Bill is giving us sensitive information that Hawkins would not offer. On
the other hand. I think some of you forgot that cachexia in any patient
is cachexia regardless of the disease. Therefore, a study on cachexia
may be acceptable to any forum that is focused on a certain disease. Sad
to see Bill blabbing information that has not been publicly disseminated
the ASCO presentation will most definitely not talk about the Weizmann
rats. For one thing, the conference is meant to present findings on
clinical studies in human cancers. For another, Irun Cohen's lab was
working on the anti-inflamamtory effects of AVR118, and not in cancer
models. There has not been a peep out of ADVR as to any new Weizmann
results, which leads me to wonder if studies there have been halted.
decision of Dr. Hawkins not to pursue the existing topical IND may have
put the company back to square one,to where it was three years ago. An
IND in the hand may well have been worth two in the bush. I thought the
original intent was to get the drug to market in whatever form, so that
physicians could start using it, and then go on to other formulations.
The topical formulation was deemed to be the easiest to get through the
FDA and into the marketplace. But the succesful topical IND now
languishes unused three years after it was approved by the FDA. The
topical IND need not just be used for HPV-induced genital warts but
would cover any other topical uses of the drug as well, and we have been
told there are potentailly many.
The FDA rules for an injectable drug are much more stringent
than for a topically applied drug. They need to see much more science to back up claims relating to the drug's safety, absorption into the body, distribution in the body's tissues and on elimination of the drug from the body. After the company's drastic layoffs of scientific staff at the end of 2002, I doubt that all this necessary science has been accomplished. I fear the FDA may very well send ADVR back to the drawing board when the injectable drug IND application is presented in two or three months, and require them to come back with more data. This could delay things even more. I just hope that Dr. Hawkins has studied the issue well and is making a very informed decision based on all available data. Even in the best case scenario, a fast-tracked application would take about three years to complete; that would be six years after an IND was issued for the drug by the FDA.
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They'll probably present the data on the completed AIDS cachexia
patients in Israel and hope to extrapolate those results as the drug
also having potential in cancer cachexia patients (since from the
standpoint of cytokine release there are similarities between cancer
cachexia and AIDS cachexia). That would potentially get the experts in
cancer cachexia and palliative care attending the ASCO conference
excited about the prospects of AVR118, and may help develop future
physician contacts to do cancer cachexia trials in the U.S. I believe
this is ADVR's game plan.
Patients Dosed with CoFactor(TM) in U.S. Phase II Clinical Trial for
Metastatic Colorectal Cancer
Tuesday May 4, 10:00 am ET
SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX - News) announced today that it has started dosing patients in a first line Phase II clinical trial to test CoFactor in metastatic colorectal cancer. CoFactor, a biomodulator of 5-fluorouracil (5-FU), one of the most widely used chemotherapeutic agents, will be evaluated in patients not previously treated or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor qualifies for the FDA's Fast Track Program for rapid drug review for metastatic colorectal cancer. In addition to the VA San Diego Healthcare System, the trial is taking place at several other sites in the U.S, including Mercy General Hospital in Sacramento, California, where the first patients were dosed.
"We are very pleased to begin testing of CoFactor in the U.S.," commented Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX Pharmaceuticals. "This is the first stage in our expansion of clinical testing of CoFactor for treatment of a variety of cancers, with an emphasis on lower toxicities and increased survival compared to current therapies. Later this quarter, we also intend to file for clearance to begin first-line metastatic colorectal cancer trials in the UK as part of our international strategy for regulatory approvals."
CoFactor (5,10-methylenetetrahydrofolate) is a chemotherapy drug designed for use with 5-FU. CoFactor is a form of folic acid which acts by enhancing the anti-tumor effects of 5-FU while reducing side effects compared to current therapies. Unlike leucovorin, the currently used adjunctive agent, which has to be metabolized in the body to be effective, CoFactor bypasses the biochemical pathway to deliver the correct form of folate to cancer cells allowing 5-FU to work more effectively. CoFactor was previously studied in Phase II trials in Europe which showed a 100 mg dose of CoFactor given 20 minutes before IV administration of the chemotherapy agent 5-FU was able to improve survival in metastatic colorectal cancer patients and showed very low toxicity.
