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The big picture is last year they were laying off
and now they are hiring. they don't have much more money in the bank now than they had last year at this time.
This leads me to believe a deal will be forthcomming shortly.
Oxigene's drug has a different method of action from squalamine, if it does work they probably would complement each other.
I would think Qlti is probably afraid of non-invasive competitors like squalamine and oxigene's drug.
Article written by a VC
http://www.evelexa.com/archives/contributed/TheInvestmentDecision_e1.pdf
It appears there was a lot of nausea with AMLN's drug.
Conjuchem may have less nausea if it isn't given every day.
Concujem is trading with a market cap of about 120 million and is about 2 years behind AMLN which has a market cap of 2.5 billion based strictly on their glp-1 program than I would say it is worth the " hassle" to buy it on the toronto exchange. They will probably move to Nasdaq next year. You need a price of 4 a share to do that.
Amln's drug needs to be injected twice a day, this one is once or twice a week. They have an entire pipeline of hard to produce molecules that they will deliver in this way.
The novocell looks interesting but I think it is very early and the FDA will probably give them a hard time and be very careful before approving anything using that technology.
You can listen to an amazing conference call
if you click on this link
http://www.startcast.com/shows/8/A0107/
people always mention nstk when they talk about nasal delvery.
The problem is that intrnasal delivery will usually cause abrasion to the inside of the nostril. Bentley pharmaceuticals has an non-abrasive intanasal delivery system and I don't see any negative in that type of administration as long as the molecule isn't too large to be delivered that way.
I don't believe these molecules are too large. I think it would work fine
What do you think of this company cjc.to conjuchem
working on a better glp molecule. Same target that has amln at a 2.5 billion dollar market cap
http://www.wallstreetreporter.com/profiles/ConjuChem.html
from genaera website regarding obesity product
Obesity Therapeutic Program
Trodulamine (MSI-1436) is another natural aminosterol product candidate. Our scientists have demonstrated the ability to reduce the weight of genetically altered mice, generally very obese mice about 10 times their normal size, to that of a normal healthy mouse. Body weights of healthy animals, including animals with diet-induced obesity, also have been reduced through the administration of trodulamine. Our researchers have shown preclinical efficacy with trodulamine, and demonstrated that animal food intake can be regulated in a reversible manner, leading to changes in body weight. Preclinical data on trodulamine demonstrate it is a potent appetite suppressant with the ability to normalize fasting blood sugar, as well as high blood cholesterol levels, resulting from weight loss in obese animals. With trodulamine, we are targeting the approximately 10 to 12 million Americans who are classified medically as significantly obese. While the trodulamine molecule is very different in function, it has a similar chemical structure to squalamine, and thus would enable us to make more efficient use of internal and external resources already utilized for squalamine in its development. Preclinical results with trodulamine suggest that additional work on formulation and delivery of this compound in a safer and more convenient fashion would be the next milestones for development, if a business partnership or program-specific funding can be obtained. Further preclinical development work will be needed before an Investigational New Drug application can be filed with the FDA. Due to the limitations of our current resources, we do not intend to actively pursue the development of this product candidate at this time but we continue to seek new opportunities that will enable us to capitalize on our past development efforts in this program.
This drug targets npy and agrp. Do your searches, researchers are looking for inhibitors of these proteins and we have it.
Right now it is an injection, when they figure out how they will deliver squalamine they will probably be able to use the same delivery system for trodulamine
I see the abstract in nature is dated 09/29/03.
That means it was published before the 4 month data and probably accepted for publication before the 2 month data was released on 08/04/03.
visudyne phase 1/2 data
here is the data from the phase 1/2 trial visudyne performed.
About 50 minutes into the qlti conference call Mathew Geller of CIBC asked hastings what visudyne's phase 1/2 data showed and hastings said a 45 percent improvement.
That was a little fib. There was one subset of patients that had several retreatments. In that small subset, 4 out of 11 patients, with 11 drop outs, show a 3 line improvement, but that was an unacceptable treatment method as exhibited but the high drop out rate.
Qlti's conference call seemed to really coincide with the genr drop from 4.60 to under 4 the day following the conference call. I wonder if that comment was why
here is the abstact
Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration: results of a single treatment in a phase 1 and 2 study.
