missy68
3 days ago
SAN FRANCISCO, CA / ACCESSWIRE / July 23, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (βJaguarβ) today announced the results from its initial analysis of the pivotal Phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Crofelemer is an FDA-approved prescription drug for the symptomatic relief of diarrhea in adult HIV/AIDS patients receiving antiretroviral therapy. The initial results from the OnTarget study show that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary endpoint for the prespecified analysis of all tumor types in the trial.
βWhile the results of the OnTarget study did not achieve significance for all tumor types receiving various targeted therapies, I am pleased that the subgroup analyses show that crofelemer provides clinically meaningful improvement in the prespecified subgroups of breast and respiratory tumor patients. Clinical meaningfulness of these results is based on the information provided by solid tumor patients from a survey that informed us about the appropriate clinical study design and clinical endpoints, that are important to the patients in this prophylactic trial. We will continue to evaluate important OnTarget findings, with further analyses,β said Pablo Okhuysen, MD, Professor of Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, who is the Principal Investigator of the OnTarget clinical trial. βIt is important to note that the prespecified secondary outcomes for this study were based on outcomes that were considered to be meaningful by patients experiencing diarrhea due to targeted therapy.β
KEY TAKE-A-WAYS FROM ONTARGET TRIAL
Β· Unprecedented OnTarget trial included patients with 10 different tumor types and 24 different targeted agents, with and without multiple standard cytotoxic chemotherapies.
Β· Study did not meet prespecified analysis of primary endpoint for all tumor types.
Β· Analysis did reveal clinically relevant signals for patients in the prespecified subgroups of breast and respiratory cancers, including lung cancer, who received targeted therapies. These subgroups of patients comprised over 75% of the patients in the trial.
Β· Breast and lung cancers are two of the three most common cancers, with patients often remaining on targeted therapy over prolonged periods.
Β· A growing and urgent unmet medical need exists for novel non-opioid chronic agents to treat CTD.
Β· Results indicate positive signals improved over the initial 12-week phase of study; data for additional 12-week extension phase yet to be analyzed.
Β· Company expects to engage with FDA after full review of data.
timberwolf7
3 days ago
Not a lot of folks 'paying' attention this morning based on the volume activity..
Going to be interesting to see what the company says if anything about the potential
revenue from this product if the PH 3 is good..
I see someone said BILLIONS.... I would be hesitant with this number and wait for
the company to give their projection
Note: given their CURRENT low revenue numbers, and the low activity/interest level,
I would expect this to get shorted post the announcement. Especially since I would
expect them to do a secondary offering to raise cash (dilution)
Disclaimer: I decided yesterday based on the 'low interest'/trading, to lock in the gains I had.
Yes, I might miss something, but if this pops on the open?? I wouldn't be slow to take at least
some of the gains you get. And if I am wrong, won't be the first time I mis-read something.
GOOD LUCK
ShadowDiviner72
4 days ago
Finally, we arrived to the day we have been waiting for since November 2023. I want to highlight 1 fact:
"Since all patient data will be included in the final locked database, we will remain blinded and will announce the comprehensive results of the full trial, including Stage II results, rather than proceeding with the original plan of announcing top line results for Stage I only.
So many patients chose to continue the treatment, that they couldn't have a intermediate data readout in november last year. SUPER BULLISH on those results. Don't forget that the primary endpoint are Patient Reported Outcomes (PRO's) GLTA
timberwolf7
4 days ago
with the SMALL number of shares outstanding, one would think good news could
lead to some upside movement.
But at the same time, those SHORT and holding onto their positions could put a damper
on things in a hurry IF there aren't a lot paying attention to the news
all going to hinge on what they say, how loud they say it, and IF the market is again, paying attention.
Its tried to move higher 2x today and got dragged down in response..
pick your reason.. See what it does into the close..