"Delivering folate in this form may allow 5-FU to work more efficiently to abate tumor growth. This appears to be the case from the data from previous European studies," remarked Tony Reid, M.D., Ph.D., the study's Principal Investigator of the VA San Diego Healthcare System. "We certainly hope similar results can be achieved here in the U.S."
According to the American Cancer Society, colorectal cancer is the third most common cancer both in men and women and is the second leading cause of cancer death in the U.S.
if in fact the real reason was that the data did not support the HPV
hypothesis, then how responsible/liable is ADVR for reporting otherwise
in their SEC filings.
All we've ever wanted - as shareholders - was the truth and in a timely manner.
Your supposition, if true, would be a HUGE breach of faith on the part of the company.
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Yes, sounds reasonable. Also, I was wondering since ADVR gave a poster
presentation at 1st ISC International Conference on Cancer Therapeutics
- Molecular Targets, Pharmacology and Clinical Applications, held in
Florence, Italy, is there any reason why they wouldn't repeat this at
"As a consultant and member of the Scientific Advisory Board of ADVR, Dr. D'Olimpio is involved in laboratory, translational and clinical research in the field of drug treatment of cancer and has been invited to present a poster and prepare an oral presentation at the conference. D'Olimpio's abstract is entitled "Use of a Peptide Nucleic Acid Complex in Cancer Regulation and Metastasis: A Preliminary Report of Bimodal Effects In Vitro" and is on the basic scientific aspects of what has been discovered during active "bench research" on AVR 118. Findings show that there appears to be specific areas that can impact on a cancer cells ability to "change" into a more normal cell or in the case of tumor cell invasion, hinder the cancer cells ability to spread.
"It is a great honor to present at this conference and it is truly a culmination of the in-depth laboratory work that is being done at ADVR to help explain emerging data in clinical trials," said Dr. D'Olimpio. "We are excited about this possibility as this conference is the perfect venue for this kind of preliminary work. It is provocative and deserves further study."
Thanks for your thoughts presented here.
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the company line is that they felt the money would be better spent on 3
trials in Israel 2 of which they dropped. Recently the company said they
were considering reopening the HPV trial. Now they are not sure what
they want to pursue AGAIN and Elma reportedly points to a triangle that
has AIDS cancer and RA on it. I think it is high time they caught the
freaking tiger by the toe and picked something and went with it.
Huge breach of faith- yea- I would go so far as to say that IMO.
If the drug doesn't work topically on genital warts as you say, then the
data in ADVR's patent "Method for treating Papillomavirus
Infections", US Patent 6,670,118 dated December 30, 2003, are
probably wrong or invalid (we have no idea from what patient studies-
(Argentine?) these results originated) . Example 1 cited in this patent
says that 5 patients were treated topically, twice a day, for two weeks
and the lesions disappeared completely in all of them. Example 2 says
that of eight patients treated topically once daily for four weeks,
lesions completely disappeared in seven patients. If these results are
to be believed, the drug is spectacular in treating genital warts in
both males and females, and being non-toxic and non-irritant would be
considerably more advantageous than current drugs on the market. There
would be absolutely no logical reason to drop the topical IND for HPV,
unless the company had second thoughts about the validity of the data
presented in this patent.
