator presented an analysis of Lp(a) data from the KYNAMRO™ Phase 3 program at the European Atherosclerosis Society. The data demonstrated sustained reductions of Lp(a), an independent risk factor for cardiovascular disease.
- Isis received European GMP certification of its manufacturing facility for production of drug substance to support KYNAMRO™ commercial launch.
- Isis initiated a Phase 2 study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia, a condition characterized by high levels of triglycerides that is often associated with premature coronary artery disease and pancreatitis.
- Isis formed a new strategic alliance with Biogen Idec to develop and commercialize a drug to treat DM1 that expands Isis' severe and rare disease franchise. Isis received a $12 million upfront payment and is eligible to receive up to an additional $259 million in a licensing fee and milestone payments. Isis will also receive double-digit royalties on product sales.
- Isis and collaborators published a paper in Nature demonstrating that an antisense compound selectively and rapidly reduced target RNA in skeletal muscle and alleviated disease in animal models of DM1.
- Isis and collaborators published a paper in Neuron demonstrating that an antisense compound reversed disease in animal models of Huntington's disease.
- Isis received Orphan Drug Designation in the U.S. for ISIS-TTRRx for the treatment of TTR amyloidosis.
Isis tumbles after FDA panel raises concerns over drug
Isis Pharmaceuticals (ISIS) is slumping after documents produced by an FDA panel recommended that the agency only allow certified doctors to prescribe the company's mipomersen, also known as Kynamro. The documents recommended the restriction because it found that the drug - a treatment for the disorder HoFH which causes very high cholesterol - could allegedly cause liver damage. Only HoFH patients should receive the drug, while other people with high levels of cholesterol in their blood shouldn't be treated with mipomersen, the briefing documents stated. Moreover, the drug had caused several types of tumors in some animals "at clinically relevant exposures," according to the documents. In a note to investors earlier today, research firm Piper Jaffray wrote that the information about tumors is a negative surprise that will reduce the likelihood that an FDA panel will recommend approval of the drug when it meets on Thursday. The firm downgraded the stock to Neutral from Overweight and lowered its target on the shares to $10 from $18. Meanwhile, shares of Aegerion (AEGR), which has also developed a treatment for HoFH, are rising for the second day in a row. FDA documents for Aegerion's drug, Lomitapide, released yesterday said that the drug increases liver fat, but that the process appears to be reversible. Furthermore, the documents reported that an increased amount of liver tumors appeared in mice only after being treated with the drug for two years. A small, statistically significant increase in intestinal tumors occurred in mice that received 25 times the amount of the drug that humans would be given. In late morning trading, Isis slumped $1.96, or 14.91%, to $11.19.
Heute, 21.2.14 ist der Kurs 43,054€ in Frankfurt. Meine Bemerkungen wurden von dem
schönen heutigen Kurssprung veranlasst, vielleicht schafft die Aktie noch die 60$. Das sind sehr gute 55% innerhalb von 5 Monaten. Da kann ich nur sagen, Ruhe bewahren, denn der
Trend ist mein friend.
Eine Perle :-)
Nur meine Meinung
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Es wurde eine Erhöhung er Leberwerte beobachtet, aber dies war nicht mit erhöhten Bilirubinwerten oder anderen Markern einer Leberschädigung assoziiert. Es wurde keine Erhöhung des LDL, des Blutdruckes oder des Körpergewichtes beobachtet.
Hintergrund: ISIS-GCGRRx wurde in der ersten Woche an drei verschiedenen Tagen mit unterschiedlichen Dosierungen gegeben und danach 1xwöchentlich. ISIS-GCGRRX ist das am höchsten entwickelte Medikament der Pipeline, zu dem auch noch ein antisense-GLUKOKORTIKOID-Rezeptor, eine antisense-PTP-1B-Rezeptor und ISIS-PTP1BRx (in der Phase 2) gehören.
den Blutzuckerspiegel. Bindet Glukagon an seine Rezeptoren in der Leber, wird gespeicherte Glukose ins Blut abgegeben. Erhöhte Glukagonspiegel und die signifikante postprandiale Hyperglukagonämie tragen sowohl bei Typ-1- als auch bei Typ-2-Diabetes
zur Hyperglykämie bei, so Prof. Finbarr P. O’Harte von der University of
Ulster in Nordirland. Glukagon rezeptor antagonisten hätten damit das Potenzial,
Hyperglykämien zu bekämpfen. In einem Tiermodell für Typ-1-Dia -
betes konnten zwei neue Glukagon -rezeptorantagonisten Glukosetoleranz
und Insulinsensitivität verbessern und Hyperglykämien unterbinden. O’Harte
informierte, dass es sich in beiden Fällen um Peptide handelt, wobei eines der
beiden auch betazellprotektive Effektein der Bauchspeicheldrüse aufwies.
