Comments on Beta Delta's articles RSS Syndication from SeekingAlpha.com http://seekingalpha.com/author/beta-delta/articles http://seekingalpha.com/article/77515/comments?source=feed#comment-766097 766097 Wed, 18 Nov 2009 17:02:12 -0500 Please, DNA's moving ahead because if they dont there flagship drug will have competitors when their herceptin patents eclipse. If they take care of business now they can control the market later, lets just hope they dont buy IMGN]]> http://seekingalpha.com/article/60655/comments?source=feed#comment-516822 516822 Mon, 25 May 2009 12:10:24 -0400
The first fact is that far more then 1/3rd the deaths in the 92 events occurred in the group receiving the SOC alone, which is 1/3rd of the patient population. The second fact is that far more than twice as many resections occurred for the 2/3rd of the patients on TNFerade.

We'll also see the actual K-M Curves for the first time, but I believe discussion already released gave people a reasonable idea of what they should look like.

There is no doubt, the company is cash starved and it's holding down the price. I believe on seeing the full results investors will arrive at the conclusion that the drugs performance leaves no doubt it will be approved, and it will confirm in many peoples mind that a partnership will occur when the company's satisfied with what's offered.

No one likes seeing a company with inadequate funding, but the question is, do you invest now, while the stock's 70 cents, after ASCO when the data moves it into the $1 to $5 range, after a partnership when the range moves from $4 to $10 or more, or after approval when $15 to $30 could easily be justified.

If you look at the mechanism by which TNFerade works, you'll find that pancreatic cancer's just the tip of the iceberg. Benefits are already significant in trials on Head and Neck and Esophageal Cancers, but there's little doubt it can be applied to many others, perhaps most cancers. Unlike other drugs, it will compliment most other drugs rather than competing with them.

If you look even deeper into the company, you'll find that in addition to TNFerade, GNVC has Foot and Mouth Vaccines that Homeland Security has developed with them and H.S. is committed to a large buy of one or more of the vaccines late this year. This can be found in H.S. documents, not GNVC claims. GNVC has not yet even claimed a soul source contract with H.S. that's been announced, but apparently not yet awarded. I mention this because FMD Vaccines may very well answer the immediate cash problems faced by the company.

Gary]]> http://seekingalpha.com/article/113408/comments?source=feed#comment-365852 365852 I have to disagree with the previous comment. Your article was not > clear to me. > > After plodding through the statistics (and admittedly giving up in > frustration) from what I gather, your article confirms what is already > clear and it is that the American pharmaceutical industry is completely > bankrupt and even immoral in its search for a cure for cancer.
> > Avastin, the other 'blockbuster' drug from Genentech, costs about > $100,000 only to prolong the lives of advanced colon cancer patients > by about two months. > > Cancer cure rates have remained almost flat for over twenty years. > > > The profit motive doesn't seem to work well in science. > > Einstein wasn't interested in physics for the money. > > If Einstein had profited from his discoveries, he and his descendants > would have become the richest people in the world (and possibly controlled > the entire world.) > > My guess is that the drug discovery model will change in the near > future and that pharmaceutical companies will fall on, at least compared > with the past, hard times. > > Just a hunch, of course.]]> Sun, 25 Jan 2009 16:02:56 -0500
www.fda.gov/bbs/topics...

don't know where you got 2 months in colorectal. i think you maybe thinking of lung cancer:
"The median overall survival time for patients in the Avastin plus carboplatin and paclitaxel arm was 12.3 months versus 10.3 months for patients receiving only carboplatin and paclitaxel. "

www.fda.gov/bbs/topics...

and on cost, i think you're using the cost for lung cancer (and maybe breast too) but i think the cost for colorectal is 40k/yr.

On Jan 07 01:04 AM carey_jim wrote:

> I have to disagree with the previous comment. Your article was not
> clear to me.
>
> After plodding through the statistics (and admittedly giving up in
> frustration) from what I gather, your article confirms what is already
> clear and it is that the American pharmaceutical industry is completely
> bankrupt and even immoral in its search for a cure for cancer.

>
> Avastin, the other 'blockbuster' drug from Genentech, costs about
> $100,000 only to prolong the lives of advanced colon cancer patients
> by about two months.
>
> Cancer cure rates have remained almost flat for over twenty years.
>
>
> The profit motive doesn't seem to work well in science.
>
> Einstein wasn't interested in physics for the money.
>
> If Einstein had profited from his discoveries, he and his descendants
> would have become the richest people in the world (and possibly controlled
> the entire world.)
>
> My guess is that the drug discovery model will change in the near
> future and that pharmaceutical companies will fall on, at least compared
> with the past, hard times.
>
> Just a hunch, of course.]]> http://seekingalpha.com/article/113408/comments?source=feed#comment-348190 348190 Wed, 07 Jan 2009 01:04:22 -0500
After plodding through the statistics (and admittedly giving up in frustration) from what I gather, your article confirms what is already clear and it is that the American pharmaceutical industry is completely bankrupt and even immoral in its search for a cure for cancer.