Of course, the other patents that ADVR owns also claim some "miraculous" cures. The patent on basal cell carcinoma (whose inventor is none other than Bill Bregman!)
states that the drug causes the resolution of basal cell carcinoma when applied to the lesions. If this were true and the results were replicated, AVR118 would have been a blockbuster drug on the market for this use and would have found worldwide acclaim. The claim in yet another patent that the drug stimulates red blood cell production also remains to be verified. Contents of patent applcations are not subject to the exacting peer review standards of scientific journals and the claims, though exciting, may leave much to be desired. Unless they are verified by controlled clinical trials, the therapeutic examples cited in the patents are largely useless as far as a drug's regulatory approval goes.
here have probably already seen this. Well, now you get to see it again.
Advanced Viral Research Corporation Waits for Results of AVR118's Cacehxia Trial
By Chael Needle
Advanced Viral Research Corporation (ADVR) has released a forward-looking preliminary sketch of forthcoming results of a clinical trial in Israel studying the safety of AVR118 (formerly called Product R), an immunomodulator, in its treatment of body wasting. The results have not been published yet and cannot be reviewed, but ADVR decided to send out a press release claiming that the first fifteen patients in the study, all of whom were experiencing body wasting as well as failing HAART regimens, showed improvement in appetite, weight gain or stability, and enhanced quality of life; none reported significant side effects. Readers should note the smallness of the sample—not because it’s unusual for a Phase I trial, but because it’s too early to tell if these results can be replicated and if the other fifteen patients that will complete the results will make good on the theorized safety and efficacy. The only FDA-approved treatment for body wasting in individuals with HIV/AIDS so far is the recombinant human growth hormone, somatropin.
I had interviewed Dr. Shalom Z. Hirschman, then-President and CEO of ADVR, in November 2002 for this column. At the time, Dr. Hirschman was excited about the Israeli studies, which would look at the immunomodulator as a possible salvage therapy for patients failing HAART, as well as a treatment that could reverse body wasting and mitigate the toxicities of HAART drugs. I was expecting to hear results about AVR118 as a salvage-therapy candidate. As it turns out, the only results offered so far concern body wasting. An important quality-of-life issue, to be sure, but the absence of news about other trial goals is disappointing.
“When we looked the raw data that was published—or, rather, put out into the press release—what we found was that virtually every patient had a response. In other words, all patients had a response, “ says Dr. James D’Olimpio, M.D., Director of the North Shore University Hospital’s Supportive Oncology and Palliative Care Service in Manhasset New York, and a member of ADVR’s Scientific Advisory Board as well the company’s spokesperson. “All fifteen patients responded in the kind of parameters [one needs] to publish with. I can’t get into that right now because the database isn’t complete.” Though he is not participating as a researcher in the trial, he has treated body wasting in patients with cancer as well as those with HIV/AIDS since the mid-eighties and has researched body wasting for the past five years. He sees this trial as part of new scientific attention being devoted to understanding body wasting. Any drug that is eventually developed, however, won’t be a “magic bullet, or monotherapy. It’s going to be a number of things. We’re building pieces of the puzzle,” he says. “AVR118 could be something we can use to reverse the process of body wasting.”
Dr. D’Olimpio has found that treating body wasting, or cachexia, in patients with cancer dovetails with patients with HIV disease. Body wasting is caused by different things in each but they do have similar models in the sense that “both have a number of different inflammatory pathways that become activated” in common. Says Dr. D’Olimpio: “The key feature in both situations is that skeletal muscle, what’s called lean body mass, is significantly affected. Once skeletal muscle is affected, then the body cannot fight it off from the standpoint of immune response or from the standpoint of being able to tolerate therapy.” The organs cannot support themselves as a result and eventually deteriorate, he says, as evidenced by the “20,000 individuals who ultimately die of HIV disease each year who lose weight as the key feature of why they get infections or why infections lead to weight loss.” He continues: “The weight loss itself is a reflection of this inflammatory process by which patients cannot muster an effective response and/or tolerate their treatments.”
