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Biowatch - GTCB
Biowatch - Thank you for sharing your telephone conversation with Mr Newberry of GTCB. This group of individuals (DD, Biowatch, Urche, PGS, Drbio45, Randy, mskatie, walldiver & others) are truly a cool bunch of people that like to share ideas and opinions. I have learned much and wish to express my thanks to all of you. Makes every other BB weak in comparison.
Ok..Now back to regular programing.
Good investing to you all!
b.rgds
Re: More DNDN insider buying
Monkey see, Monkey dew…...Sorry I had to. Anyone have the fortitude to add to their GTCB position? I did not today. I would like to see some stability to the pps before I commit to additional shares.
Good luck to all!
"What kind of manufacturing are you referring to, if you don’t mind my asking?"
Sure, I don't mind. One pharmaceutical facility, Shanhai Modern Pudong Pharmaceutical Co. Ltd, in which my main interest was a product called Alpha Lipoic Acid.
Another facility called Jiaxing Hengjie Bioengineering Co Ltd that makes Chondroitin Sulfate amoung other ingredients and then a company called Suzhou Sanjin Nutrient & Health Products Co Ltd that produces Creatine based ingredients.
Mind you my area of interest related to my current career path is focused in a catagory of human nutritional supplements (ie D-Glucosamine, CoQ10, all vitamins, amino acids, botanical extracts, taurine and enzymes such as Nattokinase). I also sell other ingredients to companies like Eli Lilly and DowAgro Sciences.
As a side note, thanks for the updated link to GTCB current status. Last December I purchase shares at the $1.525 area and recently sold 80% of my holdings at the $1.87-$1.81 range on 2/23/05. I felt that my position was unreasonably unbalanced. Now I am considering the risk/reward of adding to my current position.
b.rgds
RE GTCB
What happened? I leave the states for 8 days and everything goes to hell. Maybe a buying opportunity? Well hope all will settle down and that GTCB gets the Q&A done within a reasonable time frame.
Was in Shanghai China for manufacturing audits. Amazing that 19 M people live in such a small area. All the new construction over there makes NY & Chicago look so small.
b.rgds
Researchers discover cholesterol controls cell signals
http://www.drugresearcher.com/news/news-NG.asp?n=58541-researchers-discover-cholesterol
07/03/2005 - US researchers have discovered that cholesterol plays a key role in anchoring a signalling pathway, which has been linked to cell division and cancer. The findings could identify cholesterol as an unlikely drug target.
Although cholesterol has often been linked with heart disease and an unhealthy lifestyle, its properties as a lipid make it essential for the health of membranes that surround individual cells.
Cholesterol is found in every cell of the body and helps to digest fats, strengthen cell membranes and make hormones. Although cholesterol has many important functions, excess cholesterol can build up on artery walls and cause atherosclerosis leading to heart attack and stroke. Therefore, a great deal of research has gone into finding ways of lowering the body's cholesterol levels.
There is a thriving market for cholesterol-lowering drugs with Schering-Plough and Merck’s Zetia (ezetimibe) as one of the newer entrants in an estimated $20 billion (€15.1 billion)-a-year statin market.
The research, performed by scientists at the UT Southwestern Medical Centre, focuses on regions of the membrane where cholesterol is enriched. These regions, called lipid domains, are more rigid than the rest of the cell membrane because of cholesterol and play a critical role in organising signalling machinery at the cell surface. The correct arrangement of signalling modules in these domains is vital for communication inside the cell and is dependent on proper levels of cholesterol.
While studying how cholesterol moves to the membrane to get to lipid domains, lead researcher, Dr Richard Anderson, and colleagues found that cholesterol could work outside the membrane to regulate a key-signalling pathway that occurs inside the cell.
Through an interaction with a protein called the oxysterol binding protein (OSBP), cholesterol holds together a group of enzymes that deactivates extracellular signal-related kinase (ERK). Overactive ERK is associated with multiple cancers.
When the amount of cholesterol in lipid domains is normal, the OSBP-cholesterol complex keeps the amount of active ERK under control. When cholesterol in the domains gets too low, the complex falls apart, leading to abnormally high levels of active ERK.
