US Clinical trial shows drug Rexin-G extends survival

[Nardobd]

I have found what seems to be promising news from clinical trials in the Phillipines and US. Epeius Biotechnologies have issued a statement that their drug, Rexin-G, raises one-year survival to more than 28%. The report on the clinical trial is carried by Reuters and can be found here: http://www.reuters.com/article/pressRelease/idUS94306+14-Oct-2009+PRN20091014

The company's website states "Epeius successfully completed its Advanced Phase I/II and confirmatory Phase II trials for pancreatic cancer, sarcoma, and osteosarcoma, respectively, with all primary and secondary endpoints achieved. Consequently, Rexin-G has received Fast Track Status and priorities from the U.S. FDA and is in the process of applying for accelerated approval(s) for these clinical indications". It also states that the drug IS appropriate for metastic cancer.

Epeius also have a video showing how Rexin-G works: http://www.epeiusbiotech.com/oncology-video.asp

I'm contacting the medical director of Epeius asking for more info. I'll report back when I get a response but in the meantime if you have an appointment with your oncologist you might want to mention this to them. I'm also contacting PCUK to ask them whether they can put any pressure on NICE to see whether fast-track approval might be granted in the UK (but don't hold your breath!).

Nicki

[Nardobd]

I received a very prompt reply from the medical director of Epeicus which is reproduced below:

I have attached the advanced online publication of our clinical trial published as an open access article in Molecular Therapy Journal (http://www.nature.com/mt/, click advance online publications, October 13, 2009). Rexin-G recently gained Fast Track Designation from the FDA and we are in the process of developing a Phase II/III study of Rexin-G as second-line treatment for pancreatic cancer. We expect that this study will open in the January, 2010. Rexin-G is also commercially available in the Philippines.

We are also developing a plan to open clinical trials and gain regulatory approval in the UK, but this will take a longer time, unless we can identify a pharmaceutical partner who will co-develop Rexin-G in UK. Meanwhile, we are able to export product to UK on a compassionate basis, if an import permit could be obtained from the UK FDA counterpart to import an investigational agent from the U.S.(usually obtained through a pharmaceutical company or distributor), and if a medical oncologist in UK would prescribe and administer the drug (we can do in-service training if needed), as well as certain financial considerations.

Thank you for your interest in Rexin-G. We would be happy to meet with any pharmaceutical or biotech company who can license Rexin-G for clinical development in the UK, or officials at NICE who may able to help UK patients gain access to Rexin-G.

Best regards,

Dr. Gordon

Erlinda M. Gordon, M.D.

Vice President, Operations and Medical Affairs

Founder and Chairman of the Board

Epeius Biotechnologies Corporation

475 Huntington Drive

San Marino CA 91108

Tel: 626-441-6695; Fax: 626-441-6692

Cell: 818-726-3278 (U.S.A.)

I haven't yet had time to read and digest the accompanying reports and am unable to upload them since they are pdf files which aren't permitted. However, if anyone wants the papers for an upcoming appointment with the oncologist please let me know by way of a reply to this post. I'll then try to work out a way of uploading them or sned them to PCUK for distribution.

Kind regards

Nicki

Kind regards

Nicki

[clair2305]

well, i've read those reports and looked at Epeius websit and read some more stuff, so this will be on my list for tomorrow's appointment.....

Back to more research

Clair

[Juliana]

I was just wondering if any of you guys had checked the 'trials' page on the main PC home page?

http://www.pancreaticcancer.org.uk/PCTrials.htm

There looks to be some promising stuff on there, with gene therapy and PDT (listed under VERTPAC). Wonder if there is anything there worth printing out and taking to the oncologist?

Juliana

[clair2305]

Hi Juliana

thanks for this information, however, I will warn you guys n gals, some of these trials are closed the the CancerHelp site has been "undergoing maintenance" nearly all day, much to my annoyance, trying to look for other clinical trials/information about treatments.

Hey ho, back to the drawing board

Clair

[clair2305]

I received a very prompt reply from the medical director of Epeicus which is reproduced below:

......We are also developing a plan to open clinical trials and gain regulatory approval in the UK, but this will take a longer time, unless we can identify a pharmaceutical partner who will co-develop Rexin-G in UK. Meanwhile, we are able to export product to UK on a compassionate basis, if an import permit could be obtained from the UK FDA counterpart to import an investigational agent from the U.S.(usually obtained through a pharmaceutical company or distributor), and if a medical oncologist in UK would prescribe and administer the drug (we can do in-service training if needed), as well as certain financial considerations.

Nicki

Hi Nicki

just wondering if you found out anymore information about Rexin G, I read the reports and looked at their website etc and it all sounds very interesting, I'm wondering if it would be suitable for Blue and how to go about it.....the phrases "compassionate basis" and "financial considerations" concern me, but I will be bringing it up tomorrow, I just hate it though, as I know Blue's doctor would want to give him anything to help, but let's be honest, he doesn't hold the purse strings does he?!?!?

Dreading tomorrow, don't know what treatment docotor has in mind, only London or Leicester.....aaaahhhhhhh!!!!!

[Nardobd]

Hi Clair

No, I haven't found anything else. I think the "financial considerations" bit is tied to the fact that they envisage that the import permit will be sought via a pharmaceutical company or distributor. They don't want to lose their advantage in the UK market and a payment would necessitate a contract which could have exclusivity clauses and restraint clauses to protect them.

However, whilst I think you should probably mention this to Blue's specialist, I wouldn't hold your breath. It would be a very brave doctor indeed who agreed to administer a drug outside of the confines of a clinical trial and without that drug being proven to have benefits which outweigh any possible side effects, both long and short term. There are a number of reasons for this including, potentially, a reprimand from the General Medical Council, criticism from NICE, indemnity insurance problems and a civil lawsuit. Even if the doctor is persuaded, he would then have to obtain permission from the Primary Care Trust.

That doesn't mean you shouldn't try, though! Blue deserves all the help he can get. Good luck for the appointment today and do let us know how you get on.

Nicki xx