One present goal for treatment research in general is to find drugs that down-regulate or interrupt these pathways. The targets are the signals that tell the body to siphon off protein from muscle and, in effect, keep aberrant inflammatory processes going. EPA, a fatty acid, and amino acids have been found to dampen signals, according to D’Olimpio. “It also seems that AVR118 does this. The information coming out is worthy of scientific publication.” At this point, however, all we can do is wait and see if a new treatment for body wasting is indeed on the way.
Chael Needle reported on cardiovascular disease and HIV for the December 2003 issue.
drug causes the resolution of basal cell carcinoma when applied to the
lesions. If this were true and the results were replicated, AVR118 would
have been a blockbuster drug on the market for this use and would have
found worldwide acclaim."
I can tell you, personally, having a series of basal cell carcinomas on my forehead and having used Reticulose (applied topically and injected into the lesions) - that in the end I had to have surgery and finally some low level electron beam radiation treatment for the lesions. When I had applied it to begin with, it seemed as if the lesion was getting better - but subsequently, it simply remained and got worse.
For at least THIS positive anecdotal report, my anecdote refutes that one.
Also, I have taken Reticulose injectable when I was coming down with the flu, with no response. This does not mean others DID have results positive - but reveals the inadequacy of anecdotal reporting, upon which much if not all of AVR118's success is based.
I agree with you, do the HPV, starting with the already granted approval to move into Phase II testing.
And do it NOW!!
was I thinking the "C" in ASCO stood for Cancer!!!"
Mostly because the ASCO stands for American Society of Clinical Oncology - which basically means the same - it IS a cancer conference, for reports on clinical rather than laboratory findings.
Don't let anyone fool you into thinking this is NOT a conference about cancer. The wasting process is of course part of cancer, and I'm sure the presentation WILL be about connecting the wasting in HIV to cancer wasting - and AVR118's effects on that.
the good doctor this years ago when i spoke to him, get the easier one
passed the fda, then the other ones will fall into place, meaning start
with the topical, then move on to the injectable, get your so called
foot in the door first
Keven, I see we got 12 mil from Dicke, China patent, preliminary results
from Israel and several other tid bits over the past year. Yet, I feel
as though I am picking up right where I left off. Nothing much to make
me feel comfortable with my investment. Just keeps draging on year after
year. We need something to give us credibility. I expected to be farther
along with the trials and credibility would take its natural course,
with good results. I expected a long wait but, this is way too long.
Could it be that this company is being run by a bunch of money waisting
incompatents, I just can't get over the fact that I am sitting here
looking at the same thing.
I'm done venting.
Nice to here from you too, Dan
firm Amgen interested in Israel
Haaretz, May 04, 2004 Iyar 13, 5764 Israel Time: 01:44 (GMT+3)
By Ora Coren
The world's largest biotechnology company Amgen is looking into cooperation with Israeli biotech companies. The company with a $74 billion market cap recently reviewed fifty Israeli projects and opted to look closely at ten of them.
"It will be a few months before we decide, but I hope to find two or three companies we can invest in," Amgen vice president for manufacturing, Efi Cohen Arazi told Haaretz's TheMarker magazine in an interview. The full text of the interview will be published in Hebrew next week.
Cohen Arazi said Amgen had decided to increase its resources in global cooperation fourfold. Amgen is seeking companies the world over whose products are in Phase I and Phase II clinical trials.
"Israel has excellent research and development infrastructure, and the country is one of the top five in Europe and the top ten in the world in research. There is no reason Israel should not attract biotech investment on the scale Switzerland and Sweden do.
"The stock market crash left companies with little breathing room. Two years have gone by and the money has dried up. But an investor can distribute $15 million among five to ten Israeli companies and get much higher value and greater chances of success than investing in a single U.S. company."
Cohen Arazi, a graduate of Hebrew University's College of Agriculture, moved on to a job at Israel's Weizmann Institute and then to major international players in the biotech field. Arazi said Israeli biotech suffers from a management void and that not all Israeli biotech managers lead their companies according to regulatory requirements like those of the American FDA.