Möglicherweise könnte in einigen Jahren auch Oxyntomodulin, ein Peptidhormon
aus dem Dünndarm, bei Typ-2-Diabetikern zum Einsatz kommen. Vielversprechende
Ergebnisse mit dieser Substanz präsentierte Dr. Sudha S. Shankar
von den Merck Research Laboratories New Jersey. In einer kleinen randomisierten
und doppelblinden Studietestete sie bei zwölf Typ-2-Diabetikern,
denen Glukose infundiert wurde, wie sich die Betazellfunktion änderte, wenn
sie zusätzlich Oxyntomodulin, Liraglutid oder Plazebo erhielten. Es zeigte
sich, dass die blutzuckersenkenden Effekte von Oxyntomodulin und Liraglu -
tid vergleichbar waren. Laut Shankar hängt dieser direkte blutzucker regu lie -
rende Effekt von Oxyntomodulin wahrscheinlich auch mit einer GLP-1-Rezeptor-
Aktivierung zusammen.
Eine neue Substanz macht Hoffnung in der Prävention postoperativer venöser Thromboembolien: Die Arznei konnte in der Phase-II-Studie mehr Thrombosen verhindern als vergleichbare gängige Wirkstoffe, ohne dass das Blutungsrisiko stieg.
FXI-ASO verhindert die Entstehung von VTE, indem es den Faktor-XI-Spiegel senkt.
AMSTERDAM. Mit dem AntisenseOligonukleotid FXI-ASO wurde ein neues Konzept zur Verhinderung venöser Thromboembolien erstmals am Menschen untersucht: Das Senken des Gerinnungsfaktor-XI-Spiegels.
Durch den selektiven Ansatz — FXI-ASO unterbindet gezielt die Produktion von Faktor-XI-Messenger-RNA in der Leber — erhofft man sich einen antithrombotischen Effekt ohne großen Einfluss auf die Hämostase.
Die Forscher um Harry R. Büller von der Uni Amsterdam setzten die neue Substanz bei 300 Patienten ein, die sich einer elektiven Kniegelenkersatz-Op unterzogen.
In der Phase-II-Studie ging es zum einen um Wirksamkeit und Sicherheit, zum anderen um den Vergleich mit dem etablierten Gerinnungshemmer Enoxaparin (NEJM 2014; online 7. Dezember).
FXI-ASO ist NMH nicht unterlegen
FXI-ASO wurde subkutan, entweder in einer Dosis von 200 oder 300 mg gespritzt, beginnend 36 Tage vor dem Eingriff. Im Vorfeld der Op erfolgten die Injektionen dreimal wöchentlich in der ersten Woche und einmal wöchentlich in den folgenden vier Wochen.
Nach der Op wurde noch zweimal gespritzt, nämlich sechs Stunden postoperativ und noch einmal drei Tage später.
Enoxaparin wurde in einer Dosis von 40 mg einmal am Vorabend oder bis zu acht Stunden nach Op sowie danach über mindestens eine Woche täglich appliziert.
Acht bis zwölf Tage nach dem Eingriff führten die Forscher bei allen Patienten eine Venografie durch.
Zu venösen Thromboembolien (VTE) war es in den zwölf Tagen bei 30 Prozent der Patienten unter dem niedermolekularen Heparin (NMH) und bei 27 Prozent der 200-mg-FXI-ASO-Gruppe gekommen.
Unter der höheren Dosierung FXI-ASO hatten sich VTE in 4 Prozent ereignet. Damit hat die neue Substanz den Autoren zufolge die Kriterien für "Nicht-Unterlegenheit" erfüllt. Die 300-mg-Dosis war dem NMH in puncto Wirksamkeit signifikant überlegen.
Keiner der Patienten hatte in der dreimonatigen Nachbeobachtungszeit eine Lungenembolie entwickelt, Todesfälle wurden nicht berichtet.
Klinisch relevante Blutungen, die zumindest eine Vorstellung beim Arzt erforderten, hatten sich in den insgesamt vier Monaten nach Therapiebeginn in den beiden FXI-ASO-Gruppen zu jeweils drei Prozent ereignet, mit Enoxaparin zu acht Prozent.
Bei 38 bzw. 29 Prozent der FXI-ASO-Gruppen hatten die Patienten eine Bluttransfusion benötigt; unter Enoxaparin-Gruppe war das bei 32 Prozent der Fall. Diese Unterschiede waren nicht signifikant.
