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2/16/2017 3:48 pm  #1771


Re: disscussions about ohrp, wet amd, squalamine

His argument falls short on a few points, particularly his statement that cash "should easily fund the remainder of the study...". If he had bothered to read the 10Q he would have read that the company will only be funded until June. It's a 9 month endpoint. That's late October/early Nov, assuming the halt was within the last wk. Another month of data lockdown and analysis and we're at Nov/Dec, in accordance with Slakter's "by the end of the year.". 

It also means that no company was willing to take risk after Fovista's failure with the data that Ohr had &/or that OHRP was too greedy.

If the trial was partnered and came up short, but with SOME indication of efficacy, it opens the door for a successful 2nd Phase 3. Now, it's either meet 5 letters with p < 0.05 with N=200 or bankruptcy.

The 5 points that Slakter brought up as "differentiating factors" leading to expected success are highly suspect with NO evidence to support them, with one exception: there is some proof that occult lesion size correlates with success. But the statistics are marginal: just p values of 0.03. Fovista had far greater statistical significance in Phase 2 and look at what happened.
 

 

2/17/2017 7:11 pm  #1772


Re: disscussions about ohrp, wet amd, squalamine

I found the LifeSci report that provides a detailed explanation for the 5 points Slakter brought up. Posted on Yahoo board as well. We all know this is provided by the company for LifeSci to disseminate. Good arguments in some cases, poor in many others. The report claims 1501 results are expected this year. Might be nice if they had read the latest 10Q before writing a report... FWIW

https://www.baystreet.ca/articles/research_reports/lifesci/OHRP021417.pdf

Last edited by billwilliams836 (2/17/2017 7:11 pm)

 

3/01/2017 2:51 pm  #1773


Re: disscussions about ohrp, wet amd, squalamine

From OLSIRetina, 2017. Interim IMPACT data showed OCT correlation (presented by Boyer, AAO, 2014), but I found nothing proving there was a difference between arms in the final results. Boyer did not mention it at the 2015 AAO meeting in which he presented the final results. Without a correlation to anatomical effect, squalamine has the same issue as Fovista, only this time, we know to ask the question PRIOR to completion of a Phase 3 trial. "In November 2016, the data from the phase 2 Ophthotech study were published confirming the statistically significant vision gains in the combination Fovista/ranibizumab cohort over the ranibizumab monotherapy group.15 However, optical coherence tomography (OCT) findings demonstrated no meaningful or statistically significant differences between the groups receiving the combination versus monotherapy. This vision-OCT disconnect caused concern in that biological plausibility for the vision gains seemed to be missing in the phase 2 data."(15) Ophthalmology 2016 Oct 28. pii: S0161-6420(16)31636-0.

 

6/15/2017 1:04 pm  #1774


Re: disscussions about ohrp, wet amd, squalamine

 billywilliams did you listen to the presentation ?

 

6/20/2017 8:17 am  #1775


Re: disscussions about ohrp, wet amd, squalamine

I did and there still are no answers to the questions I posed. Slakter does know that he needs to convince investors that squalamine will not suffer the same fate as Fovista.This translates to proof that Phase 3 will replicate Phase 2; ie, that the drug arm truly does have additional benefit over the Lucentis-only control arm. The biggest threat to OHRP is that the 5 letter difference in Phase 2 is not reproduced in Phase 3. If only 4 letter improvement are seen, is it still a success? We don't know. 

Fovista had 0 letters in Phase 3 but very good Phase 2 VA results *supported* by anatomical and dose-response data. Squalamine has good Phase 2 VA (statistically much less than Fovista; ie more uncertain the difference is real) but the only supporting data is post hoc baseline occult lesion size (good correlation and best evidence as it was not found in the Lucentis-only control arm). Where are the OCT data between the arms??

Obviously, OCT scans were taken at the final visit. Since nothing was released, we can very safely assume there was no difference between the arms. Squalamine did not improve any anatomical feature relative to Lucentis (INCLUDING occult < 10mm**2)  So, is Phase 2 VA real or is it just chance?

 

 

6/22/2017 8:29 am  #1776


Re: disscussions about ohrp, wet amd, squalamine

Thank you for responding.
If the data at the end of the year shows the same improvement (5 letter) as in phase 2. would they have to still do a phase 3 ? In your opinion would the value be any where as high as Fovista was ?

 

6/22/2017 9:57 am  #1777


Re: disscussions about ohrp, wet amd, squalamine

Yes, they will have to complete 2 Phase 3 trials. This is just 1/2 of 1 of the 2 required. What is not clear is whether they are able to run another 1/2 or it would require fully powered enrollment.

The 5 letter gain might be enough. The endpoint was left ambiguous. Per Dec 23 LifeSci report: "The primary endpoint will be a measure of visual acuity at month 9. Mean letters gained or
the percentage of patients gaining 3 or more lines on a standard eye chart could be used.'

