INFO please...re. cediranib fate

[Katrinauk]

Just another quick note, I contacted my media agency team, and they are interested in doing a printout of the story, but need to go through a process of their own which involves looking into the possible story. Which I have told them, I can provide all the evidence they need that this story is infact not untrue. So therefore should be hearing from them pretty soon about setting up an interveiw.
Seems iv managed to contact all the correct people so far with the nesissary information need to understand fully, and fLex some form of action from here on in.

[Bonni Hess]

Dear Amazing Katrina,
WOW! You are a one woman army with all that you have accomplished thus far in pursuing this very concerning issue! I am very encouraged by the information which Professor Judson thoughtfully shared with you regarding the possibility of some other company or medical institution taking over the intellectual property of Cediranib which would enable the continued manufacture, formulation, and distribution of the drug. This is VERY welcome and relieving news after the extremely concerning and disturbing information contained in the response which you received from corporate medical directors at AstraZeneca. Especially troubling is their statement that "What we have to be transparent about is, of course, we cannot guarantee supply of the drug for an indefinite duration since this will depend upon our residual stocks of cediranib and the expiry date." This has potentially tragic implications and repercussions for any ASPS patient who may be having a successful response to the Cediranib but once the residual supply of the drug is gone, would no longer be able to access it which would result in an abrupt discontinuation of the drug which could cause devastating rebound and rapid disease progression!
I am continuing to pursue all avenues to raise an awareness in the ASPS Community and medical community of this very serious issue, and hopefully generate some help in appealing the decision and/or finding an acceptable resolution to it which would guarantee ASPS patients continued access to Cediranib, now and in the future.
I deeply share Amanda's frustration about the VERY disappointing lack of response and participation from CureASPS members on this Board regarding this critically important matter which ultimately affects EVERYONE with ASPS. We all need to work together to fight for the right for ASPS patients to receive promising new treatment drugs, and to not allow them to be taken away based on profit motives. The burden for doing this CANNOT and SHOULD NOT be carried by just a few. We are all busy and we are all immersed in fighting this insidious disease, but no one else is going to fight for the rights of patients with an extremely rare disease like ASPS to have access to promising new medications, and the harsh reality is that without new medications and treatments, precious Lives WILL be lost. PLEASE GET INVOLVED, PLEASE PARTICIPATE, AND PLEASE HELP IN ANY WAY THAT YOU CAN! This is truly a matter of Life and Death!
With special caring thoughts and continued Hope,
Bonni

[Katrinauk]

Hi Bonnie,
Thankyou for the encouraging compliment. When I put my head to something, I go full steam until there is a result, I intend to do the same with this worrying issue. I just feel, that if I can do all I can and provide crucial information for everybody, then at least we all know where we stand at least.
My only concern for the possibility that NCI resume responsibility for the intellectual property, and hence therefore produce and distribute again. I question as to whether transfer of the drug will be possible to the UK or other countries. If it means only US patients can gain access, or those who can afford to commute back and forth to gain access, can have the drug. What about those who need it and can't reach it? I may just email prof.Judson and service he knows the ideas behind how widely distributed cediranib will be, if NIC take it on.
Although, it is a very positive action being contemplated. Which I only hope and pray will go ahead, and continue to help asps patients until the trial is completed and the drug approved.

I completely agree, that it is a very sad fact that we are the only board members looking out for our fellow asps warriors!
Although we also have to respect that some may not be comfortable, or feel it is pointless to go up against such a big issue.
Some like myself, may not have anybody that wants to research for hell, and if a single patient with very little support when it comes to such issues, may not feel well enough to deal with it.
Personally that's not the type of person I am, but as individuals, we must do what we are capable of to help one another and not just ourselves.
We are a minority, so let's show them that we are infact stronger when united, and take a stand for what our rights as living human beings are, terminal diagnosis or not. Everybody from the moment they are born have a terminal diagnosis, what makes us any different?