Researchers revealed that OSBP has binding sites for both cholesterol and the other proteins in the complex. When cholesterol binds OSBP it changes shape to bind the key enzymes in a way that allows them to work together to control deactivation of ERK. When lipid domain cholesterol gets low, OSBP loses its cholesterol and no longer is able to bind the enzymes that deactivate ERK, keeping it active.
"OSBP appears to work like a cholesterol-regulated scaffolding protein that controls a key signalling pathway," Dr Anderson said "This work shows a new way that lipids can regulate key signalling pathways and raises the possibility that other lipid regulated signalling scaffolds can malfunction in other diseases."
DNDN
In at $5.88
Have a good weekend!
Research inhibits cancer's ability to resist treatments
03/04/2005 - A team of researchers have discovered how a key enzyme involved in repairing DNA is put together and how it works, a development that opens up new drug therapies for making cancer cells more vulnerable to attack.
The discovery is all the more important as current treatments are fast becoming obsolete. The cancer’s ability to repair itself and develop resistance to the drug therapy has become a major headache for the pharmaceutical industry.
While the design of cancer chemotherapy has become increasingly sophisticated, no cancer treatment is 100 per cent effective against cancer. Resistance to treatment with anticancer drugs results from a variety of factors including individual variations in patients and somatic cell genetic differences in tumours, even those from the same tissue of origin.
In the study, the team characterised, in three dimensions, the polynucleotide kinase (PNK), a key enzyme involved in a cell's ability to repair single-strand and double-strand breaks in DNA.
Normally, when a single- or double-strand break occurs, the damaged ends need to be cleaned up before they can be rejoined as an early step in the repair process. PNK is one of the key enzymes required to "polish" the strand break ends. Without it, cells are more sensitive to agents such as ionising radiation or certain drugs that kill cells by damaging their DNA.
DNA, or deoxyribonucleic acid, is a large molecule shaped like a double helix found primarily in the chromosomes of the cell nucleus and contains the genetic information of the cell. Once damaged, cells have developed biochemical responses to repair the damage; when they can't be repaired, cells die if the damage is too toxic. Or, if the damage is not lethal, mutations can occur that lead to cancer.
"This gives us a clearer picture of how the enzyme works and opens up the possibility that we can develop drugs that inhibit cancer's ability to repair itself and resist treatments," says biochemistry professor Mark Glover, the lead author in the paper published in today's issue of Molecular Cell.
The research may give some clues as to why some lung cancer patients stop responding to the drugs Tarceva (erlotinib) and Iressa (gefitinib).
These drugs stop the growth of certain cancers by targeting a signaling molecule vital to the survival of those cancer cells. They are effective in about 10 per cent of patients with non-small cell lung cancer (NSCLC). In this type of cancer, which often occurs in patients with no history of smoking, malignant cells carry mutations in a gene that encodes the epidermal growth factor receptor (EGFR).
Although these targeted therapies are initially effective in this subset of patients, the drugs eventually stop working, and the tumours begin to grow again. This is known as acquired or secondary resistance. This is different from primary resistance, which means that the drugs never work at all.
Melatonin study could 'jump-start' interest in supplement
http://nutraingredients-usa.com/news/ng.asp?id=58448&n=dh61&c=czfxppbknydiqm
3/2/2005 - Scientists carrying out meta analysis of research into the effects of exogenous melatonin have concluded that supplements can help improve sleep quality, decreasing sleep onset latency and increasing sleep efficiency and total sleep duration.
The Massachusetts Institute of Technology (MIT), where the research was carried out, said that the findings could “jump-start interest in the dietary supplement”.
Melatonin is a natural, soporific hormone secreted by the pineal gland during the hours of darkness. Melatonin supplements are widely available in the United States and are reported to induce sleep and ameliorate disturbed sleep patterns – both intrinsic and due to extraneous circumstances such as shift work or jet-lag.
Exogenous melatonin reportedly induces drowsiness and sleep, and may ameliorate sleep disturbances, including the nocturnal awakenings associated with old age.
Professor Richard Wurtman, director of MIT’s Clinical Research Center, led the meta-analysis of 17 peer-reviewed papers on the effects of melatonin with the aim of determining conclusively whether or not melatonin supplementation works.
