Hi folks, thought I would pass this potentially exciting news along. I've been following this company since I was first diagnosed with SCC base of tongue in January of this year. While this isn't by any means a cure, it gives hope for me at least if this thing ever comes back.

By the way, had my first 3 month checkup yesterday and all things are clear.

Introgen Receives FDA Fast Track Designation for Advexin(R)
Wednesday September 17, 7:01 am ET


AUSTIN, Texas, Sept. 17 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced today that its investigational cancer therapy, Advexin, was granted designation as a Fast Track Drug Product development program by the U.S. Food and Drug Administration (FDA) for its effect on prolonging survival and on prolonging the time to loco-regional disease progression in patients with recurrent, unresectable squamous cell carcinoma of the head and neck. Each year approximately 40,000 Americans are affected with head and neck cancer.



By designating Advexin as a Fast Track product, the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of Advexin. FDA may also evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions. The FDA previously granted Advexin orphan drug status in head and neck cancer.

"We are extremely pleased by today's news since it confirms Advexin's potential to treat a devastating disease for which there is no approved biologic or drug treatment. It also reflects the FDA's leadership in the war on cancer by providing biotechnology and pharmaceutical sponsors with assistance in accelerating the development and approval of essential therapies," said Dr. Max Talbott, Introgen's senior vice president of worldwide commercial development.

Introgen currently has two ongoing phase 3 studies of Advexin in head and neck cancer. In one study the effect on survival time (primary endpoint) of Advexin mono-therapy is compared to that of methotrexate. Secondary endpoints are objective response rate, time to progression and tumor growth control. In the second study, a combination of Advexin with platinum and 5-fluorouracil is compared to that of the combined chemotherapies. The primary endpoint in this study is time to progression. Secondary endpoints include survival time, objective response rate and tumor growth control.

Two Advexin phase 2 studies have been completed in which patients with recurrent head and neck cancer received injections of Advexin at two dose levels into local and regional disease. In these studies, patients receiving a higher dose, consistent with the dose used in Introgen's phase 3 studies, experienced an 88 percent improvement in median survival time compared to historical controls, as well as an increased survival compared to patients receiving the lower dose of Advexin. Additionally, 73 percent of the tumors that were injected with Advexin stopped growing or diminished in size.

Clinical responses were observed in patients whose tumors were resistant to previous chemotherapy. Both phase 2 studies were conducted using Advexin alone, as a mono-therapy. The most common adverse events in both studies were fever without infection, pain on injection, and nausea. There were no significant bone marrow, liver or kidney toxicities observed in patients in either study.

In addition to demonstrating the potential to treat head and neck cancer, Advexin has shown indication of effectiveness in other cancers. Data published in the January 2003 issue of the journal Clinical Cancer Research of a phase 2 study of patients with non-small cell lung cancer treated with Advexin and radiotherapy showed over 60 percent of patients' primary tumors regressed or disappeared after the combination therapy, as assessed by both biopsies and by CT scans three months after treatment. Additionally, Advexin administration did not appear to increase the side effects caused by radiation treatment. Preliminary data from a phase 2 study in patients with locally advanced breast cancer indicated that Advexin can be safely combined with two standard chemotherapies, Taxotere

Sounds promising, Hopefully it will get approval
soon. We need some good news!!

The part "About Head & Neck Cancer" Is a bummer. After initial treatment if there is a reoccurance it is likely the person will be dead within 6 to 12 months. The doctors don't tell you that!!

Hey, Dan, I thought the same thing when I read that, we`re dealing with reoccurance number 4, and we`vr been hanging in for over 5 years now, so don`t always believe statistics! But, this new chemo drug is good news, and we sure need that !!!!

Take it in context guys...that is promotional material from a Pharmacutical company, who are trying to make it sound as dismal as they can in order to show how wonderful and badly needed is their product. Although I really hope that the product works as well as advertised, I will not take to heart their statement of our awful prospects if there is a recurrence.