Eyes Safety of Popular Anemia Drugs
Chemo-Related Drugs May Spur Early Death in Cancer Patients and Others
May 4, 2004 -- Two popular anemia drugs are under scrutiny by an FDA advisory panel because of ongoing concern that the medications may lead to early death in some patients with cancer and other diseases.
Experts met with drug makers and FDA officials in an effort to monitor several studies involving the drug erythropoietin (EPO). The drug, which raises red blood cell counts, is popular with cancer patients who develop anemia, or low red blood cells, during chemotherapy. Many doctors favor the drugs because they can help combat the fatigue associated with anemia while avoiding the need for blood transfusions.
Meanwhile, makers of Procrit and Aranesp, two EPO drugs available in the U.S., defended their products as relatively safe and suggested that the drugs may even extend patients' lives. They pledged to move quickly on several ongoing clinical studies aimed at answering lingering safety questions.
"We have these evolving safety concerns. They cannot be dismissed," says Harvey Luksenburg, MD, a medical officer in the FDA's division of therapeutic biological oncology products.
Experts are most concerned about a handful of large European studies showing that EPO drugs may cause cardiovascular problems or even worsening cancers in patients on chemotherapy.
One study performed on 940 women on chemotherapy for breast cancer showed a 2.3% rate of fatal blood clots or other fatal cardiovascular events in women taking Eprex, an EPO drug available in Europe but not in the U.S. Women taking placebo pills had a 0.4% rate of the fatal events, nearly six times lower. The study was planned to last a year but was stopped after just four months because of the safety problems.
In another European study in 2003, cancer patients taking the EPO drug NeoRocormon had an 11% rate of dangerous cardiovascular events such as stroke, hemorrhage, or blood clots, while those on placebo had a 5% rate.
Results from that study also showed that patients on placebo were less likely to see their cancers progress, suggesting that EPO could be having a cancer-promoting effect.
Other studies showed no risk of dangerous heart problems with the drug and no signs that the drugs promote cancer. Overall FDA reviewers found four studies showing a higher risk of heart problems with EPO and three showing no increased risk.
Drug manufacturers defend their products, noting that large scale trials conducted in Europe show that EPO drugs have no impact on the overall survival rates of patients with lung cancer, lymphatic cancer, and other malignancies. While many studies have indicated an increased risk of blood clots in patients taking EPO, patients' overall life spans were not affected, says David Parkinson, MD, vice president for oncology clinical development for Amgen, Inc. The company makes the EPO drug Aranesp.
"We believe that our detailed examination confirms the safety profile of Aranesp," he says.
Parkinson referred to "a significant amount" of preliminary evidence showing that the drug could pose a measurable benefit to anemic patients on chemotherapy.
Both company and government officials agreed that more studies are needed to determine what effect EPO has on patients with different kinds of cancers, and whether or not the drug could actually have an effect directly on cancer cells, possibly causing them to grow.
American Volunteers Needed
Still, regulators and experts remain concerned that most if not all of the large EPO studies were performed in Europe and not the U.S. Officials expressed worry that American patients and their doctors may continue to shy away from signing up for trials where they could be randomized to take EPO or a placebo.
"The real question is, will they be willing to be randomly assigned," says Musa Meyer, a consumer advocate and member of the FDA's advisory panel for oncologic drugs. "I think there are physicians for whom it will be an issue."
Company officials said that several trials testing EPO drugs in patients with lung cancer, breast cancer, lymphoma, and head and neck cancers are continuing to recruit hundreds of patients. But those studies are all continuing in Europe.
"We will have those data very shortly," says Martine George, vice president for hematology and oncology research for Procrit maker Johnson and Johnson. Trials in the U.S. have largely ground to a halt because researchers have had trouble getting patients to sign up.
"We believe the findings should absolutely be applicable to United States practice," Parkinson says of the European research.