[Bonni Hess]

Dear Katrina,
I absolutely understand and agree with your concern about what may happen regarding international access to Cediranib for ASPS patients outside of the USA if the intellectual property is transferred to NIH or another American based medical institution or company. This is certainly one of the issues which will need to be addressed and hopefully resolved to ensure continued availability of Cediranib to ASPS patients throughout the world. CureASPS President Yosef Landesman is continuing to pursue communication with those involved in this decision as well as members of the oncology community and hopefully will have additional information to share soon. At my request, he is also going to post the information about AstraZeneca's decision to discontinue development of Cediranib on the Home page of this Web site to hopefully generate more ASPS Community awareness and participation in appealing the decision from those who may not be following this Discussion Board Cediranib topic and updates.
With special caring thoughts and continued Hope,
Bonni

[Katrinauk]

This is a link the listing of departments and contact details at the National Cancer Institute (NCI), I am thinking that somebody should contact the correct department to enquire about the contemplating taking place in regards as to whether they will take on the intellectual property from astrazeneca, and continue production, manufacture and distribution of the cedirinib trial at phase two. After speaking with correspondants at astrazeneca about their decision, I really do not believe that we can appeal against their final decision to end the trial. Although, I do think the next approach would be to move our efforts toward NCI and encourage the decision to persue responsibilty of the cedirinib. Maybe if we all write a letter/email to pleed with them, and basically beg for their help with prolonging so many of ours and future asps patients lives.


http://www.cancer.gov/researchandfunding/contacts

[Katrinauk]

FABULOUS AND EXCITING NEWS GUYS!

Hey guys,
I have just recieved a call from my trials nurse, and they informed me that astrazeneca and prof.judson had contacted them regarding my emails to them stating my appeal of the discontinuance of cediranib. It turns out, somwhere within this last week, astrazeneca have now amended their decision, and will be continuing manufacture and distributing cediranib until the end of 2015!!!!!!!

RESULT GUYS!

happy treatment!

WWOOOOHHHOOOO!

[Amanda]

YAY!!!! )
Ok, my day is made !!
Until 2014 we can all breath .. But, unless there is another drug for 2015 be ready to fight again This time everyone needs to get involved!

[Olga]

Katrina, this is a fabulous news, it shows that even one proactive person can make a difference - I am so impressed! I hope that Brittany will receive an amended note from the Astra Zeneca in her trial in Canada re. the length of the expected drug availability in that trial if her clinical benefit continues. Astra Zeneca seems to be very sensitive to the publicity acts and aslo very responsive to the communications with the patients - when it was just starting we advocated for an ASPS trial to be open in US after the drug shown very good results in UK (first trial with Pf.Judson) and it gave them some assurance that with help of the community based web-site the info about enrollment into the ASPS trial will be spread wider and they can achieve their enrollment goals.
But the sand part for me is that even for ASPS the enrollment is coming to an end and there is no hope that cediranib will be ever approved for ASPS treatment. The drug is def. active although the activity is time limited in most cases and I was hoping that after successful completion of the cediranib-only trial they could proceed with the combination trials to find out the needed additional drug that could capitalize on the changes caused by the cediranib and completely kill the ASPS tumors. So sad that they are not going to proceed with the cediranib development.

[Bonni Hess]

Dear Katrina,
THANK YOU SO VERY MUCH!! for this WONDERFUL NEWS!!, and for all that you single handedly did to make it happen! However, while I applaud and celebrate AstraZeneca's amended decision to extend the length of time that Cediranib will now be available to currrent patients until the end of 2015, I echo and agree with all of Olga's thoughts and concerns regarding AstraZeneca's apparent decision to still discontinue development of Cediranib. Through your very pro-active and commendable efforts, current ASPS patients have thankfully won a partial victory, but the extremely disturbing fact remains that this very promising new drug will not be available to current or future ASPS patients after 2015, and it will not be available for use in combination trials with other drugs, which could potentially prove to be more effective than Cediranib-only trials. Our efforts and the battle MUST continue to win a total victory in convincing AstraZeneca, or some other pharmaceutical company or medical entity to continue research and development of Cediranib.
I think that the online petition which you suggested, as well as individual communications to NCI as you recommended are excellent ideas. Hopefully, now that you have proven that individuals CAN make a difference, more ASPS Community members will get actively involved and we can ALL work together on this issue of such immense importance to EVERYONE in the ASPS Community.
With ongoing deepest gratitude for all of your determined efforts and valued sharing, and with special caring thoughts and continued Hope,
Bonni

[Katrinauk]

Hey all,
By no means is our battle over. By this amended decision, it verifies that our voices are heard with efforts, and being listened to with heart.
We must not forget the crucial information that prof.judson mailed me, that NCI (NATIONAL CANCER INSTITUTE) not NIH, are still contemplating whether to resume responsibility of the cediranib . If NCI decide to resume responsibility, then they will be aiming to complete the cediranib through phase two and approve.
So let's not jump the gun and assume that the trial will not be complete persae.
We now have the blessing of more time to explore further information on thebintentions NCI have, and we can Target our efforts at NCI as I have previously stated.
It may be baby steps, but we have made progress, and now we move on to the next step- convincing NCI that US asps patients are seeing great response, and future asps patients need this drug readily available.
Have faith, strength and hope that together we can live mountains, if not, then I intend to on my own that's for sure!