All in all it is great news,
Danny G.

That is promising!

And a little more light on statistics that we love to HATE along with "weasel" words: The expression "likely to die" is valid at around 49% survival rate. Many of us have heard such numbers. Once again the numbers do not apply to an individual.

This is a promotional press release FROM THE COMPANY THAT IS MANUFACTURING AND PROMOTING THE DRUG AND THEIR PR FIRM. I would appreciate it if in the future, anyone who wishes to have something like this put up on the OCF site send it to me, and I will see that it ends up in the NEWS section of the site where other preliminary reports on drugs in clinical trials appear. It contains PRELIMINARY DATA AND FINDINGS, not conclusive results. It also contains information that is not based on sound fact (death rates of those in recurrence, which I have gone in and edited out of the original posting) designed to influence potential investors in this firm. Given that Dan, do not read too much into what this says about the death rate. I will take down posts like this one in the future. While they contain some useful information, (to investors, not us

I need to know what makes it "unresectable"

I need this answer. In the beginning the specialists gave us the vague picture of surgery being too invasive.

Sorry,
Mandi

Hi Mandi,
The definition of "resectable" in Taber's Cyclopedic Medical Dictionary is (I added the opposite meaning):

(Un)Resectable: (Un)Able to be removed, esp. by surgical means. Usually used in reference to malignant growths that can (not) be removed completely by use of surgery.

In my case they also told me the surgery was "too invasive" (like radiation ISN'T!?) - it was the standard radical neck disection, 14 hr procedure, with pect flap, followed by radiation. They also stated that my odds were just as good with radiation and chemo only (actually a little better based on possibility of infection). They never said it was unresectable.

I am sure that the location, size, metastesis, differentiation, response potential to radiation and/or chemo, invasiveness, classification and type of the tumor are all factors. Post procedure lifestyle is a minor issue.

It's probably part judgement call. I would discuss it with the doctors who made the call to find out what their rationalization and/or practice guidelines were at the time.

When surgery is the customary, or in extreme cases, the only salvage procedure available for a patient, there are many factors which determine if it can actually be done or not. If it is the usual procedure, it may not be done for reasons of tumor location for instance, accessibility can be an issue. It might also not be chosen because the mass of tissues which would have to be resected/removed is just too large, and the structural devastation to the patient is too extreme to consider. They would therefore choose an alternative treatment, say radiation. But in patients who have already had radiation, we are now down to surgery and chemo. In many head and neck, and particularly oral cancers, chemo has not proven to be an effective, definitive treatment to eradicate the disease completely, leaving surgery as an only option. But surgery can only be done if the area to be removed is small enough, and the loss of vital structures nearby are not also destroyed in the process. Usually when a doctor says something is not resectable he means that surgery would not yield the end results that are desired, or that the procedure itself would be too destructive to subject the patient to. Advanced head and neck cancers can fall into this realm. That is why you read so often here that the doctors are using radiation or chemo to reduce the size of the tumor so that it can be surgically dealt with afterwards. I had radiation first then surgery. This is in many cases considered backwards, but the physical damage from a surgical removal was going to be significant, and they did the rad first to get things down to a manageable size. When I had received the maximum dosage of radiation that my spinal column could take, they finally did the neck dissection to clean up the loose ends that were still around.

If a patient finds himself or herself in this situation, with an unresectable mass that has to be dealt with, many times it is best to consider clinical trials of new experimental or trial drugs to bring things under control. This becomes the patient

I should clarify what I meant by "Post procedure lifestyle is a minor issue". I meant what I do for a living (entertainment). The doctors referred to it as a lifestyle. It wasn't the most important aspect for my selection of treatment options, hence the "minor" designation.

Do not confuse this with (poor) lifestyle choices such as drinking, substance abuse, diet abuse or using tobacco products. The data is abundant on the severe risks of these choices. They can add MAJOR risk of recurrence.