SOURCES: Harvey Luksenburg, MD, medical officer, division of therapeutic biological oncology products, FDA. David Parkinson, MD, vice president, oncology clinical development, Amgen, Inc. Musa Meyer, consumer advocate. Martine George, vice president, hematology and oncology research, Johnson and Johnson.
for stimulating red blood cell production United States Patent 5,807,839
Hirschman September 15, 1998
Method for stimulating red blood cell production
The present invention discloses a method for treating anemia by stimulating red blood cells production by administering parenterally Product R, a peptide-nucleic acid preparation.
Inventors: Hirschman; Shalom Z. (Riverdale, NY)
Assignee: Advanced Viral Research Corp. (Hallandale, FL)
Appl. No.: 835797
Filed: April 15, 1997
Current U.S. Class: 514/44; 514/2; 514/21; 514/814
Intern'l Class: A61K 031/395; C07H 021/00
Field of Search: 514/44,2,21,814
looking at a buy in? I have not been watching this company for 16 months
but, it looks like .12 - .15 should be the bottom.
We have Dicky buying in to the tune of 13 million. Shortly after the 12 mil financing, management gets a shake up. My guess is that the financing was contingent upon Dicke choosing new management. Also, results from Israel. I can't imagine that Mr. Dicke financed this with the sole reason being kindness. I can, however, imagine that he fully expects to make a buck or two.
I expect to see a sloooow bump and rise from here on. If you are looking for a big jump, forget it. JMHO after one day of digging.
I don't know of any other Conferences that Advr has plans to attend.
It's always a most pleasant surprise to get a news release regarding our
representation at another Conference from them. I guess we'll just have
to wait and see.
I do give them credit insofar as they are trying to get the word out there in the Scientific Community about AVR118 by presentations at Conferences, and radio, newspaper interviews, etc.
Of course, as we all know, only definitive, substantial successful clinical trial results will be accepted as a reality of what AVR118 can accomplish in improving the outlook and easing the suffering of patients while giving them a more enhanced quality of Life.
a hard time keeping up with all the posts.
Elma vs SZH? No comparison!
Hawkins and Epstein have filed 70 IND's and SZH only one (1).
Hawkins and Epstein have taken 7 drugs to market and SZH has taken zero (0)!
Experience says it all.
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy
Do you know specifically which drugs were brought to market by Elma, and
for which companies?
Of the 70 IND applications put through by Elma and/or Epstein, you say 7 have made it to market. That's a batting average of 10% making it to market thus far. Are the others still in the works or did most fail to make it with the FDA past the initial IND phase. It's one thing to file numerous INDs one after aother; quite another to have successful ones. The proof of the pudding is how many of these filed INDs actually translated into marketed drugs.
you know what the statistical success rate is for a drug to make it to
market??? I bet it is less than 10%.
My point in the post of Hawkins vs SZH is experience and Elma wins hands down!
To make that even simpler .......Hawkins has a much greater shot than SZH to bring AVR118 to market!
I guess I should have said they were involved in the filing process of
70 IND's and involved in the final process of getting 7 NDA's to market
throughout their careers with different companies.
Elma did not say that the 70 IND's spawned only 7 approvals; that is your's and Tele's extrapolation.
Bottom line, shareholders should feel more confident with Hawkins at the helm as opposed to SZH. Wouldn't you agree?
should feel more confident with Hawkins at the helm as opposed to SZH.
Wouldn't you agree?"
What is going to happen to SZH, will there be any repercussions if his contract is not renewed??
And are there any legalities insofar as any scientific materials he "might" think he owns??
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IHMO, SZH is resolved to being a lameduck until the end of the year when
his contract expires. Hopefully, Elma can get any needed scientific info
form him before he's gone. I wouldn't be surprised if SZH withholds info
with the hope that Elma should fail. That fits his character even though
he would benefit from the 39MM options he still has. But, as we know SZH
only wants to help himself and will cut his nose to spite his face if he
isn't the center of attention. Maybe ADVR will keep him on as a