Interesting OC Vaccine trial coming up

Hissy_Fitz

FDA Approves Immunovaccine's Application for a Phase I/II Clinical Trial for an Ovarian Cancer Vaccine

HALIFAX, NOVA SCOTIA--(Marketwire - June 20, 2011) - Immunovaccine Inc. (TSX VENTURE:IMV), announced today that the US Food and Drug Administration (FDA) reviewed and cleared its Investigational New Drug (IND) application for a Phase I/II clinical study with DPX-Survivac, a therapeutic cancer vaccine. DPX-Survivac will be tested in patients with ovarian cancer.

The DPX-Survivac vaccine candidate uses antigens from survivin (in-licensed from Merck KGaA) which are formulated in the DepoVax™ vaccine delivery platform. Survivin is a tumor-associated antigen that is present in cancer cells and generally not expressed in normal cells. Survivin is required by cancer cells to survive, making it a particularly interesting target to test in a cancer vaccine. The DepoVax platform is a patented vaccine delivery formulation that is expected to enhance an immune response targeting cancer cells that contain survivin.

"With few options available for treating advanced stage ovarian cancer, we are very pleased to get the green light from the FDA to begin this innovative clinical trial," said Dr. Marc Mansour, Chief Operating Officer and Chief Science Officer. "We have optimized the survivin antigens in our DepoVax formulation, and we have designed a trial that incorporates new concepts and recent advances made in the field of immunotherapy."

The Phase I/II multicentre clinical trial is designed to assess the safety, immunogenicity and clinical efficacy of the DPX-Survivac vaccine. Patients will be treated with the DPX-Survivac vaccine after completing debulking surgery and chemotherapy treatments. The vaccine will be administered to patients who will also receive an immune modulating drug to enhance the effect of the vaccine on cancer cells. The Phase I portion of the clinical trial design is an open label dose ranging study to identify the optimal dose of DPX-Survivac to use in the Phase II portion of the study. Immunovaccine expects to start the Phase I study in Q4 of 2011.

After a successful Phase I clinical trial, Immunovaccine will be permitted to initiate, without any further application to the FDA, a randomized double-blinded placebo-controlled Phase II clinical trial to assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.

The National Cancer Institute (NCI) has classified survivin as a promising cancer antigen on the basis of its specificity to cancer cells and its presence in tumor specimens from a high proportion of cancer patients. Survivin is found in up to 90% of ovarian cancers1. It is expected that DPX-Survivac will activate the body's immune cells to recognize and specifically kill cancer cells containing survivin.

Ovarian cancer has the highest mortality of all cancers of the female reproductive system. This reflects, in part, a lack of early symptoms and ovarian cancer screening tests. Ovarian cancer is often diagnosed at an advanced stage, after the cancer has spread beyond the ovary. It is estimated that approximately $2.2 billion is spent in the United States each year on treatment of ovarian cancer. [source: www.cancer.gov/cancertopics/types/ovarian]

softD

vaccine trials
Thanks for the info Carlene. I'm on the cvac trial atm...hoping
these vaccine trials will be the way of treating ovca in the
future for extended, and hopefully permanent remissions!
Carolyn x

carolenk

softD said:

vaccine trials
Thanks for the info Carlene. I'm on the cvac trial atm...hoping
these vaccine trials will be the way of treating ovca in the
future for extended, and hopefully permanent remissions!
Carolyn x

Immune modulating drug: Zadaxin?
Dear Carlene

I am trying to find out what is the "immune modulating drug" that is used in the trial. I am wondering if it is something called Zadaxin--a synthetic analog of thymus gland substance.

Zadaxin kicks in the gammadelta T cells that work with the dendritic cell vaccines. I found out about Zadaxin on the Internet and my family doctor was agreeable to prescribe it for me--only to find out that the drug is not available in the US! Ugh!

If you check out Zadaxin, you will see that it has been found to help vaccines work and it helps the immune system fight some cancers in general. It is indicated for metastatic prostate cancer and melanoma as well as Hepatitis B and C and for use with vaccines. Since there are a lot of similarities with prostate cancer and ovarian cancer, I was really interested in trying the drug.