"A meta-analysis essentially tells 'yes' or 'no' that a treatment does or does not have a significant effect," said Wurtman.
His conclusion was a resounding “yes” – a result which he claims means there should no longer be any controversy about whether melatonin works.
The meta-analysis assessed the difference between the response on placebo and the mean response on melatonin for each of the studies, all of which were placebo-controlled and included objective measurements on at least six adults. It showed that exogenous melatonin significantly reduced sleep onset latency by 4.0 min, increased sleep efficiency by 2.2 percent, and increased total sleep duration by 12.8 min.
Taken individually, the 17 studies produced heterogeneous data, which Wurtman suggests were due to differences in doses, quality, excipients and purity of the supplements used.
The data have contributed to widespread skepticism over melatonin’s efficacy, coupled with the risk of serious side effects, including hypothermia, associated with taking too much of the hormone.
Most commercially available supplements contain doses of around 3mg, which is, according to Wurtman, ten times the effective amount.
In a study published in the Journal of Clinical Endocrinology and Metabolism in October 2001, Wurtman and colleagues showed that only around 0.3mg of melatonin is needed to help adults fall asleep and return to sleep after waking up during the night.
He maintains that a higher dose taken over several days can actually block the beneficial effects, as the brain’s melatonin receptors become unresponsive when exposed to excess quantities, and cause some people to experience hangover-like symptoms during the day.
Following the 2001 study, Wurtman patented the use of melatonin in doses up to 1mg and has since licensed the work to Nature’s Bounty for its 1mg supplement.
GENR
Has the recent presentation (last week) by GENR changed any opinions about the company's future in the AMD arena? And is there still a "concern" about the safety profile of systemic drugs for this application?
TIA
GTCB
I missed all the excitement yesterday but very much appreciate the information and opinions as it relates to GTCB.
Dew, you are correct in that I was "hopeful" that we would hear some news from Dr Cox, not related to ATryn®, but hopes of an update on the "unnamed" new-product partner which was expected to be revealed late in 2004.
I have not yet heard the CC, but after reading your posts, I am very impressed with the exceptional achievements in the US trial design. I am also very encouraged with GTCB abilities to communicate with the FDA resulting in this type of advancement in the US environment. Absolutely outstanding!
IMHO, at this low PPS, I plan on adding to my core.
In the future I will abstain from predicting news announcements in the future. :)
Thanks for all your hard work!
IMHO, at this low PPS, I plan on adding to my core.
b.rdgs
GENR - Comments by Mark Z
This was from a recent post from the GENR Yahoo message board addressing questions from Bladerunner on the subject of combination therapy.
I have not seen any of the current presentations, only the press release. The absence of a concise presentation of the results in the press release, and in particular the lack of a direct comparison of these results to the competition, continues to highlight the most important combination therapy needed: the need to combine an “A” team with the “A” product. If done right, readers (including potential investors) would have immediately known the superiority of the solution versus the competition and the press release, along with the AP pickup , would have also shown up on boards such as EYET and DNA to attract new investors. Another opportunity lost, in what seems to be a never ending list.
Before addressing the combination issue, there is an important flaw they need to correct in the stand alone therapy: the treatment regimen of 4 weeks is too short. The superior results of Evizon are as I predicted a long time ago because of the activated endothelial cytotoxic MOA , which provides active kill back of over proliferating blood vessels versus cytostatics such as Lucentis or Macugen which can only prevent new growth (posts 33920, 34431, 56719, and 56989). However, the short regimen prevents the full realization of Evizon’s potential to make Lucentis and Macugen look like a placebo and more important it does not provide patients with the full medical benefit inherent in the drug and its MOA (posts 56719 and 56770 - with typo correction of -1.5 vs. 1.5 in post 56719). I cannot fathom what possessed the folks at GENR to use such an insanely short duration regimen.