Miller JW, Schmidt-Erfurth U, Sickenberg M, Pournaras CJ, Laqua H, Barbazetto I, Zografos L, Piguet B, Donati G, Lane AM, Birngruber R, van den Berg H, Strong A, Manjuris U, Gray T, Fsadni M, Bressler NM, Gragoudas ES.
Retina Service, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA. jwmiller@meei.harvard.edu
OBJECTIVE: To evaluate the safety and short-term visual and fluorescein angiographic effects of a single photodynamic therapy treatment with verteporfin with the use of different dosage regimens in patients with choroidal neovascularization (CNV) from age-related macular degeneration. DESIGN: Nonrandomized, multicenter, open-label, clinical trial using 5 dosage regimens. SETTING: Four ophthalmic centers in North America and Europe providing retinal care. PARTICIPANTS: Patients with subfoveal CNV caused by age-related macular degeneration. METHODS: Standardized protocol refraction, visual acuity testing, ophthalmic examination, color photographs, and fluorescein angiograms were used to evaluate the effects of a single treatment of photodynamic therapy with verteporfin. Follow-up was planned through 3 months in 97 patients and for less than 3 months in 31 other patients. RESULTS: The mean visual acuity change (and range of change) from baseline at the follow-up examination at week 12 after a single treatment with regimens 1 through 5 was -0.2 (-3 to +2), -0.9 (-9 to +5), -1.6 (-9 to +2), +0.4 (-8 to +7), and +0.1 (-8 to +9) lines, respectively. Only the highest light dose (150 J/cm2) in regimens 2 and 3, which produced angiographic nonperfusion of neurosensory retinal vessels, caused marked vision loss. Some cessation of fluorescein leakage from CNV was achieved without loss of vision when the light dose used was less than 150 J/cm2. Systemic adverse events were rare. Cessation of fluorescein leakage from CNV was noted in all regimens by 1 week after photodynamic therapy. Fluorescein leakage from at least a portion of the CNV reappeared by 4 to 12 weeks after treatment in almost all cases. Progression of classic CNV beyond the area of CNV identified before treatment was noted in 42 (51%) of the 83 eyes with classic CNV followed up for 3 months after a single treatment. Eyes in which the area of any CNV leakage at 12 weeks was less than at baseline had a significantly better visual acuity outcome (+0.8 line) than eyes in which CNV leakage progressed (-0.8 line). CONCLUSIONS: Photodynamic therapy with verteporfin achieved short-term cessation of fluorescein leakage from CNV without loss of vision or growth of classic CNV in some patients with age-related macular degeneration. Except for nonperfusion of neurosensory retinal vessels at a light dose of 150 J/cm2, no other adverse events were of concern. Randomized clinical trials to investigate whether this new modality can preserve vision in patients with CNV secondary to age-related macular degeneration are justified.
There was an analyst meeting at the four season hotel after the 2 month data was released.
and dr. levitt said in intradermal or intranasal formulation was probable.
I was at the four seasons presentation that genr had
a couple of months ago. They said an intranasal version of squalamine is entirely possible, but they would be looking for their partner to fool around with it.
Bentley pharmaceuticals has intranasal technology that would work. I am sure ntsk could do it also. It is a small molecule, it shouldn't be a problem.
can squalamine go directly into phase 3
Here is an example of a company that did an open label(no placebo) trial, in another country(Israel)and is going into a phase 3.
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ptie&script=410&layout=-6&item_id...
So, I think there would be a way to get it done. I think the only thing holding it back would be not knowing what the proper maintenance dosing should be. Every 4 weeks, 8weeks, 12 weeks. You want to get the best result because nothing is a slam dunk.
dew, I beat you, I bought at 3.90
I just spoke to someone that got off the phone with the company.
They are NOT doing a financing right now.
It looks to me like a secondary
It looks like there is shorting. No one in their right minds would be shorting based on valuation. What I believe is happening is the funds have been offered to invest in a pipe. These are usually at a discount to the market closing price for an average of 5 to 10 days. What then happens is the funds can cover their shorts with the shares as they register, like what biotech value fund did.
that would be the only thing that could explain the dumping with absolutely no fear.
