Key Developments: Active Biotech AB (ACTI.ST)

ACTI.ST on Stockholm Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Active Biotech AB Presents Follow-Up Data from Prostate Cancer Project with Tasquinimod Performed in Collaboration with EXINI Diagnostics AB (publ)
Monday, 3 Jun 2013 09:00am EDT 

Active Biotech AB announced that the Company has presented Phase II retrospective follow-up data from the prostate cancer project with tasquinimod at the scientific conference 2013 ASCO Annual Meeting held in Chicago (the United States). This study was performed in collaboration with EXINI Diagnostics AB (publ). The results show that Bone Scan Index (BSI) can be a more objective radiologic assessment in trials of men with metastatic castration-resistant prostate cancer, and is clearly associated with prognosis and disease burden. Tasquinimod had a favorable impact on the BSI over time, confirming the Company's original findings in the randomized phase 2 trial. The ability to obtain objective measures of bone metastases can help fuel drug development in this disease, where current bone scan assessments are often misclassified and very subjective.  Full Article

Active Biotech AB Announces Results of ANYARA Project and Seeks Partner for Continued Development
Monday, 3 Jun 2013 09:00am EDT 

Active Biotech AB announced that data from the ANYARA Phase II/III study in renal cell cancer showed that although the ANYARA Phase II/III study did not achieve its primary endpoint to show a prolonged OS in the overall ITT population, the addition of ANYARA to interferon-alpha improves OS and PFS in a biomarker defined subgroup. In this subgroup, patients with high levels of pre-formed antibodies against superantigens or the cytokine IL-6 were excluded. High baseline levels of these antibodies were shown to decrease ANYARA levels while the biomarker IL-6 has previously been suggested to be a predictive marker for immune therapies. Based on this results, the Company is seeking a partner for the continued development of this targeted cancer therapy.  Full Article

Active Biotech AB and Ipsen Update Analysis Plan for 10TASQ10 Trial Evaluating Tasquinimod in Treatment of Prostate Cancer
Thursday, 25 Apr 2013 01:00am EDT 

Active Biotech AB announced that the Company and Ipsen announced that the companies have updated the analysis plan for the 10TASQ10 trial, a global Phase III clinical trial evaluating tasquinimod in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not received chemotherapy. The companies plan to conduct the primary PFS analysis for the 10TASQ10 trial in 2014, at the same time as the first interim overall survival (OS) analysis. The time point for the OS interim analysis will be driven by the number of OS events. The specified number of radiographic progression-free survival (PFS) events for the primary end-point will have been exceeded at the time of interim OS analysis. The randomized, double-blind, placebo-controlled, Phase III 10TASQ10 trial met its enrollment target in December 2012 with 1,245 randomized patients as planned in the clinical protocol. The aim of the study is to confirm tasquinimod's efficacy, with radiological Progression Free Survival (PFS) as primary endpoint and overall survival (OS) as key secondary endpoint. The study recruited patients in 37 countries covering over 200 centers.  Full Article

Active Biotech AB Proposes No Dividend Payment for FY 2012
Thursday, 11 Apr 2013 02:30am EDT 

Active Biotech AB announced that its Board has decided to propose that no dividend should be paid for the fiscal year 2012.  Full Article

Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Results of Study on Laquinimod
Thursday, 21 Mar 2013 08:00am EDT 

Active Biotech AB announced that Teva Pharmaceutical Industries Ltd and Active Biotech announced on March 21, 2013 top-line results from the open-label extension of the Phase III ALLEGRO study that assessed progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start). Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS. Of 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. During the entire study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs. 16.7%, HR = 0.62, p < 0.0038). The study also supports a favorable safety and tolerability profile of laquinimod in RRMS patients. No new safety concerns arose during the open-label phase. Additionally, a preclinical study in animal models demonstrated the ability of laquinimod to increase the myelinated axons and mature oligodendrocytes in the brain. This data suggests laquinimod has potential restorative and anti-inflammatory properties.  Full Article

Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Enrollment of First Patient in Third Phase II Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis
Wednesday, 6 Mar 2013 08:00am EST 