As for combinations, the combination of Evizon with either a direct intravitreal injection of VEGF or use of non intrusive VEGF inducing procedure was something I predicted well before GENR’s announcements of trials in this area (posts 41626 an 41659 ). The one smart thing Levitt did last year is start clinical trials of Evizon with Visudyne. Not only should this have great trial results based on the MOA, but it would put GENR in a position to leapfrog the competition into the market at minimal cost (post 56203 made prior to macugen approval). The combination of VEGF or VEGF inducing procedure with Evizon, an activated endothelial cytotoxic, could potentially also give GENR a market onto itself - restoration of vision in people that are already blind from overproliferation of blood vessels (post 41659) which is something GENR should also start clinical trials in.
The combination they should never do is mix Evizon, an activated endothelial cytotoxic, with cytostatics such as Macugen or Lucentis that are VEGF antibodies or VEGF receptor blockers. These types of cytostatics will prevent endothelial activation, which would prevent Evizon from working ( in a manner analogous to how Genentech’s Herceptin - a HER2 receptor binder - was inappropriately used to protect tumors from 5 of 6 cell cycle active cytotoxic administrations in the Trastuzumab clinical trial protocols described in Herceptin’s full prescribing information).
Hope that answers your combination therapy questions.
Best,
Mark Z., San Jose, CA
FWIW - Just started DD on POSS Medical
Has anyone reviewed POSS and the Angiojet device?
TIA
Pardon my stupidity, but how would I respond to your survey since I am not a lurker?
AMD-Related story continued...
Come to think of it, this was the same company that Paul Harvey's radio commercial was promoting last year when I first heard the radio commerical in April 2004.
Both AlohaDan (message #1866) and ello (message #1936) identified the offending company cited at the following links...
https://www.quick2you.com/store/index.cfm?frm=details&piid=28&kw=occular_g
http://www.hihealth.com/shop/category.aspx?catid=1066
AMD-Related story
Lutein claims at the center of FTC settlement
http://www.nutraingredients-usa.com/news/news-ng.asp?n=58166-lutein-claims-at
2/17/2005 - The Federal Trade Commission (FTC) has settled with the seller of a supplement containing lutein over claims that the product could restore vision already lost form age related macular degeneration (AMD) and remove specks, known as ‘floaters’, from the field of vision.
Under a proposed administrative consent agreement, Scottsdale, Arizona-based Hi-Health Supermart Corporation will pay a $450,000 fine to the FTC and is banned from claiming that its Premier Formula for Ocular Nutrition-Optim3 product can restore vision or eliminate floaters, unless it has competent, reliable scientific evidence to support the claims.
The commission alleges that the company stated its claims were backed up by nutritional studies in responsible medical journals but, according to the FTC, no such studies have appeared in medical journals.
It draws attention to a statement issued by the National Eye Institute in November 2002, which says: “Claims made about an association between lutein and eye health are speculative and should be viewed with caution. The possible benefits of lutein for the eye remain uncertain.”
Although the statement adds that there is little definitive scientific evidence at this time to support claims that taking supplements containing lutein can decrease the risk of developing advanced age-related macular degeneration, a blinding eye disease, or cataract, it concedes the existence of studies examining trends in a population which suggest a link between lutein and decreased risk of eye disease.
A 4-capsule dose of Ocular Nutrition contains 10mg of marigold-derived FloraGLO brand lutein, supplied by Kemin.
Kemin has examined the results of 19 studies carried out in the past few years (a list of which is available on its website) that have linked lutein intake to a decreased risk of developing eye and other health-related disorders. Amongst several key conclusions it drew were that a diet containing 6mg of lutein per day led to a 57 percent lower prevalence of AMD and that lutein protects the retina by blocking out harmful blue light.
The FTC’s complaint around a nationwide radio advertising campaign between January 2002 and June 2004, primarily through testimonials and statements read on the Paul Harvey News and Comment show, which is sponsored by Hi-Health.
In addition to the claims surrounding the properties of the products and scientific studies, the FTC alleges the company falsely asserted that 83 percent of ophthalmologists recommend or prescribe it to treat age-related macular degeneration and cataracts.
Hi-Health owner Simon Chalpin could not be reached for comment prior to publication.