I hope we wake up tomorrow and see it priced.
Where is everyone
Who thinks that was biotech value fund shitting out his last block?
All the other sales were carefully done. This seemed to be a last gasp of someone that didn't care what happened to the stock.
dew have you ever tried melatonin
http://my.webmd.com/content/article/75/89832.htm?z=1728_00000_1000_ln_02
The stock is now trading at a price
before it picked up both analysts, caris and fortis
The great 4 month data on macular degeneration was announced.
The good,but not great,lomucin data was announced. It now has value.
It doesn't make any sense, and don't try to make any sense out of it.
It didn't make any sense when I started buying this at under a dollar in august 2002. I tried to figure out why I was buying it while the funds were selling it. What did they know that I didn't. The answer was NOTHING.
I was right and they were wrong, and I am right now. The squalamine deal is worth multiples of the Eyetech deal and Regeneron deal and the best part is Roy knows it.
Why be concerned about the trial being done in Mexico. Regeneron did their deal with Aventis and they didn't even have any human data.
Got it!
It appears that the 25 mg dose is more than enough, so a dosing regimen would probably not be needed for the study.
In the upcomming phase 2 it seems that they should try a maintenance dose of one month for some patients, and 2 months for another group, of course the people getting the maintenance every 2 months would get a placebo, at the in -between months.
I have the feeling that as you say, they could probably get by, with the every 2 month dosing and still beat the competition, but WHAT IF the monthly maintenance improves vision TREMENDOUSLY. Wouldn't it then be worth doing.
They won't know until they try. The phase 2 is not a place to skimp on costs.
They had no choice but to skimp before, because the cash situation and the access to funds, made it neccessary to do the trial the way they did, in order to avoid the black hole of being a biotech without cash. A lot has changed in the past year.
The company's technology would have either been bought out of bankcrupcy or some vc. would have forced a dilutive event that would have caused all the shareholders to get pennies on the dollar. Thank goodness Roy thought of doing the trials in Mexico.
Genaera, I don't believe has the technology to deliver the squalamine intranasally, but either a partner would, or they license a technology from a bently pharamaceuticals, or a company like that.
Genaera, I don't believe has the technology to deliver the squalamine intranasally, but either a partner would, or they license a technology from a bently pharamaceuticals, or a company like that.
nicksdad,
As I stated previously, and the p/r from ppl showed, the genaera results weren't powered to show a statistically significant" result, with only 55 patients enrolled and a 4 week dosing regimen.
The proof of concept trial showed that the people on the drug seemed to improve a tiny bit while the placebo group kept deteriorating. In CF that is a homerun.
Unfortunately for genr it was a single or double because it didn't knock anyone's socks off, and the stupid Dow Jones article said it failed to meet statistical significance even though it wasn't powered to. Day traders and morons that shouldn't be in the market saw the term and sold.
As I previously mentioned Genr and CF foundation will be going through the data looking for data on subsets. It could be that the drug worked better on milder cases for example. If that is the case the next trial may be in milder cases.
The one thing I am surprised about is that they should have kept people on the drug for at least 3 months in an open label setting to see if they kept making improvements the longer the drug was used. This could have helped when structuring the new trial.
Good post Red,
The fda will not allow genr to enter a phase 3 based on the trial in Mexico. It was a proof of concept trial and the results were as hoped.
I think genr is at the point where they can do their 125 to 150 million up front deal with a big pharma.
One thing that no one has brought up has been a different delivery system for squalamine. I believe in the next phase 2 you will not see 4 weekly infusions but an intranasal or intradermal delivery making it more user friendly.
It will also make the maintenance therapy more conveniant. Anyway after the deal is done it will be in big pharma's hands and they will know how to run with it.
genr will then be able to concentrate on hclca1(mucoregulator) and msi-1436(obesity and diabetes)
post regarding the cystic fibrosis trial off ppl
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=7077012&tid=magn&sid=707...
I thought it was important in case members here didn't see it on yahoo.
I think I may know who ridgerunner is. I will ask him to post on this site.
The reason I mentioned raging bull, is because it is a public site and I felt we would get more worthwhile newbies there. This board may be hard for new potential investors to find. All they will see is the garbage on yahoo and leave.
cheers