Active Biotech AB announced with Teva Pharmaceutical Industries Ltd the enrollment of the first patient in the CONCERTO study - the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). The multinational, randomized, double blind placebo-controlled study will aim to enroll approximately 1,800 patients at over 300 sites. Along with the primary endpoint of time to confirmed disability progression, the study will also examine the impact of laquinimod on endpoints such as percentage change in brain volume and other clinical and MRI markers of disease activity.  Full Article

Active Biotech AB Raises SEK 270 Million Through Directed New Issue to Investor AB
Wednesday, 6 Mar 2013 02:30am EST 

Active Biotech AB announced that its Board of Directors has resolved to issue in total 6,000,000 new shares in the Company to Investor AB (publ). The shares are issued at a subscription price of SEK 45 per share, providing the Company with in total approximately SEK 270 million after transaction costs. The closing price for the Active Biotech share on NASDAQ OMX Stockholm on March 5, 2013 was SEK 48.80. The issue proceeds are intended to be used to strengthen Active Biotech's capital base and to enable the continued development and value-growth of the project portfolio. The new issue also strengthens Active Biotech's position in discussions with potential partners. The Board considers it being beneficial for the Company and the shareholders to broaden the shareholder base and to take advantage of the opportunity to raise capital on favorable terms for the Company from a well renowned investor. Active Biotech's two main shareholders MGA Holding AB and Nordstjernan AB, and East Bay AB, with a joint holding of votes and shares of approximately 44%, have stated that they support the new issue. Through the new issue, the number of shares in Active Biotech will increase by 6,000,000 from 68,923,582 to 74,923,582 and the share capital will increase by SEK 22,616,055.93 from SEK 259,796,597.53 to SEK 282,412,653.46. Investor's holding will correspond to approximately 8% of the shares and votes in Active Biotech.  Full Article

Active Biotech AB Announces Results from Phase II/III ANYARA Trial For Treatment Of Renal Cell Cancer
Monday, 28 Jan 2013 02:39am EST 

Active Biotech AB announced initial results from the ANYARA Phase II/III clinical study. The study encompassed 513 patients and was designed to evaluate effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was overall survival (OS). The results showed that ANYARA Phase II/III study did not achieve primary endpoint to show a prolonged OS in ITT population. Unexpectedly, and in contrast to previous studies in other territories, a majority of patients in the current study had high levels of pre-formed antibodies against superantigen component of ANYARA. A subgroup analysis, excluding patients with high levels of pre-formed antibodies, resulted in a trend for survival benefit with ANYARA treatment. Furthermore, baseline levels of the biomarker IL-6 was shown to be an important predictive marker for a positive treatment effect of ANYARA. In a hypothesis generating subgroup analysis, 25% of patients with low/normal levels of base line IL-6 and expected anti-superantigen antibody levels, showed a statisticall treatment advantage on both OS (p=0.02, HR=0.59) and PFS. In North America and Western Europe, this subgroup account for 40-50% of the total number of advanced renal cell cancer patients. The safety profile was good and in line with previous observations; the common adverse events associated with ANYARA treatment were grade 1-2 fever, nausea or vomiting.  Full Article

Active Biotech AB And Ipsen SA Announce Completion of Recruitment of Tasquinimod Clinical Phase III Study in Prostate Cancer
Monday, 10 Dec 2012 01:30am EST 

Active Biotech AB And Ipsen SA announced that the Phase III clinical trial for tasquinimod, a compound for the treatment of prostate cancer, is successfully enrolled with over 1,200 randomized patients as planned in the clinical protocol.  Full Article

Ipsen SA and Active Biotech AB Initiate Phase II Switch Maintenance Trial in Metastatic Castrate-resistant Prostate Cancer with Tasquinimod
Wednesday, 3 Oct 2012 12:45pm EDT 

Ipsen SA and Active Biotech AB announced the initiation of a new phase II proof of concept clinical trial, evaluating the activity of tasquinimod in advanced metastatic castrate resistant prostate cancer patients. The study aims at establishing the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy. The "switch maintenance" trial is part of the initial agreement with Active Biotech to enhance tasquinimod's data package beyond the ongoing phase III placebo-controlled study in men with bone-metastatic CRPC, which has been adequately powered to detect an OS improvement.  Full Article

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