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Alcon
In last years survey conducted by Dew in the Yahoo forum, Alcon did not receive one vote out of 49 voters. Has the recent clinical result with Retaane changed the likelihood of Alcon as a possible partner for GENR's Squalamine?
All opinions welcome...
Dew..Thank you for your continued education and informative post. LL&P
4 months of Accumulation?
Dew and others of knowledge...Does this really indicate the stock is being accumulated or not? I have no idea if this really means anything. Any insight would be appreciated.
Regards
Rich
http://stockcharts.com/def/servlet/SC.web?c=genr,uu[h,a]daclniay[pd20,2!c10,50][vc60][iLc20!Lf]&...
Partnership Timeline
Back in May I voted for October-December 2004 for a partnership deal. May I change my vote to 2005?
Overall I view the news today as "good". The modification of the 208 study (IMHO) demonstrates that management is carefully assessing the information as it becomes available.
AMD partnership timing survey
I would be very interested in hearing an explanation why someone would vote that GENR would "Never" get a partnership for Squalamine-AMD.
Randy - congrats on NSTK. Hope your correct regarding GENR.
Regards
"I now think that drug supply is an issue for GENR. There is no other plausible explanation for such a long delay from the FDA’s acceptance of the IND until the commencement of all the phase-2 trials.'
Dew...I think you had it right the first time. It is my belief that GENR management may be delaying this third study with Visudyne until enrollment is completed in the very important monotherapy study.
Last week, a friend of mine here in Milwaukee contacted the PI in Madison WI to determine if he was a qualified candidate for the study. Unfortunately he has the "dry" version of AMD and was told that this study for the “wet” version only. He was told to contact them periodically for other studies. The reason why I mention this is becuase it may confirm that enrollment for this critical "monotherapy" study is not yet complete. Upon completion, we should then see the announcement of the Phase-2 Squalamine study with Visydyne.
Keep the faith.
Regards
Post 3639
What happened to post 3639? I had to get off the computer and did not finish reading the story?
GENR - Phase II Study with Visudyne
Anyone care to speculate when GENR will initiate the last of the Phase II studies? Good luck to all longs!
Dew,
Given the hours and the time of day or night that you post your informative messages, perhaps a nap would suffice.
Biotechinsight Newsletter
The following is from the newsletter Biotechinsight…just another perspective…
One goal in a bad market is to stay with the small caps that offer upside with minimal risk. Last week I wrote about BioMarin (BMRN), which I consider in this category. Some readers have asked about Genaera (GENR), Repligen (RGEN) and Sonus (SNUS). I like all three stocks at these depressed prices but I consider SNUS to have the least risk. GENR will have some Phase II data by the end of the year and a lot will hinge on how that looks. If it mirrors the Phase I results but over a longer time course then I think the company has a winner but there is considerable risk—I am still keeping my position. The same holds true for RGEN. In this case the risk is in how the patent litigation plays out and whether BMS and Imclone negotiate settlements.
Thank you for the clarification regarding the Russell Index. Essentially, I was only questioning any potential influence the Russell Index might have on exposing GENR story.
I have much to learn about investing, but perhaps this forum is not the place to ask my simple questions. Sincerely
Russell 3000 Index
Just curious, do you folks have any insight or opinion regarding the impact of being listed in the Russell 3000 Index? Will this additional exposure of GENR to the Investment community make a real difference in communicating the company's true potential?
Thanks for your time.
Market cap comparison
I find it unbelievable that the market cap of EYET continues to go up and is now 1.79 Billion while GENR remains only (1/10) of EYET at 186 Million.
I am actually feeling sorry for those folks that think they are getting such a great deal purchasing EYET at $44/share.
Thanks again for your opinion regarding GENR's fundamentals. If the information that was presented last week at the Annual Meeting holds true, we have nothing to worry about.
Regards
Any news on MEDI and IL-9 program in the 1Q04 review today? Are thay still on track with Phase 1?
Thanks in advance.
RW
Low-calorie diet may lengthen life
By Rob Stein (washingtonpost.com)
Updated: 12:29 p.m. ET April 20, 2004
A small group of people who are drastically restricting how much they eat in the hope of slowing the aging process have produced the strongest support yet for the tantalizing theory that very low-calorie diets can extend the human lifespan.
The first study of people who voluntarily imposed draconian diets on themselves found that their cholesterol levels, blood pressure and other major risk factors for heart disease -- the biggest killer -- plummeted, along with risk factors for diabetes and possibly other leading causes of death such as cancer and Alzheimer's.