Re GTCB question
Thanks for the confirmation. FWIW, I propose we have a 75% chance that we will hear something new and meaningful next week from Dr Cox. I have no facts or special insight, just a gut feeling. :)
GTCB question
I have not seen an update on the "unnamed" new-product partner which was apparently expected to be revealed late in 2004. Am I off base or perhaps have I missed an update by Dr Cox regarding this subject?
TIA
More from India - Gugulsterones
Guggulipids – are derived from the mixture of ketonic steroids from the gum oleoresin of Commiphora mukul and is an approved treatment of hyperlipidemia in India. It is a mainstay of Ayurvedic herbal approaches in preventing atherosclerosis. Clinical studies indicate it to be modestly effective in the treatment of both elevated cholesterol and triglyceride levels.
http://www.sabinsa.com/gug.htm
http://www.gugulipid.com
Very interesting reading........
on B.B.C. Headline News - "Goat confirmed with 'mad cow' first ever in France
http://news.bbc.co.uk/2/hi/europe/4216431.stm
Thx to Floblu14 on Yahoo GTCB board
Any thoughts? Does not sit well with me since so many individuals get emotional about their investments. Maybe a short term buying opportunity.....JMHO
Gemzar vs Gemzar plus Tarceva
http://www.msnbc.msn.com/id/6877393/
Smoking further linked to deadly pancreatic cancer
By Maggie Fox, Health
Updated: 4:58 p.m. ET Jan. 27, 2005
WASHINGTON - Smoking may speed the growth of pancreatic cancer by causing it to develop in younger people, U.S. researchers reported on Thursday.
The study, presented at a meeting of cancer specialists in Chicago, may help doctors better understand a particularly deadly cancer, which kills virtually all of its victims within a year.
Dr. Randall Brand and colleagues at Northwestern University in Illinois studied 18,346 pancreatic cancer patients treated between 1993 and 2003. The patients, taken from a database of 350 hospitals around the country, all gave smoking histories.
"Smoking appears to accelerate the onset of pancreatic cancer development," Brand told a news conference.
The median age for the patients was 73. But current smokers were diagnosed at 63 -- a full 10 years sooner. People who had smoked in the past and quit were diagnosed at age 70.
Brand said other studies have indicated that smoking can affect both the initial development and spread of cancer.
"Since the age of diagnosis of previous smokers was younger than nonsmokers, this suggests that smoking could impact upon the initiation phase," Brand said.
In 2005, an estimated 32,180 people will be diagnosed with pancreatic cancer, and 31,800 people will die from it, according to American Cancer Society projections. It is the fourth leading cause of cancer death.
"Since pancreatic cancer is almost uniformly fatal, a younger age of onset means more potential years of life lost. Thus, these findings offer yet another important reason for individuals not only to stop smoking, but never to start," Brand said.
Smoking also causes lung, esophageal and bladder cancer, among others.
A second study presented at the meeting of the American Society of Clinical Oncology found that adding a new drug to standard chemotherapy for pancreatic cancer gave some patients a few extra weeks of life.
The new drug, erlotinib, is sold under the brand name Tarceva by Genentech Inc. and OSI Pharmaceuticals Inc. and is one of a new generation of targeted cancer drugs that affects a molecule used by tumor cells to grow.
For the study, half of a group of 569 pancreatic cancer patients got a standard therapy, Eli Lilly & Co.'s gemcitabine or Gemzar, while the other half got Gemzar plus Tarceva.
After a year, 24 percent of the patients who got Tarceva were alive, compared to 17 percent of patients given Gemzar alone.
"This is a difficult disease to treat," said Dr. Malcolm Moore of Canada's National Cancer Institute, who led the trial. "This is a bit of a light and gives us some clues about how we can improve the treatment of this condition."
Randy,
Was this a gut feeling that you had about GTCB? BTW, what do you make (if anything) of the buy/sell messages at the following link?
http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_ticker?ticker=gtcb
Rich
Conference may spawn research into supplements’ effects on blood-thinners
http://www.nutraingredients-usa.com/news/news-ng.asp?n=57232-conference-may-spawn
1/11/2005 - The National Heart, Lung, and Blood Institute (NHLBI) is convening a conference this week to assess the dangers of combining dietary supplements with prescription blood-thinning medications – and which may lead to scientific research on the subject.