Avastin, the other 'blockbuster' drug from Genentech, costs about $100,000 only to prolong the lives of advanced colon cancer patients by about two months.

Cancer cure rates have remained almost flat for over twenty years.

The profit motive doesn't seem to work well in science.

Einstein wasn't interested in physics for the money.

If Einstein had profited from his discoveries, he and his descendants would have become the richest people in the world (and possibly controlled the entire world.)

My guess is that the drug discovery model will change in the near future and that pharmaceutical companies will fall on, at least compared with the past, hard times.

Just a hunch, of course.]]> http://seekingalpha.com/article/113408/comments?source=feed#comment-347811 347811 Tue, 06 Jan 2009 15:58:42 -0500 http://seekingalpha.com/article/77515/comments?source=feed#comment-218787 218787 Wed, 30 Jul 2008 17:57:19 -0400
dna has also announced two other phase 2 trials, both of which could be registrational according to a top dna official, sue hellmond? sp

With parent Roche, already opting in on trastuzumab-dm1 last sept 2007, this drug, barring a major side effect, and so far nothing even close to a major SE has been found, will have enough statistical significance between either of those two trials in the MBC setting to file for approval sometime in 2010. I suspect only that the possible announcement of a pivotal trial or P3 may be the trigger for a milestone payment, and thus genentech may be holding off until later this year. With genentech still on the hook for approx 37 million in future milestones, and about to enter phase 3, the milestone could approach the 10-15 million mark. Even for genentech, this is a significant cash outlay. But rest assured, it will be paid to immunogen, likely sooner than later. ]]> http://seekingalpha.com/article/77515/comments?source=feed#comment-178887 178887 Tue, 03 Jun 2008 23:42:50 -0400 Good points on some things that might be good to dig into.]]> http://seekingalpha.com/article/77515/comments?source=feed#comment-169168 169168 Fri, 16 May 2008 21:52:41 -0400
Add to this the fact that the Clinical Trials database now shows two new Phase II Trials intended to start in July that will greatly expand the potential use of T-DM1 and you can see that DNA with the concurrence of the FDA is looking to rapidly develop this drug.

I've heard it said that a blind man could see this drug is headed for approval, I believe it's not only true, but the FDA themselves might shorten the process as the data's so overwhelming.

I believe all the new trials, as well as perhaps the current trials, could be using Pivotal Material which DNA now has the capability of making, instead of drug supplied by IMGN. The importance of this is DNA cannot gain approval unless the FDA approves its manufacturing capability, this may already have been done.

It's only a matter of time, and I believe this drug will fly through Pivotal Trials once they're started.

Gary]]> http://seekingalpha.com/article/77515/comments?source=feed#comment-168985 168985 Fri, 16 May 2008 14:32:04 -0400
Hope we will get noticed.]]> http://seekingalpha.com/article/68771/comments?source=feed#comment-129088 129088 Wed, 19 Mar 2008 22:04:21 -0400 http://seekingalpha.com/article/60655/comments?source=feed#comment-112371 112371 Wed, 23 Jan 2008 08:23:49 -0500 http://seekingalpha.com/article/60655/comments?source=feed#comment-112330 112330 Tue, 22 Jan 2008 22:48:21 -0500 Genvec's current PACT TRIAL compares
TNFERADE + SOC VS .....SOC only....

The patients exclusions to participate in the SOC and TNFERADE + SOC are the same.. You can quote past statistics for Tarceva, but they are irrelevant for this study. But for my money, Tarceva is not worth the cost with the method of prescribing as of today. Few patients achieve stable disease by the time they are challenged with Tarceva.
Now relating to Genvec's TNFERADE. The current study recently had its endpoint changed per the FDA to OVERALL SURVIVAL, not six months, not one year... OVERALL SURVIVAL. its measured for both the SOC and TNFERADE + SOC. again apples to apples .

All patients in both arms are dealing only with nonresectable patients with stage 1,2,3 tumor burdens. Why not metastatic patients with stage four tumors. Because the survival rates are too low for that patient population and the ability to achieve statistical significance in that patient population would be null. That subset of patients can be tried once approval is gained. Genvec achieves nothing by attempting to cure STAGE 4 patients and attempting to treat them would cause significant financial drain on a company with limited resources.