I found out that it is possible for me to import Zadaxin for personal use--$2600 for 3-month supply. Yikes!

Since the vaccine trial is going on in Canada, I am was thinking maybe they were using Zadaxin with the vaccine. There are no clinical trials on the horizon for Zadaxin in the US--boo hoo!

Carolen

Tethys41

carolenk said:

Immune modulating drug: Zadaxin?
Dear Carlene

I am trying to find out what is the "immune modulating drug" that is used in the trial. I am wondering if it is something called Zadaxin--a synthetic analog of thymus gland substance.

Zadaxin kicks in the gammadelta T cells that work with the dendritic cell vaccines. I found out about Zadaxin on the Internet and my family doctor was agreeable to prescribe it for me--only to find out that the drug is not available in the US! Ugh!

If you check out Zadaxin, you will see that it has been found to help vaccines work and it helps the immune system fight some cancers in general. It is indicated for metastatic prostate cancer and melanoma as well as Hepatitis B and C and for use with vaccines. Since there are a lot of similarities with prostate cancer and ovarian cancer, I was really interested in trying the drug.

I found out that it is possible for me to import Zadaxin for personal use--$2600 for 3-month supply. Yikes!

Since the vaccine trial is going on in Canada, I am was thinking maybe they were using Zadaxin with the vaccine. There are no clinical trials on the horizon for Zadaxin in the US--boo hoo!

Carolen

Canada?
Can you travel to Canada for the trial?

carolenk

Tethys41 said:

Canada?
Can you travel to Canada for the trial?

US also doing clinical trial
Dear Tethys

I found an email address from one of the researchers and made an inquiry about the immune modulating drug. The vaccine trial is also going to be happening in the States and I made an inquiry about that, too.

Carolen

Hissy_Fitz

carolenk said:

US also doing clinical trial
Dear Tethys

I found an email address from one of the researchers and made an inquiry about the immune modulating drug. The vaccine trial is also going to be happening in the States and I made an inquiry about that, too.

Carolen

I haven't seen anything
I haven't seen anything published recently, but as of early 2011, the plan was to start clinical trials in the US this Fall.

Vaccines are often limited to patients in remission, but I don't know if that will be the case with this one or not. It just says, "after surgical treatment and chemotherapy."

This drug sounds very promising, but then, they all seem to be promising on some level. Sooner or later, one is going to be the magic bullet. I am confident of that.

Carlene

lulu1010

Hissy_Fitz said:

I haven't seen anything
I haven't seen anything published recently, but as of early 2011, the plan was to start clinical trials in the US this Fall.

Vaccines are often limited to patients in remission, but I don't know if that will be the case with this one or not. It just says, "after surgical treatment and chemotherapy."

This drug sounds very promising, but then, they all seem to be promising on some level. Sooner or later, one is going to be the magic bullet. I am confident of that.

Carlene

Carolyn X
I am just beginning this trial also. So glad to know someone else participating in this trial. Yes, one of these trials has got to be the answer we are all looking for.

Tethys41

carolenk said:

US also doing clinical trial
Dear Tethys

I found an email address from one of the researchers and made an inquiry about the immune modulating drug. The vaccine trial is also going to be happening in the States and I made an inquiry about that, too.

Carolen

Trial
I'd love to hear where and when the trial is taking place, when you find out.

Hissy_Fitz

lulu1010 said:

Carolyn X
I am just beginning this trial also. So glad to know someone else participating in this trial. Yes, one of these trials has got to be the answer we are all looking for.

Lulu....
I don't think any
Lulu....

I don't think any of us are participating in this particular trial. It's not supposed to be open in the US until Sept or later.

What's the FDA name of your trial? Mine is Globo-H-GM2-sTn-TF-Tn

Carlene

carolenk

Tethys41 said:

Trial
I'd love to hear where and when the trial is taking place, when you find out.

DPX-Survivac clinical trial
Here's the response to my inquiry:

Hi Carolen,

On behalf of Dr. Mansour, thank you for your interest in Immunovaccine’s clinical research.