Four million Americans currently use prescribed anti-thrombotic (anti-coagulant or anti-platelet) therapies to reduce the risk of heart attack and stroke.
A new generation of agents is being introduced and use of dietary supplements is proliferating as the wider population becomes more conscious of health and wellness issues.
“With up to 52 percent of the US population reporting dietary supplement use, it is important that we fully understand how these substances can affect widely-used drugs, such as warfarin and aspirin,” said NHLBI acting director Barbara Alving.
Few examinations have looked at the effects of dietary supplements when taken with blood-thinning drugs, and so the conference – to be held on 13-14 January at the NIH in Bethesda, Maryland – will be an opportunity for NIH and FDA experts to discuss current knowledge and strategies with academics, patient advocacies and industry representatives.
“We plan to obtain a variety of perspectives on this issue so that we have a better understanding of managing patients' drug regimens,” said Ahmed Hasan, medical officer with NHLBI's division of blood diseases and resources.
“We are trying to increase awareness of both dietary supplements and anti-thrombonic therapies,” he told NutraIngredients-USA.
“The message to patients is that if you are taking a dietary supplement that has an active role, let the physician know. Similarly, the physician should actively ask whether the patient is taking any food supplements.”
If a need for further research on the subject is identified and approved by the NHLBI's institutional body, this will be sourced and funded by the organization. The stringent assessment process for applications usually takes between six and 12 months.
Around 180 dietary supplements – including herbal remedies, vitamins, minerals, botanical products, fibers, amino acids, proteins, organ tissues and metabolites for digestion – have the potential to interact with common blood-thinner warfarin.
More than 120 may interact with anti-platelet agents such as aspirin, and clopidogrel, ticlopidine, and dipyridamole.
2004
Happy Holidays to all! I sincerely wish you all of you the best in 2005. May you and your families be blessed with good health, friendship, love and success.
2004 was basically a limited year for us. The money available to us was tied up in GENR since buying in last October-2003. I believed in GENR enough to hold the issue not playing the "swing-trade" as others have suggested or practice. I do not have the time to monitor the daily or weekly moves. Also of equal importance I had the fear of missing the "big" move. Personally I am disappointed with the GENR timeline of recent. I am still invested, but my average pps is in the $4.20 area, so I'm in the red on this for now.
GTCB is my only other issue for now. Having accumulated over the last 2 weeks I am average in at $1.525......
Historically Enron burned me. IMHO those individual that say the "big" companies are a safer place to invest your monies are full of it...after returning from a business trip I ended up selling my Enron shares for $0.26. IMHO...Mr. Ken Lay and his buddies deserve prison. It was a setback for us, but at least I did not lose my retirement like some of those individuals who worked for Enron for years and lost it all.
2005....I will continue to hold GENR and GTCB and hope to better monitor the progress of both companies.
Thanks to all for your contributions to the I-Hub forum.
Have a safe New Year!
Pfizer to Stop Advertising Celebrex Drug
http://biz.yahoo.com/ap/041220/pfizer_celebrex_2.html
Monday December 20, 7:50 am ET
Pfizer to Immediately Stop Advertising Celebrex Pain Reliever to Consumers, Report Says
NEW YORK (AP) -- The maker of best-selling arthritis pain reliever Celebrex said it plans to immediately stop advertising the drug.
The move comes after a study showed high doses of Celebrex were associated with an increased heart attack risk.
New York-based Pfizer Inc. spent more than $70 million advertising Celebrex to U.S. consumers in the first nine months of this year.
The U.S. Food and Drug Administration, which said Friday it was considering warning labels for Celebrex or withdrawing the drug from the U.S. market, agreed with Pfizer's decision to halt advertising.
The move covers television, radio, newspaper and magazine advertising, Pfizer spokeswoman Mariann Caprino said.
"We discussed it with the FDA, and we all concurred that it was the appropriate step," Caprino told The New York Times.
Pfizer officials did not immediately return calls seeking comment left Sunday by The Associated Press.
Pfizer said it plans to keep Celebrex on the market and will continue marketing the drug to doctors.