How can you argue with a look at preliminary data that shows absolute survival at 71% TNF arm vs 28% SOC arm. in comparable patients populations.
Your conclusions lead me to believe you have a financial incentive to see the pact trial fail.]]> http://seekingalpha.com/article/60655/comments?source=feed#comment-111944 111944 70%). Was the enrollment of patients with similar baseline performance scores to continue in a manner consistent with the initial patient population one might expect results similar, but again not comparable, to prior data. Of multiple exploratory analyses conducted on the Tarceva pivotal data, only performance status had a statistically relevant interaction with treatment effect. For example, patients with baseline ECOG PS of 0-1 had median survival of 6.6 months compared to 4.2 months in patients with baseline ECOG PS of 2; this translates into a 57% relative survival advantage. Based on these facts, the hazards of comparing the reported uncontrolled GenVec TNFerade data with historical data is manifest. In the 50-patient dose escalation study of TNFerade GenVec reported dose-dependent improvements in the ability to surgically resect previously unresectable disease. At the maximum tolerated dose GenVec reported successful resection in 45% of patients. These figures are superficially impressive relative to historical data. In a study conducted at the New England Deaconess Hospital, 16 patients who had locally advanced, unresectable pancreatic cancer were treated with EBRT and infusional 5-FU to enhance respectability. Two (13%) of the 16 patients were able to undergo resection. A study at Duke University reported that two (8%) of 25 patients with locally advanced pancreatic cancer treated with EBRT and 5-FU were able to undergo complete resection with negative margins. In addition, some studies gemcitabine in combination with radiation have demonstrated adequate down-staging to allow for complete resection. Nonetheless, both the GenVec data and data from other studies need to be interpreted with caution. Over time, the very definition of locally advanced pancreatic cancer has been relaxed making the ability to compare results difficult and the ability to see positive results in this regard when no difference is just as likely. ]]> Mon, 21 Jan 2008 14:16:28 -0500
Currently, gemcitabine (Gemzar) and erlotinib (Tarceva) are the only FDA-approved treatments for pancreatic cancer. Gemzar was approved in 1996 on the basis of a pivotal study comparing treatment to 5Fu, which was standard of care at the time of approval of Tarceva. Median survival in the pivotal trial was 5.7 months and 1-year survival was 18% in the study arm (compared to 4.4 months and 2%). In 2005, Tarceva was approved on the basis of a 6.37 month median survival and 24% one-year survival. Prior to the approval of Tarceva no drug, including gemcitabine, had been demonstrated to positively affect survival. Between 1996 and 2005 ten phase II studies comparing new drugs to Gemzar and two phase III studies failed to show any significant survival advantage. In addition, eight phase III trials were conducted comparing new drugs+gemcitabine to gemcitabine alone and all failed to demonstrate a survival advantage. Pancreatic cancer continues to be among the most lethal and difficult to treat cancers.
GenVec has previously conducted two phase I studies of TNFerade (a total of 50 patients) in various locally advanced solid tumors and soft tissue sarcoma of the extremities. More recently, the company conducted a dose-escalation study in 50 patients with unresectable locally advanced pancreatic cancer with four dose levels of TNFerade studied in combination with standard chemoradiation. This study was followed by a 74-patient randomized trial that was subsequently amended in March 2006 to become what GenVec expects to be a single pivotal phase II/III (the “PACT” trial). Target enrollment in the trial is 330 patients of which 75 are estimated to have enrolled to date. Patients with locally advanced unresectable pancreatic cancer will be treated with either TNFerade + standard of care or standard of care alone. Standard of care will include radiation therapy, 5Fu, and maintenance therapy with Gemzar or Tarceva. The primary endpoint of the “PACT” trial is 12-month survival with an expected 20% survival advantage over standard of care.
On December 14, 2006 GenVec announced that a DSMB recommended continuation of the phase II trial after an interim safety analysis. Data was available for 40 patients, 25 of which had received TNFerade. Only 5 days later the company issued a press release highlighting “updated” efficacy results from the trial pursuant to an “initial interim efficacy analysis”. The imminence of this analysis was not mentioned in the press release five days earlier and the press release does not indicate the nature of the analysis as it relates to the protocol. However, a preplanned interim survival analysis on 15% of the targeted enrollment is unlikely and while the company’s press release refers to confidence intervals there is no reference to significance. Moreover, the data released in that press release is inconsistent with previously described plans. A year earlier the investigators indicated that an “interim analysis of the objective response rates at three months after therapy will be carried out on the first 51 patients.” In any event, the fresh data from the December 19, 2006 press release included an analysis of the first 51 patients enrolled in the trial. In this case, data was available for 33 patients treated with TNFerade.