"These people are definitely protected against the major killers," said John O. Holloszy of Washington University School of Medicine in St. Louis, who led the study, released online yesterday. "It should definitely increase longevity."
While it has long been known that eating well and staying trim helps people live healthier lives and avoid dying prematurely, evidence has been accumulating that following extremely low-calorie diets for many years may do something more -- significantly extend longevity beyond current norms.
Lab rats, mice and other creatures live much longer when fed very low-calorie diets, and some researchers suggest the same Fountain of Youth effects may hold true for people, perhaps by cutting the body's production of harmful atoms or molecules known as free radicals. But aside from a few corroborating clues from historical records of famines, the only evidence from humans came in 1991, when eight subjects in the sealed Biosphere laboratory in the Arizona desert unintentionally tested the theory when their food ran short. Their health appeared to improve markedly, according to a number of measures.
The new study found "profound and sustained beneficial effects" in 18 people from the United States and Canada who had been eating very low calorie diets for three to 15 years, the researchers wrote in a paper being published in the April 27 issue of the Proceedings of the National Academy of Sciences. While far from proving the theory, the findings provide the strongest direct evidence yet in people, several experts said.
"It is a very important paper," Roy L. Walford, a professor emeritus at the UCLA School of Medicine and a leading proponent of the theory, said in an e-mail interview. "You may well be able to choose between [caloric restriction] and that double-bypass cardiac surgery you are not looking forward to."
'I'm a very disciplined person'
Several researchers cautioned that it was unclear whether the improvements were directly the result of caloric restriction, or simply caused by losing weight, eating more healthful diets or other beneficial behavior. In addition, the study was not able to assess whether the lower risk factors translate into longer life. Nevertheless, they said, the findings provided important encouragement to continue exploring the theory.
Holloszy and his colleagues conducted the study after stumbling across an online organization of about 1,000 adherents, called the Calorie Restriction Society.
One of the members, Dean Pomerleau, 39, a computer engineer from Gibsonia, Pa., cut his daily caloric intake from about 3,000 calories a day to about 1,900 more than four years ago. Pomerleau eats a highly regimented diet that consists of the same two meals daily of nothing but fruits, vegetables and nuts, with a couple of cups of non-sweetened herb tea for snacks.
"I'm a very disciplined person, and food has never been a critical, driving force in my life. So I've never found it as difficult as many may have," Pomerleau said. "For many it is difficult, especially in the beginning. But what you find is that once you get into it it's not a hardship at all. We actually consider it a preferable way to live."
On its Web site (www.calorierestriction.org), the Calorie Restriction Society offers advice for how to maintain equally low-calorie diets but with considerably more variety, including detailed recipes for fish and chicken dishes, a "Pastafree Veggie Pastalike Dish" and more appetizing items such as "Sherm's Bingeing Brownies," "Dean's Fruit and Veggie Smoothies" and "Sherm's Megamuffins."
"Creating highly nutritious low-calorie meals takes some practice," the site says. "Fortunately some of our members have been practicing for a long time and have published their creations to share with you."
Lower 'bad' cholesterol, lower blood pressure
Overall, Pomerleau and the other study subjects had reduced their intake to between 1,100 and 1,950 calories a day for an average of six years. Holloszy conducted a battery of tests on them and compared the results with the participants' earlier medical records, and with results from a similar group of 18 adults who ate a typical Western diet of between about 1,975 and 3,550 calories a day.
Those on low-calorie diets had much lower levels of "bad" cholesterol, much higher levels of "good" cholesterol, lower levels of triglycerides and very low blood pressure. Tests of their arteries showed they looked more like those of children than middle-age adults.
In addition, their blood sugar levels were very low and their body's response to insulin was extremely high, indicating they were at very low risk for diabetes.
At the same time, they had very low blood levels of a substance known as c-reactive protein (CRP), which is believed to be a marker for inflammation in the body. Many researchers believe low CRP levels are linked to a lower risk for a host of ailments, including heart disease, cancer and Alzheimer's.
"It's very clear from these findings that calorie restriction has a powerful protective effect against diseases associated with aging," Holloszy said. "We don't know how long each individual actually will end up living, but they certainly have a much longer life expectancy on average because they're most likely not going to die from a heart attack, stroke or diabetes."
But at a time when the number of Americans who are overweight and obese is soaring despite intensive public health campaigns to get people not to overeat, the idea that large numbers would be willing or able to go even further is daunting, many experts said. If scientists prove the theory, however, they might be able to develop new drugs that harness the biological mechanisms at work or new, safer appetite suppressants that may help more people eat less, experts said.