Celebrex has not been shown to be dangerous to arthritis patients when taken at normal doses, Pfizer said. The heart attack risk in the study disclosed Friday occurred when patients took the drug at two to four times the usual dose for many months.
Sales of Celebrex and a related drug, Bextra, had been expected to total more than $4 billion worldwide in 2004, nearly 10 percent of Pfizer's revenue.
News of the increased heart risk for Celebrex patients came in one of two long-term cancer-prevention trials.
The National Cancer Institute, which was conducting the study for Pfizer, said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4 times greater risk of cardiovascular problems compared with a placebo.
For patients in the trial taking 400 milligrams of Celebrex, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.
Sorry...Reposted from yahoo... I ment to post these questions here. Thanks
Timeline of critical events
Should we concerned with this company's inability to "stick" to its guidance regarding the timeline of important events?
Answers to the EMEA’s ATryn questions. (Past due?)
The "new-product" partner originally expected to be revealed earlier this year. (Past due?)
The inking an ATryn partnership deal.
Submittion of an amended Investigational New Drug (IND) application. (Past due?)
[GTCB]
Does anyone who owns GTCB expect an announcement that they (GTCB) have submitted the answers to the EMEA’s ATryn questions for approval? Or is this a non-event.
What is the consensus for a partnership for ATryn?
Happy Holidays!
Rich
GENR related
Armstrong was awarded a modest 12,500 shares on October 27. Perhaps a "bonus" for completing a vital task?
Dew...Link does not seem to work at this moment. LLY is a client of mine and I very interested in following the company.
Thx
Re: Dr. Garren’s latest recommendations
Lastly, I received emails asking whether now is a good time to buy more Genaera (GENR). I think it probably is but I have enough in the Model and my personal account so I am not buying more. If you have a small position I would think of adding to it at current prices. My only concern is that the company hasn’t announced the 20mg and 40mg dosing results from the recent trial yet and if they expect them to be positive than the 10mg dose why did they finance before the release of the higher dose data. I have not talked with management since the recent financing (I talked with them the day before) so I have nothing more to add—but that is my note of caution.
OT - Nattokinase
Urche/Dew and or anyone else interested….I will be happy to provide a comprehensive description including MOA of this unique dietary supplement. After working with Amano on an unrelated project for several years specifically with Dr. Setsuko Jolly (now President of Amano USA) I have a tremendous level of trust and respect for her and the entire organization. If this is an inappropriate forum to provide a detailed outline of Nattokinase, please let me know where you would like information posted.
Best Regards
Rich
This is a dietary supplement that I personally take every day. Two years ago after I suffered from a DVT (deep vein thrombosis) behind my left knee, I started searching for either an approved drug (other than coumadin...aka warfrin) or a dietary supplement that may help prevent DVTs. Most dietary supplements have similar MOA like aspirin in that they may help prevent arterial blood clots, but not venous blood clots. The doctor I have spoken to strongly believes Nattokinase may prevent DVT's.
http://www.nutraingredientsusa.com/
Nattokinase to become functional food for hyper-tension sufferers
11/4/2004 - Nattokinase - an enzyme found in the Japanese food natto – that is increasing in popularity in the US as a supplement used by sufferers of high blood pressure and other cardiovascular conditions, should soon be available as a functional food with new clinical research behind it. Philippa Nuttall reports.
Nattokinase was launched onto the US market by Amano Enzyme three years ago. Since then sales of the supplement in capsule form have shot up, but the company now thinks the time is right to branch out and offer it in a variety of applications.
Kiran Krishnan from Amano Enzyme USA said that the company has received GRAS approval from the FDA and is currently looking at different ways in which nattokinase could be incorporated into a food.
“This could be confectionary, such as soft chews, or a drink or a snack bar,” he told NutraIngredientsUSA.com. “We have also been working with Nutri Granulations to put the supplement into a drink,” he said, adding that the company would like to launch a product in mid-2005.
Krishnan explained that the product’s packaging would target it at people suffering from hyper-tension.
Clinical trials carried out in 2003, which are now waiting for publication, seemed to show the efficacy of nattokinase in treating and preventing heart disease and stroke.