We are presently meeting with several hospital sites in the U.S. interested in the DPX-Survivac clinical trial. We anticipate each hospital’s internal review board (IRB) will examine and approve the DPX-Survivac clinical trial protocol by the fall of 2011.

In approximately 4 weeks we will post the study inclusion / exclusion criteria to www.clinicaltrials.gov. Then by Sept / Oct we will begin posting the name and site address of each principle investigator to www.clinicaltrials.gov. The principal investigators will have additional information on the clinical trial. The immune modulating drug will be a low dose chemotherapy treatment, designed to enhance the performance of the DPX-Survivac vaccine.

Interested parties are encouraged to contact the principle investigator directly to learn more about clinical trial enrollment.

Regards,

Jennifer


Jennifer (Ayotte) Cameron, Communications Director

Immunovaccine Inc.

www.imvaccine.com  www.deliveringbreakthroughs.com

lulu1010

Hissy_Fitz said:

Lulu....
I don't think any
Lulu....

I don't think any of us are participating in this particular trial. It's not supposed to be open in the US until Sept or later.

What's the FDA name of your trial? Mine is Globo-H-GM2-sTn-TF-Tn

Carlene

Carlene
The CVAC trial is open and I am in it. Havent gotten the vaccine yet but had the aphoresis to make the vaccine. I did hear from someone in Austrailia who is also in the trial. Not sure of the FDA name ...will have to look it up.

Hissy_Fitz

lulu1010 said:

Carlene
The CVAC trial is open and I am in it. Havent gotten the vaccine yet but had the aphoresis to make the vaccine. I did hear from someone in Austrailia who is also in the trial. Not sure of the FDA name ...will have to look it up.

Yes, please do look up the
Yes, please do look up the FDA identifier. Carole and Teth are both very interested in this trial.

What hospital are you receiving the vaccine thru?

Carlene

lulu1010

Tethys41 said:

Trial
I'd love to hear where and when the trial is taking place, when you find out.

CVac trial
Havent found the FDA number yet...not sure I have it. It is being done by Prime Bio Med and it is being given in about 10 places in US and a few in Austrailia. It just opened. I am enrolled at Cleveland Clinic. I think I saw all the locations on the ACS Trial Finder but couldnt get the browser to work today. The number is CAN-003. If I run into anymore detailed info I will let you know.

Hissy_Fitz

lulu1010 said:

CVac trial
Havent found the FDA number yet...not sure I have it. It is being done by Prime Bio Med and it is being given in about 10 places in US and a few in Austrailia. It just opened. I am enrolled at Cleveland Clinic. I think I saw all the locations on the ACS Trial Finder but couldnt get the browser to work today. The number is CAN-003. If I run into anymore detailed info I will let you know.

Lulu....your trial is
Lulu....your trial is NCT01068509, if I'm not mistaken. And they are still recruiting for this trial.

Your trial sounds very interesting. It is not, however, the same as the Survivac trial, which is being led by Immunovaccine Inc. and is scheduled to start recruiting in the US in the Fall.

There are probably no less than a dozen vaccine trials going on right now for ovarian cancer. It's hard to keep them all straight.

The one I am doing does not require leukapheresis. I don't believe the Survivac vaccine does, either.

Here is a bit more about the Survivac vaccine:

About DPX-Survivac

DPX-Survivac uses Survivin-based antigens, in-licensed from Merck KGaA on a worldwide exclusive basis, and formulated in the DepoVax™ vaccine delivery platform. Survivin is a major tumor-associated antigen over-expressed in ovarian cancer cells, making it a viable target for immunotherapy. DepoVax will deliver the Survivin-based antigens in a lipid-depot format designed to generate a strong and prolonged immune response.

Carlene

antcat

Hissy_Fitz said:

Lulu....your trial is
Lulu....your trial is NCT01068509, if I'm not mistaken. And they are still recruiting for this trial.

Your trial sounds very interesting. It is not, however, the same as the Survivac trial, which is being led by Immunovaccine Inc. and is scheduled to start recruiting in the US in the Fall.

There are probably no less than a dozen vaccine trials going on right now for ovarian cancer. It's hard to keep them all straight.

