The CUDC-907 dose to be used in phase II studies will be 60 mg on a 5-days-on/2-days-off dosing schedule, according to Dr. Anas Younes of Memorial Sloan Kettering Cancer Center, New York, and his colleagues. A dose-expansion trial of this dose is ongoing, and the drug appears to be useful in particular for patients with refractory and relapsed diffuse large B-cell lymphoma.
The researchers tested CUDC-907, which is designed to inhibit histone deacetylase and PI3K enzyme pathways, for overall safety and response in 44 patients at four cancer centers. All participants had lymphoma or multiple myeloma and were refractory to treatment or had relapsed after two or more previous regimens.
The 44 participants were sequentially assigned to 21-day cycles of CUDC-907: 10 to once daily, 12 to twice weekly, 15 to three times weekly, and 7 to daily for 5 days followed by a 2-day break. The maximum tolerated doses were 60 mg for the once-daily schedule, 150 mg for the twice-weekly schedule, 150 mg for the three-times-weekly schedule, and 60 mg for the 5-on/2-off schedule. At data cutoff, 37 of the 44 patients had discontinued CUDC-907 because of disease progression, Dr. Younes and his associates reported in a study published online (Lancet Oncol. 2016 Mar 31. doi: 10.1016/S1470-2045(15)00584-7).
Four dose-limiting toxicities occurred in 3 of 40 evaluable patients. Grade 3 or worse adverse events occurred in 19 of 44 patients: 9 had thrombocytopenia, 3 had neutropenia, 3 had hyperglycemia. Adverse events led to dose reductions in six patients and treatment discontinuation in seven.
Of 37 response-evaluable patients, two had complete responses and three had partial responses. All five were seen in the subgroup of nine patients with diffuse large B-cell lymphoma, and three occurred in the five patients with transformed follicular disease. The 21 patients with stable disease included those with diffuse large B-cell
dont forget baker brothers bought in and then next quarter doubled down. im sure they saw the P1 results for 907 and took notice. yes share price is not moving untill they have more data. if there is any movement from the start of ca 170 im sure it will be short lived. the general market sell off doesnt help matters. most of the price erosion the last few days is from that.
I was being facetious about the paycut. Management has to be responsive to the owners; First Eagle has owned 20% of the common stock for over a decade. I am confident if they felt management was unethical, it would have pulled up its stakes by now. Plus why did Black Rock increase its holdings?
The share price always hinges on news; there has been a dearth of it lately, something has got to give.
tarh, the ONLY thing I am really really hoping and praying is that these fellas are not cheats. So many small biotechs are populated by cheats and #$%$s who play the game this from one ER to next. Raise money pay themselves and keep the stuff going. The delay with this makes me highly highly highly suspicious that Ali is a #$%$ but my faint heart still hopes for the best. Take me to break even and I am out. Good luck to all those who hold position here with this management. They are simply in NO HURRY AND THAT IS WHAT CONCERNS ME A LOT.
Pay cut is not going to happen since the director board is again all in coordinated effort. I am curious to know who the major holder here is and why are they still lingering around. Any thoughts on that??
I think we hear something positive on 907; it's targeting an unmet need for a not insignificant sub-population of R/R DLBCL patients and I am not aware of any competitors; if CEO commits to filing an abstract for ASH, that would be a positive.
still a POS management ............that does nothing to enhance shareholder value.............what do 44 people all day long..................
yeah and pigs will fly out Alis #$%$. got a feeling they are going to rehash the same old tired 907 P1 results and say everything is on its way. just hope they dont postpone the ca170 start to second half of 2016. wich is very likely with these clowns.
1. 907 Ph2 trial proceeding smoothly; expect to show a higher percentage of CRs and PRs than in Ph1 now that 907 is targeting MYC altered R/R DLBCL patients.
2. Plan to file an abstract at ASH conference regarding 907's progress in Ph2 as well as Ph1 solid tumor.
3. Filing IND for CA-170 after close of earnings conference
4. Management will take a 50% pay cut, to be restored when PPS exceeds $4 for more than 5 consecutive days.
Haha or he is losing. CRIS is tanking
I am increasingly convinced as each day goes by that these #$%$s are playing us for their salaries. The DLBCL platform is going to get pretty crowded soon and these MFs are sitting on this for years and years with some results of a ph1 trial. Pdl1 inhibitors are also advancing in clinical trials and the #$%$ Ali and team know it very well.
The only option owe of us who have positions here is to atleast call these MFs and ask what the f$&@is going on. What is the market position for cuscus 907 when eventually a decade from now it gets through???? What is the explanation for the 2 million pay check when he has not achieved anything to date???
This is horrible and I am not at all looking forwards to hear e MF repeat the story about the 18 evaluable responses in the ph1 trial.
Good luck to all and if you do have 10k or more vested here please call them repeatedly to see the progress. They are cheating us.
about the Ph1 results of cudc 907 the moron will be repeating the story on May 9th. At this point if I were responsible for the PR, I would advice the idiot to take a vacation and simply for mohindru or somebody else to just play the tape. They can then just reuse the tape for the next ER.
However, folks who play for few dollars might push this one up in anticipation of the "significant news" that Ali might release and then they will bring it right back to where it is now or lower.
The worst is that this idiot Ali is making over two million per some information that we are aware of.
Ali and other cheats in the director board need to get moving if they dont do something worthwhile for the investors. They simply cannot play the tape of cudc907 Ph1 results for one decade and get to take home two million in salary per year. Hopefully all of you voted NO to all the points in shareholders vote.