Amano Enzyme is now looking to the end of the year when it hopes to begin new trials in Chicago. One trial, Krishnan explained, will take 20 patients and look at the relationship between the new markers set for cardio-vascular disease and nattokinase.
A second study will aim to further the understanding of the link between nattokinase’s affect on blood viscosity – building on the results of last year’s research. And, thirdly, the company is working to design a specific in vivo clinical assay to measure a patient’s thrombolic activity when taking the supplement.
The group is also in talks with universities about setting up an animal model to prove clinically that the product works and how its efficiency compares to competing products.
Krishnan voiced his concern that other natto products on the market are not up to standard and could ruin the reputation of the supplement, particularly in the post-ephedra climate where the FDA is acting much quicker to remove products if there is any doubt about their safety and efficacy.
He fears that some distributors are simply looking at price rather than asking the right questions about the products.
NSK-SD nattokinase is a pro-fibrinolytic enzyme that helps to promote healthy circulation of the blood by breaking up cross linked fibrin and soluble fibrin monomers that may contribute to high blood pressure and other cardiovascular conditions.
Amano Enzyme claims that NSK-SD has the highest activity, greater than 20,000 fibrin units per gram, the highest levels of safety testing and the largest human clinical trials to date for nattokinase.
Krishnan said that in experiments carried out over the last six months by a Japanese university no other products - except NSK-SD - fitted the profile of nattokinase described by Dr Hiroyuki Sumi the scientist who discovered the enzyme.
To prove this, Krishnan said his company had developed an ELISA (Enzyme-Linked Immunosorbent Assay) designed to identify the characteristics of each enzyme structure.
“We found that our enzyme was identical to the structure agreed by Dr Sumi,” he said.
He added that for the purposes of these tests, the researchers looked at the other four companies – as far as he knows – who make nattokinase. Two from Japan, one from Korea and one from Taiwan.
Unlike Amano Enzyme, which has been around since 1890, the other companies have all been set up in recent years. Amano Enzyme is currently entering Europe, after three years of successful trade in the States.
“We began marketing nattokinase in the US in early 2002 and it is now our third most popular product out of a range of 50 products, including 30 dietary supplements, in terms of sales,” said Krishnan, adding that the two best-selling products have been on the market for around 10 years.
Doctors have started to regularly prescribe NSK-SD instead of blood pressure medication.
“Pre-reimbursement it is cheaper for the medical profession, working out at about 20 percent of the cost of a prescription drug,” said Krishnan. Notwithstanding the cost, he noted that many patients prefer to take a supplement because it has less side effects.
Thx....Biowatch...Got your comments the other day about the Cubs and Red Sox. As most of us Chicago Cubs fans say...there is always next year! :)
That’s a red herring
Ok...I admit to being weak on my English skills. Please define or further explain this statement if you wouldn't mind.
Thanks...PS Did you ever get a chance to view the email I sent to your attention?
Regards
Thanks Randy for sharing. We hope your family member will be much better. Best Regards
Thanks Randy!
May I ask how you obtained this information?
Best Regards
Another question
If the "Interim Results" at the two other dose concentrations (20 mg & 40 mg) from the 207 study (pharmacokinetic study) uncovered "some" potential safety issues related to the higher concentrations, would GENR management be required to halt the current enrollment of other PII studies?
civic
Thanks for sharing you comments regarding the R&R Conference. Did anyone ask Dr. Levitt at the breakout session about if "Interim Results" at the two other dose concentrations (20 mg & 40 mg) from the 207 study would be made public?
Thx
may be signaling some consequential changes
Possible drug interactions with squalamine that were previously unobserved?
R&R Presentation
I have listened to the 20-minute fumble presented at the R&R event. Although the presentation was weak (IMHO), I did not pick-up any nuances that lead me to believe that GENR management is feeding us investors BS. For what is worth, I continue to believe that Roy, et al is pushing for the best deal for us shareholders, but as Dew has previously stated, GENR may be over-playing their position in their discussion with the potential partner(s).
Congrats to the Boston Red Sox!!! Now if only my beloved Chicago Cubs could make it to the World Series and actually win before I die……………
GTCB
Excellent presentation!
I wish Roy could speak as well.