"If the drug companies can come up with a safe way to control appetite, which is being aggressively investigated, then in that case these kinds of findings may suddenly have profound public health implications," said Richard Weindruch of the University of Wisconsin Medical School at Madison, who studies caloric restriction.
The National Institutes of Health has launched pilot studies to determine whether it is practical to get healthy middle-age Americans to eat very low-calorie diets.
"If in fact it's shown to have beneficial effects, that might give more incentive to lower caloric intakes," said Evan Hadley, an associate director at the National Institute on Aging. "One of the things we're trying to find out is whether lower caloric intake may do things that exercise doesn't do."
Paul Harvey's radio commercial
This weekend I heard a radio commercial (WGN-720) out of Chicago where Paul Harvey comments about AMD and promotes a nutritional supplement for treatment of AMD, not prevention. I recognize this was a radio ad, not necessarily an endorsement. These ads can be very expensive (the company I work for has hired Mr. Harvey to promote our retail consumer products: approximately $900K).
If I hear the ad again, I will make note the brand name for future reference.
I don’t think the management change per se will necessarily make GENR more attractive to a partner, but the IND filing and the clear commitment to proceed aggressively in AMD will get people’s attention
Do you believe that GENR management feels that they would like to have a partnership deal in place by the Annual meeting in May?
Regards
Pending GENR Deal
All very good points. I am not laboring over the pps; instead as previously indicated, I am only concerned with the passage of time. It's like watching a pot of water attempting to boil. We all hope for the best for GENR, I am just venting my frustration with the lack of announcements.
Perhaps turning off my computer for a month or two would best suit my psyche.
As always, a big thank you for your time and effort.
Pending GENR Deal
As each day passes I become more concerned that GENR's management team is hurting the companies chances for getting Squalamine to market soon than later. The "deal" needed to get the Squalamine product into a Phase III study for the AMD indication appears to be on hold for some reason or another. Is a Phase II trial in the great USA really necessary?
The additional 5 million shares sold at $4.04 also has me a bit concerned. I believe that if a deal was around the corner, this recent round of financing was not necessary (IMHO).
Are any of you feeling this way or am I just too impatient?
My interest is truly long term (> 2 years).
Rich
ImmunoGen to test two cancer drugs without partners
Thursday January 8, 9:20 am ET
(Adds details paragraphs 3, 5-6)
NEW YORK, Jan 8 (Reuters) - ImmunoGen Inc. (NasdaqNM:IMGN - News) said on Thursday it will develop two cancer drugs on its own rather than with partners, moves that will increase its expenses for the fiscal year ending in June 2005.
ImmunoGen said it would test one cancer drug on its own even though it had previously aimed to find a partner, and would move the drug into Phase II testing alone.
A research agreement signed with Franco-German drugmaker Aventis (Paris:AVEP.PA - News) allowed ImmunoGen to take the drug in-house because Aventis will help with the funding of other drugs.
In another partnership, Vernalis Plc (London:VER.L - News) will continue two clinical trials already under way with a second experimental treatment, but ImmunoGen will take over future development of that drug, too.
ImmunoGen uses antibodies, or proteins that fight diseases, that are targeted to tumor cells. In addition to the two drugs discussed on Thursday, two other ImmunoGen molecules have advanced into human testing.
Shares of ImmunoGen were relatively flat at $6.01 in electronic trading before the market opened, compared with a Nasdaq closing price of $6 on Wednesday.
The stock closed yesterday @ $7.00. Perhaps the investment community is in support of IMGN decision.
How much is GENR worth?
Dew,
Excellent informative post! Thank you. The folks on the Yahoo board should be reading and researching the information you and others like DrBio provide instead of creating such a mess on the Yahoo board.
Your time and patience is very much appreciated.
Good investing to you
OT: EXEL News update
Dew,
I noticed your post on the EXEL board. With the announcement listed below, EXEL should start to move toward $10/share. Hope you got in before the announcement this morning.
Regards
Exelixis and Bristol-Myers Squibb Company Extend Oncology Collaboration
http://biz.yahoo.com/prnews/031218/sfth009_1.html
OT: DVT
Dew,
Thanks for the link. This one I missed. I'm not sure any of these meds are "ok" for this condition but will look into it further.
Regards
OT: Deep Vein Thrombosis (DVT)- a need for safe preventitive medication
Here is the link to the common blood disorder that 1 in 20 Americans have, including me. Perhaps some of you may know of a "new" potential product can help people by preventing a DVT. IMHO, a blood thinner such as coumadin is not a safe medication to prevent DVT, only to treat them.
