Taxotere Nanoparticle Trial

[jal1954]

Greetings, I added to my post way below to provide an update, but it may not be readily visible, so I want to repeat it and elucidate.

I commenced participation in a clinical trial at MD Anderson on 2/21/17 to study the effects of CRLX-301, a nanoparticle formulation of Taxotere. I received two infusions without side effect, but was denied the third due to low neutrophil count. That has been resolved, and I reported on 3/21 for clearance to continue.

When I met with the lead trial doctor, she informed me that the trial was discontinued. From what she told me, I was able to research the situation and learn that not only did the company kill the trial, they just went broke for all intents and purposes and were acquired by another company. For more of the gory details, see: seekingalpha.com/news/32521....

Nota bene: “Cerulean has entered into an agreement with NewLink Genetics subsidiary BlueLink Pharmaceuticals for the sale of product candidates CRLX101 and CRLX301 for $1.5M…” Cerulean is defunct and the intellectual capital, and physical assets for its two drugs, its reasons for existence, were sold off to a third company.

What the acquiring company will do with these is undetermined. All of this happened this week. I located the website of NewLink Genetics; there were two innocuous email addresses posted, [e-mail] and [e-mail]. I wrote an email to these addresses and informed them of how Cerulean's failure impacted me and a plea to continue to make these drugs available to patients who rely on them. Amazingly, I received a reply from the CFO less than 24 hours later.

Do I believe my email will have any appreciable effect? Probably no. But I'm glad I communicated with them.

So, if you want to try to make a difference, please email NewLink Genetics and just encourage them to continue the trials of CRLX-101 and CRLX-301. The latter is more in jeopardy; 101 is on a fast track.

For me, I'm back in limbo. I will see my primary medical oncologist next week to make a plan. I will probably recommend a course of some combination of Docetaxel (I was already taking it in nano form), Cabazitaxel, and Carboplatin. I am deliberately not going to Zytiga or Xtandi, since those would make me ineligible for MDA's DYNAMO trial. The onc may just tell me it's time for DYNAMO; my concern is what comes after?

Thanks for your attention,

John

[jal1954]

Great news today. The acquiring company will continue the existing trial.

Quite a relief for me and the other patients. Hat's off to Cerulean, who got it all started, but couldn't weather the financial storms.

[wrando in reply to jal1954]

Do you have a link to the trial...or name?

[jal1954 in reply to wrando]

From what I understand, they are going to resume the trial for existing patients, but not take new ones.

[wrando in reply to jal1954]

sounds interesting... too bad

thanks

[jal1954 in reply to wrando]

Are you near Houston? There are many other trials underway at MDA. One of them might be good for you.

Here's one that was of interest to me, when I thought the first trial was dead.

mdanderson.org/patients-fam...

Regardless of where you are, there are many trial options available to you. It's much less difficult to find them now. Here's a link that a friend sent me to help find a trial.

ciscrp.org/our-programs/sea...

Good luck; I hope you find something that works for you.

[wrando in reply to jal1954]

Yea thanks...I'm looking, but I'm in CT. I'm hoping to find something.