"Das Potenzial von FXI-ASO besteht darin", so die Forscher, "dass es postoperative Thrombosen effektiver vermeidet als konventionelle Antikoagulanzien." Der Pluspunkt: Die Blutungsgefahr sei dabei nicht erhöht.
Wie die Forscher betonen, wirkte sich die neue Substanz ausschließlich auf die endogenen Faktoren der Blutgerinnung aus: Lediglich die partielle Thromboplastinzeit (PTT) wurde verlängert, nicht dagegen die Thromboplastinzeit (TPZ).
Innerhalb des intrinsischen Pfades war die Wirkung hochspezifisch: Während die Spiegel des Gerinnungsfaktors XI dosisabhängig gesenkt werden konnten, blieben die anderen Komponenten dieser Kaskade, die Faktoren VIII, IX und XII, offenbar unbeeinflusst.
Blutungsrisiko wirklich geringer?
Durchschnittlich sank der Faktor-XI-Spiegel in der 300-mg-Gruppe zum Zeitpunkt der Op auf 0,2 U/ml. Die mittlere PTT stieg dabei auf 1,4. Dennoch blieben die postoperativen Hämoglobinwerte ähnlich wie unter Enoxaparin.
Für die Studienautoren ist dies ein zusätzlicher Hinweis auf die Sicherheit des neuen Konzepts.
Ob man mit einem Konzept, das gezielt am Faktor XI angreift, wirklich die Hämostase ausspart, ob sich also Thrombosen wirklich verhindern lassen, ohne die Blutungsgefahr zu erhöhen, muss erst noch bewiesen werden, schreibt Studienkommentator Robert Flaumenhaft von der Harvard Medical School in Boston im New England Journal of Medicine.
Der Unterschied zwischen den Blutungsraten sei schließlich nicht signifikant gewesen; zudem seien schwere Blutungen nach einem Eingriff wie dem Kniegelenkersatz relativ selten, selbst unter Antikoagulanzien.
Letztlich muss sich die Idee der FXI-ASO-Investigatoren also noch in größeren Studien bewähren.
ISIS reports 36-week phase 2 data for its once-weekly PTP-1B inhibitor antisense, ISIS-PTP1BRx, showing a reduction in HbA1c of 0.7% vs 0.2% in the placebo group, based on a trial (n=92) in subjects with T2DM on metformin ± SU (baseline HbA1c 8.6%; BMI 34 kg/m2).
Significant body weight reductions were reported in the ISIS-PTP1BRx group (no numbers provided).
The most common adverse event was infrequent injection site reactions. No clinically significant abnormalities or cases of severe hypoglycaemia were reported. (ISIS press release 3 February 2015)
Comment: ISIS-PTP1BRx acts as an insulin sensitizer by targeting protein-tyrosine phosphatase 1B. The primary endpoint of the ISIS-PTP1BRx phase 2 trial was HbA1c reduction after 26 weeks; these data have not been disclosed.
The company, however, states that improvements in glucose control continued to increase throughout the treatment period, indicating a lower efficacy at the primary endpoint. In 2014, ISIS reported phase 2 data for its glucagon receptor antisense, ISIS-GCGRRx, showing improvements in HbA1c of up to 2%. Phase 2 data for the company's glucocorticoid receptor antisense, ISIS-GCCRRx, are expected in 2015.
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Isis Reports Financial Results And Highlights For Second Quarter 2015
- Substantial Net Income Driven by More Than $180 Million in Revenue
- 2015 Financial Guidance Significantly Improved
- Conference Call Webcast Tuesday, August 4, 11:30 a.m. ET at www.isispharm.com
CARLSBAD, Calif., Aug. 4, 2015 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today reported net income of $35.6 million and $18.9 million for the three and six months ended June 30, 2015, respectively, compared to a net loss of $12.1 million and $43.4 million for the same periods in 2014. Isis' significantly improved financial results were driven primarily by the more than $90 million of revenue Isis earned in the second quarter related to the upfront payment from Bayer to license ISIS-FXIRx. Isis increased its cash position during the first half of 2015, ending June with more than $750 million in cash compared to approximately $730 million at December 31, 2014. The increase in the Company's cash position was primarily due to the more than $165 million in cash received from its partners in the first half of 2015.
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oder wieso schmiert der Kurs momentan so ab? Oder liegt es eher daran, dass es keine Neuigkeiten gibt? Zugegeben, die Biotechs laufen diese Woche nicht so übermäßig.
Leider findet man nich allzu viele aktuelle Informationen im Netz über das Unternehmen.
Wie sind so eure Meinungen? Position aufstocken? Zu den Analysten Einschätzungen gibt es ja jetzt wieder großes Upside-Potenzial.
Ärgerlich nur, dass ich bei rd. 57 € rein bin...