celgene's therapy ozanimod heading to phase 3 due to promising results from phase 2 for UC

celgene's therapy ozanimod heading to phase 3 due to promising results from phase 2 for UC
http://ibdnewstoday.com/2015/10/27/ulcerative-colitis-celgenes-therapy-ozanimod-shows-promising-results-phase-2-trial/

Ya I was offered this trial today actually. Although the difference in drug vs placebo is comparable to other biologics, its overall remission rate it quite low

TotesMagotes said...
I read up on Morgensen (is it also be called Mongersen?). I read that its only for Chrohn's due to wear its breaking down in the colon and won't apply to left side?

However the results are very positive. My GI is telling me there are a lot of oral biologics in the pipeline...that are not anti-TNF agents.

Do you have a link I cannot find anything saying it is ineffective for UC.

It is an anti-sense drug.

I was talking to Celgene about its trial for UC for weeks so I cannot believe the person was that confused for that long but it is possible.

Crohns is the larger market so they go for that first.

www.investorvillage.com/smbd.asp?mb=341&mn=196403&pt=msg&mid=14780274

CELG has indicated that the GED-301 program in ulcerative colitis is set to begin 2H15.

"Phase 3 program comes next. As part of GED-301's registration program, CELG

has initiated an endoscopic outcomes trial evaluating endoscopic changes after 12

weeks of treatment with the 160mg dose. Two large-scale P3 trials are expected to

initiate in Crohn's by mid-year with data anticipated by 2017. Further, CELG has

indicated that the GED-301 program in ulcerative colitis is set to begin 2H15. For our

part, we model US launch in 2018."

ir.celgene.com/releasedetail.cfm?releaseid=890827

Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results

Initiate enrollment in phase III trials of GED-0301 in Crohn's disease

Initiate clinical program in ulcerative colitis for GED-0301

Post Edited (aguywithuc) : 10/28/2015 8:44:57 AM (GMT-6)

TotesMagotes said...
Because the active compound of mongersen is released in the terminal ileum and right (proximal) colon, we excluded patients with known lesions in the stomach, proximal small intestine, transverse colon, or left colon. Patients were also excluded if they had strictures, fistulae, perianal disease, extraintestinal symptoms, active or recent infections, or a history of cancer.

http://www.nejm.org/doi/full/10.1056/NEJMoa1407250?af=R&rss=currentIssue&#methods

Under methods. I assumed since it excluded left side in trials it would not be something effective for left siders. I would LOVE to be wrong on thinking this.

Thanks. They also exclude people who have UC because this is a Crohns trial. The fact that they specifically mention adding a separate UC trial gives me hope. I can imagine where inflammation right before the ILEOCECAL VALVE results in problems in the large intestine so it could help some of us.

"Initiate clinical program in ulcerative colitis for GED-0301".

Marauder93 said...
Not sure if you guys just decided to go off track or if youre confused, but this is a small molecule, not an anti-sense drug. You are talking about a different drug all together

Well if you read my post you will see that I am not impressed with 21% remission when Celgenes other drug is over 70% effective for Crohns patients and a UC trial is also planned so we were trying to determine if it will be as successful because it release before the large intestine.

Marauder93 said...

aguywithuc said...

Marauder93 said...
Not sure if you guys just decided to go off track or if youre confused, but this is a small molecule, not an anti-sense drug. You are talking about a different drug all together

Well if you read my post you will see that I am not impressed with 21% remission when Celgenes other drug is over 70% effective for Crohns patients and a UC trial is also planned so we were trying to determine if it will be as successful because it release before the large intestine.

70% remission rate? Havent heard that before. Ill have to look into it. But this drug had a 58% response rate which is huge; better than remicade and Entyvio if memory serves

Good point! Thanks for mentioning that I missed it.

I was very high and Morgensen GED-0301 let me see if I can find the details.

Well from the link above it looks like I rounded up to 70% figure from 67% but the lack of side effects is the deal clincher for me.

- Impressive efficacy. As we saw in October, the higher GED-301 doses (40mg and

160mg QD) showed stat-sig improvements in remission rates of 55.0% and 65.1%,

respectively. Further, after 12 weeks of treatment, the 40mg and 160mg groups

showed stat-sig improvements in remission rates of 63% and 67%, respectively.

We note that CELG has indicated that P3 trials will include a 52-week treat-through

design so will provide longer-term efficacy data.

- Safety also impresses. Most AEs were mild and reported in 64% of the placebo

group and 65% of patients receiving GED-301. Nine SAEs reported, but no

significant difference between placebo and GED-301 groups.

Post Edited (aguywithuc) : 10/29/2015 9:16:03 AM (GMT-6)