Much love
Katrina.

[Olga]

Bonni, I am wondering as how to make the Brittany success known to NCI? Since Brittany's great success story is happening on a Canadian Phase 1 ced. trial, people at the NCI might be not aware of it (i.e. it is a different trial and they report to Astra Zeneca directly so the info surpasses the other places). May be you could talk to Dr. and ask him what he can do to let them know about her case? He leeks like a very dedicated person and since the future of the cediranib might now depend on a NCI decision to take the trial over, he might want to back us up?

[Amanda]

I agree with Olga... We need to show and not hope that they know about the help it is giving our ASPS family!
I am also going to be talking to some Oncs an i am going to ask them to try and get involved...

[Bonni Hess]

Dear Olga,
That is an excellent point as I had (perhaps naiively) assumed that AstraZeneca was making all Cediranib Trial results data available to all of the participating Cediranib research facilities and principal investigators. However, you may be correct since Brittany's Trial was a Canadian Trial and not a Cediranib only Trial, but rather a combination Cediranib/Rifampicin Trial open to patients with several different types of cancer with the purpose of determining if Cediranib had an adverse effect on Rifampicin which is a drug used in the treatment of tuberculosis. The premise of the Trial was that if Cediranib was successful in treating the major cancers which it was targeting, then AstraZeneca wanted to determine if Cediranib would interfere with the effectiveness of Rifampicin on cancer patients with tuberculosis because tuberculosis is so widespread in many third world countries, and successful treatment of it is extremely critical. Brittany of course was not personally affected by the tuberculosis issue, but it was the only Cediranib Trial open worldwide at the time of Brittany's enrollment in it, and it gave us a way to access Cediranib treatment for her. She was only on the Rifampicin for one week at the very beginning of the Trial which apparently fulfilled the study criteria for testing the Rifampicin issue. My personal e-mail communications with Professor Judson at Royal Marsden and Dr. Kummar at NIH during the past couple of years of Brittany's Cediranib Trial, have indicated to me that they were personally unaware of Brittany's treatment success. I will personally write to NCI to share Brittany's successful Cediranib results thus far, and will also discuss the issue of sharing Brittany's information with Dr. Sawyer when he returns since he has been away from his office and out of e-mail contact for the past two weeks. Also Yossi has written to tell me that he is pursuing and making progress in arranging discussions with both AstraZeneca and Dana Farber, and he will update me with the results of those discussions next week. He has also requested that Katrina send him a draft of her proposed online petition which he will then post on the Home page of this Web site along with updated information on AstraZeneca's decision so that the information is more visible to ASPS Community members who may not be following this specific Cediranib Discussion Board thread.
With special caring thoughts and continued Hope,
Bonni

[Katrinauk]

Hey guys,
I also agree, as I previously mentioned when we were focused on astrazeneca before gaining the knowledge about nci, was to individually write to them telling them our personal stories on cediranib, if everybody who has had some form of positive response was to do this, all may be contemplated further. As I said, our efforts should now go toward NCI, and again as the plan to astrazeneca.
Considering the trial Brittany was originally placed on which then amended to cediranib only, it is drfinately a wise move to inform astrazeneca and NCI of her response. If astrazeneca are not aware, it may be just what they need to add to the cediranib data to maybe reconsider further about closing the trial end if 2015.
Personally I think we still need to work on astrazeneca to try and persuade a changed decision, so there would then be global access to cediranib still.
We have four years to work on NCI, and prof.judson has already informed me that when he knows more about NCI's thought process, he will let me know. So he's keeping me in the know.
As I said, I plan on getting the petition running by next week. As soon as this is done it will certainly be forwarded.
With US uniting and now all my docs in England on our support system, I sure hope to see more results.
Love from England.
Katrina.

[Olga]

It turns out that we are not the only group that is interested to see the further cediranib developments:
European Journal of Cancer has just published an article:

Cediranib monotherapy in patients with advanced renal cell carcinoma: Results of a randomised phase II study
http://www.ejcancer.info/article/PIIS0959804911010719

Their conclusion:
Cediranib monotherapy demonstrated significant evidence of antitumour activity in patients with advanced renal cell carcinoma.

May be we should contact the group (I think there is a RCC group?) to coordinate the efforts or at least to let them know about the possible plans to stop cediranib development?