As to value, that all depends on the progress of alternative wet AMD approaches, particularly X-82 and anti-ANG2 molecules: RG7716 and nesvacumab. X-82 is oral, at Phase 2, results due Jan, 2018. Nesvacumab results are due Q3/4.

 

7/12/2017 9:26 am  #1778


Re: disscussions about ohrp, wet amd, squalamine

Good discussion by MD's Kaiser and Brown on wet-AMD landscape, sponsored by LifeSci. Very positive on squalamine prospects.

http://link.emaildir2.com/click/hksqm-b9ddce-1zy920h8/

 

7/12/2017 1:41 pm  #1779


Re: disscussions about ohrp, wet amd, squalamine

My notes:
1. Insurers are under-rated in terms of controlling the drug of choice. Payers are not convinced Eylea is better (more cost-effective) than Lucentis. Avastin is always pushed as 1st choice. Physicians know that Eylea is the true gold-standard for both duration of action and drying ability.
2. Squalamine may be useful as add on due to steady-state VEGF signalling reduction, not due to PDGF. Wall St wrongly groups squalamine with other "combo" (VEGF/PDGF) drugs not due to targets, but due to specific cell types that are differentially affected. Pericyte actions have seemingly failed, despite all the preclinical evidence. Squalamine acts on activated endothelial cells (the most relevant cell type for wet-amd).
3. Odds for squalamine Phase III success given at 50-60% vs just 10% (given prospectively) for Phase III Fovista. Recruitment criteria poor for Fovista Phase III.
4. Back to #1. Price plays a HUGE role in terms of patient/dr. acceptance due to reimbursement costs. It's much easier to provide a Rx than purchase the biologic and wait for possible rejection by insurers.
5. If Phase III fails to show vision improvements, there may still be an opportunity if duration (time between injections) can be demonstrated in another Phase III study. It was stated several times that we are already "at the top of the curve" for vision gains with current products. Incremental gains may be difficult to achieve and/or justify to insurers, though at the right price, a drop regimen will be accepted faster.

 

1/05/2018 6:58 am  #1780


Re: disscussions about ohrp, wet amd, squalamine

NEW YORK, Jan. 05, 2018 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases, today reported topline data from the MAKO study which did not meet its primary efficacy endpoint. The MAKO study evaluated the efficacy and safety of topically administered squalamine in combination with monthly Lucentis® injections for the treatment of wet age-related macular degeneration (“wet-AMD”). The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis. Subjects receiving squalamine combination therapy (n=119) achieved a mean gain of 8.33 letters from baseline versus 10.58 letters from baseline with Lucentis® monotherapy (n=118). There were no differences in the safety profile between the two treatment groups.“We are very disappointed with the outcome of the MAKO study,” commented Dr. Jason Slakter, chief executive officer of Ohr. “We are grateful to the patients and physicians who participated in the clinical trial. Based on these results, we intend to evaluate strategic alternatives to maximize shareholder value.”
--------------------------------

Well, that's it for OHR, I suppose.
BIG disappointment, indeed.
I expect the company to go bankrupt now.
Funds will be depleted in a few months time.
No drug company will be interested in this anymore.
I can't see how OHR could manage to get out of this one, now.
Sad, sad !!

 

 

3/23/2019 4:32 pm  #1781


Re: disscussions about ohrp, wet amd, squalamine

Josq

Thanks for that.   I take it then that its possible/normal/recommended that front or rear speakers can be wet while the other two lets say a 4 speaker stereo setup example would be "dry"?   I would think this would lead to a  sound that would be "off".   

Thank you for the explanation

Pat

 

4/06/2019 9:00 am  #1782


Re: disscussions about ohrp, wet amd, squalamine

Josq

Thanks for that.   I take it then that its possible/normal/recommended that front or rear speakers can be wet while the other two lets say a 4 speaker stereo setup example would be "dry"?   I would think this would lead to a  sound that would be "off".   

Thank you for the explanation

Pat

 

4/26/2019 5:43 am  #1783


Re: disscussions about ohrp, wet amd, squalamine

Hi im just wondering if you guys know what this wet spot might be in my 02 rsx?
I checked almost all of my oil and there are no leaks whatsoever. There is also no leak on the ground. It is just always been wet in this area of my rsx. Any thoughts? i took this photo from the rims, kinda dark but I took this from my front right rims.

 

5/09/2019 6:09 pm  #1784


Re: disscussions about ohrp, wet amd, squalamine

hi to all! give me plcase funny cats videozs on yourtube

 

5/18/2019 4:04 pm  #1785


Re: disscussions about ohrp, wet amd, squalamine

Hi im just wondering if you guys know what this wet spot might be in my 02 rsx?
I checked almost all of my oil and there are no leaks whatsoever. There is also no leak on the ground. It is just always been wet in this area of my rsx. Any thoughts? i took this photo from the rims, kinda dark but I took this from my front right rims.

 

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