In any event, one-year survival was reported as 71% in the treatment arm versus 28% in the standard of care group. In comparison, Tarceva was approved based on a 24% response rate (Tarceva + Gemzar) vs. 19% with Gemzar alone. However, although the TNFerade figures have been compared to Tarceva and Gemzar data by some, they are entirely incomparable. The pivotal Tarceva trial enrolled all-comers, including patients with locally advanced unresectable and metastatic disease; pre-specified covariates in the statistical analysis plan included performance status, extent of disease and pain intensity reflective of the prognostic significance of these variables.

In the Tarceva pivotal trial, 60% of patients had metastatic disease. Exploratory analyses demonstrated that median survival of patients with locally advanced disease was almost double that of patients with metastatic disease (8.2 months compared to 4.2 months). It should be no surprise, therefore, that GenVec’s data, all based on the treatment of patients without metastases, and are compelling on the surface. In fact, prior progression free survival data presented by GenVec excluded patients enrolled in the trial with metastatic disease at baseline as well as one or more patients who died for reasons deemed not relevant to the analysis by investigators and/or GenVec. More interestingly, this same prior data defined progression free survival based on injected tumor (not patient) response. Disease progression, in other words, was a function of response of the injected tumor and not the patient. One must also ask whether progression free survival at 6 months is a relevant endpoint.

Similarly, median survival in the investigational arm of the study supporting approval of Gemzar in pancreatic cancer in 1996 showed median survival of 5.7 months and 1-year survival of 18%. A study reported in the Journal of Clinical Oncology in 2005 comparing gemcitabine+oxiliplatin vs. gemcitabine alone showed a 7.1 month, or a 24% difference compared to 5.7 months. However, 70% of patients in the gemcitabine arm had metastatic disease. These patients had median survival of 6.7 in the gemcitabine arm vs. 10.3 months in patients with locally advanced disease. The list goes on, however. A phase III study or irinotecan+gemcitabine vs. gemcitabine reported in the JCO in 2004 demonstrated an almost 7-fold higher response rate in patients with locally advanced disease compared to those with metastatic disease. While the survival difference between the two groups was not as large, median survival in the combination arm was almost twice as long when comparing local vs. metastatic patients (9.8 months vs. 5.4 months) and in the monotherapy arm (11.7 months vs. 5.9 months).
In addition, preliminary data from the TNFerade trial indicates that mean Karnofsky Performance Status (KPS) in the 4 x 1011 dose cohort was 85% (the dose being studied in the ongoing pivotal trial), which is likewise not comparable to the demographic profile in the Tarceva trial. In the Tarceva pivotal trial, 17% of patients had ECOG performance status at baseline of 2, which is a significant negative prognostic factor. In June 2006, GenVec reported mean KPS of patients enrolled to date in the TNFerade arm of 89% (inclusion criteria allow for patients with KPS of >70%). Was the enrollment of patients with similar baseline performance scores to continue in a manner consistent with the initial patient population one might expect results similar, but again not comparable, to prior data. Of multiple exploratory analyses conducted on the Tarceva pivotal data, only performance status had a statistically relevant interaction with treatment effect. For example, patients with baseline ECOG PS of 0-1 had median survival of 6.6 months compared to 4.2 months in patients with baseline ECOG PS of 2; this translates into a 57% relative survival advantage.
Based on these facts, the hazards of comparing the reported uncontrolled GenVec TNFerade data with historical data is manifest.

In the 50-patient dose escalation study of TNFerade GenVec reported dose-dependent improvements in the ability to surgically resect previously unresectable disease. At the maximum tolerated dose GenVec reported successful resection in 45% of patients. These figures are superficially impressive relative to historical data. In a study conducted at the New England Deaconess Hospital, 16 patients who had locally advanced, unresectable pancreatic cancer were treated with EBRT and infusional 5-FU to enhance respectability. Two (13%) of the 16 patients were able to undergo resection. A study at Duke University reported that two (8%) of 25 patients with locally advanced pancreatic cancer treated with EBRT and 5-FU were able to undergo complete resection with negative margins. In addition, some studies gemcitabine in combination with radiation have demonstrated adequate down-staging to allow for complete resection. Nonetheless, both the GenVec data and data from other studies need to be interpreted with caution. Over time, the very definition of locally advanced pancreatic cancer has been relaxed making the ability to compare results difficult and the ability to see positive results in this regard when no difference is just as likely.
]]>