Posted On: 02/03/2016 8:15:34 AM
Post# of 1460
More good for AVXL,
Fletch
Anavex Life Sciences Corp (NASDAQ:AVXL) Best Bet For Alzheimer’s
FEBRUARY 3, 2016 BY ALEX CARLSON LEAVE A COMMENT
The news that Pfizer Inc (NYSE
FE) has shuttered its Phase II Alzheimer’s drug study has sent shock waves through the biotech world. Shares of Axovant Sciences Ltd (NYSE:AXON) got hammered on the news. The Pfizer news has deep ramifications for Axovant’s Alzheimer’s drug which has the same mechanism of action as Pfizer’s. While this has left investors in Axovant with many questions, the one answer we came up with is that Anavax Life Sciences Corp (NASDAQ:AVXL) looks like a better bet for the treatment of Alzheimer’s with ANAVEX 2-73 than ever before.
According to clinicaltrials.gov, Pfizer–which has invested heavily in Alzheimer’s R&D over the years–opted to end the study of PF-05212377 on Oct. 23 based on futility, or a conclusion that the drug would fail the key endpoint laid out for it. The move puts the spotlight on the drug’s mechanism of action, raising fresh questions about the likely efficacy of other drugs that try to safeguard cognitive abilities by targeting the serotonin 6 receptor (5-HT6).
Anavex’s approach is completely different and this is the key. It’s the science behind Anavex that will make the difference. ANAVEX 2-73 is the most promising drug being developed right now for Alzheimer’s. ANAVEX 2-73 is based on oxidation and nitration causing Alzheimer’s. Other drug companies have instead focused on the cause being amyloid. They have misdiagnosed the cause while we believe Anavex has the correct approach.
Just don’t take our word for it, look at the results. First up is the positive dose-response data that has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer’s disease. The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.
The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects, with no adverse events reported above grade one.
We should be getting the 12 week update by February 9 via a press release or Dr. Missling will announce the results at the BIO & CEO Investor Conference. His presentation will take place on Tuesday, February 9, 2016 at 1:30 p.m. ET at the Waldorf-Astoria Hotel, Conrad Suite, in New York, NY. The 18th Annual BIO CEO & Investor Conference is hosted by the Biotechnology Industry Organization. It is the largest independent investor conference focused on established and emerging publicly traded and select private biotech companies. This is the perfect time for Dr. Missling to update the biotech community and shareholders.
Some of the money that came out of AXON has gone into AVXL as investors are realizing that AVXL is the best bet for biotech investors looking to bank on an Alzheimer’s drug. We are only days away from some potentially groundbreaking news. We will be updating Insider Financial with the latest developments from the conference. Sign up to Insider Financial today and get the latest updates on AVXL!
http://www.insiderfinancial.com/anavex-life-s...rs/114365/
Fletch
Anavex Life Sciences Corp (NASDAQ:AVXL) Best Bet For Alzheimer’s
FEBRUARY 3, 2016 BY ALEX CARLSON LEAVE A COMMENT
The news that Pfizer Inc (NYSE
FE) has shuttered its Phase II Alzheimer’s drug study has sent shock waves through the biotech world. Shares of Axovant Sciences Ltd (NYSE:AXON) got hammered on the news. The Pfizer news has deep ramifications for Axovant’s Alzheimer’s drug which has the same mechanism of action as Pfizer’s. While this has left investors in Axovant with many questions, the one answer we came up with is that Anavax Life Sciences Corp (NASDAQ:AVXL) looks like a better bet for the treatment of Alzheimer’s with ANAVEX 2-73 than ever before. According to clinicaltrials.gov, Pfizer–which has invested heavily in Alzheimer’s R&D over the years–opted to end the study of PF-05212377 on Oct. 23 based on futility, or a conclusion that the drug would fail the key endpoint laid out for it. The move puts the spotlight on the drug’s mechanism of action, raising fresh questions about the likely efficacy of other drugs that try to safeguard cognitive abilities by targeting the serotonin 6 receptor (5-HT6).
Anavex’s approach is completely different and this is the key. It’s the science behind Anavex that will make the difference. ANAVEX 2-73 is the most promising drug being developed right now for Alzheimer’s. ANAVEX 2-73 is based on oxidation and nitration causing Alzheimer’s. Other drug companies have instead focused on the cause being amyloid. They have misdiagnosed the cause while we believe Anavex has the correct approach.
Just don’t take our word for it, look at the results. First up is the positive dose-response data that has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer’s disease. The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.
The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects, with no adverse events reported above grade one.
We should be getting the 12 week update by February 9 via a press release or Dr. Missling will announce the results at the BIO & CEO Investor Conference. His presentation will take place on Tuesday, February 9, 2016 at 1:30 p.m. ET at the Waldorf-Astoria Hotel, Conrad Suite, in New York, NY. The 18th Annual BIO CEO & Investor Conference is hosted by the Biotechnology Industry Organization. It is the largest independent investor conference focused on established and emerging publicly traded and select private biotech companies. This is the perfect time for Dr. Missling to update the biotech community and shareholders.
Some of the money that came out of AXON has gone into AVXL as investors are realizing that AVXL is the best bet for biotech investors looking to bank on an Alzheimer’s drug. We are only days away from some potentially groundbreaking news. We will be updating Insider Financial with the latest developments from the conference. Sign up to Insider Financial today and get the latest updates on AVXL!
http://www.insiderfinancial.com/anavex-life-s...rs/114365/
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