The one I am doing does not require leukapheresis. I don't believe the Survivac vaccine does, either.

Here is a bit more about the Survivac vaccine:

About DPX-Survivac

DPX-Survivac uses Survivin-based antigens, in-licensed from Merck KGaA on a worldwide exclusive basis, and formulated in the DepoVax™ vaccine delivery platform. Survivin is a major tumor-associated antigen over-expressed in ovarian cancer cells, making it a viable target for immunotherapy. DepoVax will deliver the Survivin-based antigens in a lipid-depot format designed to generate a strong and prolonged immune response.

Carlene

Hi Carlene, saw your latest info and yes you're right I talked to the oncologist today and he told me that the trial is for people in remission. But, I advised him that the way I read it it's for people who are not in remission but have the disease. I'm going to see my gyn/onc in a month and I'm going to ask him about this. There is nothing listed yet about the inclusion/exclusion criteria so I'm going to keep looking.

P.S. Again, good luck with your hernia surgery on Tuesday 8/9. And, also I went for my 3rd cycle of chemo today (taxotere only) and they did a CA 125 test. My figure went up a point. I know it's probably not bad but still people worry. I think the oncologist told me last time that it takes about 2 cycles for the CA 125 to normalize, But mine is up to 10 now. Anyway, hope to hear from you after your surgery.

Thanks again for telling about this new trial. You are absolutely wonderful in sharing information with us.

lulu1010

Hissy_Fitz said:

Lulu....your trial is
Lulu....your trial is NCT01068509, if I'm not mistaken. And they are still recruiting for this trial.

Your trial sounds very interesting. It is not, however, the same as the Survivac trial, which is being led by Immunovaccine Inc. and is scheduled to start recruiting in the US in the Fall.

There are probably no less than a dozen vaccine trials going on right now for ovarian cancer. It's hard to keep them all straight.

The one I am doing does not require leukapheresis. I don't believe the Survivac vaccine does, either.

Here is a bit more about the Survivac vaccine:

About DPX-Survivac

DPX-Survivac uses Survivin-based antigens, in-licensed from Merck KGaA on a worldwide exclusive basis, and formulated in the DepoVax™ vaccine delivery platform. Survivin is a major tumor-associated antigen over-expressed in ovarian cancer cells, making it a viable target for immunotherapy. DepoVax will deliver the Survivin-based antigens in a lipid-depot format designed to generate a strong and prolonged immune response.

Carlene

Carlene ...

Thank you for finding the number so others can look at theCVAC trial as well!
I think I confused you ...sorry...initially I was responding to softD who had posted she was on the CVAC trial and I was excited to find another person doing the trial. It got mixed up in the discussion of the Survivin trial. You are right there are so many trials and many look promising ...surely one will be the answer ...they seem so close to finding the cure.
Good luck with your surgery...I know it is hot in Texas...I have a good friend there.....a good time to be in the air conditioning and getting well! Hugs!

Linda

Hissy_Fitz

antcat said:

Hi Carlene, saw your latest info and yes you're right I talked to the oncologist today and he told me that the trial is for people in remission. But, I advised him that the way I read it it's for people who are not in remission but have the disease. I'm going to see my gyn/onc in a month and I'm going to ask him about this. There is nothing listed yet about the inclusion/exclusion criteria so I'm going to keep looking.

P.S. Again, good luck with your hernia surgery on Tuesday 8/9. And, also I went for my 3rd cycle of chemo today (taxotere only) and they did a CA 125 test. My figure went up a point. I know it's probably not bad but still people worry. I think the oncologist told me last time that it takes about 2 cycles for the CA 125 to normalize, But mine is up to 10 now. Anyway, hope to hear from you after your surgery.

Thanks again for telling about this new trial. You are absolutely wonderful in sharing information with us.

Antcat....
Vaccines are
Antcat....

Vaccines are usually tested on patients in remission because a vaccine isn't really a treatment, it's a preventative. The idea is to prevent the cancer from recurring. Later (much later) a vaccine may be developed that will prevent the first occurrence of OC and women would receive it routinely.

Carlene