It appears that aspirin does not prevent DVT's, only arterial clots.
Any thoughts?
http://www.fvleiden.org/index.htm
Re: MLNM's Velcade
Interesting point. I can foresee the same type of scenario taking place with Squalamine for AMD. Patients in a Phase II/III study "jumping ship" to eliminate further vision loss.
Time will tell.
MLMN - Cancer Drug Study - Phase 3 Halted
Independent Committee Recommends Early End to Confirmatory Phase III VELCADE Trial Based on Achieving Statistically Significant Improvement in Primary Endpoint
Monday December 15, 5:25 am ET
-- Data available one year early; comparator arm patients offered immediate access to VELCADE --
CAMBRIDGE, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Company, based on the recommendation of an independent data monitoring committee and the notification of regulatory authorities, is halting the control arm in the phase III APEX trial. This allows patients currently receiving dexamethasone the option to immediately crossover to VELCADE(TM) (bortezomib) for Injection therapy. The findings of a pre-specified interim analysis found a statistically significant improvement in time to disease progression -- the primary endpoint of the trial -- in patients receiving VELCADE compared to patients receiving high-dose dexamethasone.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"The findings provide important insight into a broader patient population, including patients who received only one prior therapy unlike those treated in the phase II SUMMIT registration trial," said Robert Tepper, M.D., president, research and development at Millennium. "Data from this trial were previously scheduled to be available in 2005 and this accelerates our timetable by over a year. We plan to share the results from this study at a medical conference in the first half of 2004."
The confirmatory phase III APEX trial included patients with relapsed or refractory multiple myeloma whose disease had progressed after receiving one to three previous therapies. Patients were randomized to receive either VELCADE or high-dose dexamethasone, a recognized standard of care in this setting. The trial has enrolled approximately 670 patients and is being conducted in 95 sites in the United States, Canada and Europe. The trial design included a primary endpoint of time to disease progression and secondary endpoints that included measurements of clinical benefit, safety and survival. Data on these endpoints were also reviewed by the data monitoring committee and were found to support the primary endpoint and the decision to end the comparator arm.
About VELCADE(TM) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma - a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.
VELCADE is being codeveloped by Millennium and Johnson & Johnson Pharmaceutical Research & Development L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. and Ortho Biotech Products L.P. and the Janssen Cilag group of companies will be responsible for commercialization in the EU and rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.
Dew...............
It would be most interesting to see a survey of which "Big Pharma" company would most likely signed a deal with GENR for Squalamine, specifically for AMD. Is this something I could help with?
Again thanks for your vested leadership skills and time.
Regards
6 month follow-up for Squalamine for AMD
Should we be expecting 6-month follow-up results to be announced anytime soon? Thes results if postive could provided additional thrust to push GENR onto everyone radars.
More reading regarding Big Pharma
http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yhoo&siteid=yhoo&dist=yhoo&gui...
The Dance
To all, any idea how long (months) GENR management has been in discussions with potential partners? I am concerned about the delay of getting Squalamine to the AMD market that DEW has pointed out may be as much as 6BUDS
Thanks for your insight. Have a great Thanksgiving!
Dew,
Is it your opinion that GENR in concert with the FDA will submit an SPA for Squalamine for the AMD indication? Does an SPA request only come from the FDA or can GENR request consideration.
My apologies if you already covered this issue.
Thx
Valuation?
If we consider the true value of squalamine for AMD which DEW has already suggested based on EYET, and then consider other indications (cancers) for which squalamine appears to be a good candidate, then add IL-9 opportunities for respiratory indications, how can a companies like Fortis and Caris project a valuation of only $10/share?
My opinion is $42 within 24 months from today! Anyone else care to project a fair market evaluation 24 months from today?
Pfizer, Eyetech drug combats age-related blindness
Saturday November 15, 8:30 am ET
http://biz.yahoo.com/rc/031115/health_blindness_1.html
Dew,
Is it your opinion that this recent announcement by Alcon to initiate the Retanne study could impact (good or bad) current interest in "big pharma" signing a deal with GENR?
BTW ...I share your opinion with respect to Merck and their need to look at companies like GENR if they want to compete with other big drug companies.
Thanks
Hi all. Just touching base with the longs and extend my thanks for your informative posts both here and yahoo. Today I added to my IRA account 12700 shares to hold until hell freezes over.
Last week I started accumulating at $4.14 and $4.20.
Rich