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- Four Drug Companies Vying for Diabetes Patients [view article]
- Oncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
- ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
- Drug Blockbuster - Cramer's Mad Money (7/31/08) [view article]
- NordiCaps Regional Stock Index: Tracking Scandinavia's Finest [view article]
- Diabetes Stocks Remain Healthy [view article]
- Credit Suisse Healthier 15: Investors Get the Skinny on Fat Fighters [view article]
- Novo Nordisk Donates Compound Library to China Center [view article]
- Is Lilly and Amylin's Byetta Better? [view article]
- Fast Money Recap - Oil Spoils Everything (6/6/08) [view article]
- Generex Biotech's Oral-lyn Granted Special Access Authorization by Health Canada [view article]
- Biotech in Review: Investment Capital for China Biopharma [view article]
Recent NVO Articles
- AstraZeneca Gives FluMist Spray a Shot in the Arm
- Four Drug Companies Vying for Diabetes Patients
- NordiCaps Regional Stock Index: Tracking Scandinavia's Finest
- Credit Suisse Healthier 15: Investors Get the Skinny on Fat Fighters
- Diabetes Stocks Remain Healthy
- Is Lilly and Amylin's Byetta Better?
- ADA's 68th Scientific Sessions: A New Look at Insulin Therapy
- Fast Money Recap - Oil Spoils Everything (6/6/08)
- Analyst Notes: Lilly Gets A Lift, Pfizer Goes Pfft
- Oncology Conference Countdown: What Will Pharma and Biotech Companies Report?
- Full List of Articles »
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Four Drug Companies Vying for Diabetes Patients [view article]
Hi GreenClay,Generex has conducted dose-response studies on their buccal insulin spray. Their patented Rapidmist delivery device has been found to bring precision dosing where each spray measures approx 1 Unit- of Oral-lyn human insulin from the first spray to the last. This allows for tight titration and is one of the main positive features of Oral-lyn. If you email the company at generex.com, they can send you the published data from the peer review (I believe the report was dated 2005).
There are no pills or syrup this far along in Phase testing. Oramed and Biocon have pills that are in very early Phase IIa, and one has a pill whose dose measures 8 mg and the other measures 10 mg. Both have tested their pills in a small handful of patients. I have followed both, and Emisphere also has promising platform technology, but has had difficulties in translating their research into a successful pill form.
Exubera was also measured in mg, and not the unit that diabetics, such as yourself, are familiar with. Their dosing was confusing and one of the many reasons for its lack of success.
An effective oral one unit dose should make things easier to calculate, depending on weight and carbs per meal. The low dose aspect would be a negative if many units are required for certain Type 1's. It is interesting that Generex is set to begin a diabetes preventive trial for those that are pre-diabetic or at risk of developling diabetes. This is similar to TrialNet, and is an area to watch for future developments. Reply
Four Drug Companies Vying for Diabetes Patients [view article]
As a major biotech investor and as a diabetic who has been on insulin for 23 years allow me to add my 2 cents.Oral insulin sprays may be effectively absorbed but how one titrates the insulin is beyond my ken. As someone who regularly monitors his blood glucose (BG) using at least 7 test strips a day to accomplish this I know how difficult a task it is to have ones hemoglobin A1C approach normal which is how I've survived so far without any major diabetic encumbrances.
Oral insulin (tablets or syrup) can be measured, sprays are very difficult. Reply
Four Drug Companies Vying for Diabetes Patients [view article]
DMYDY, Pink sheets, advanced stage potential Type 1 cure, highly illiquid put in a bid about $1 above last indicated trade for up to 500 shares, try to buy more and you will drive the price up by your lonesome. ReplyFour Drug Companies Vying for Diabetes Patients [view article]
Gnbt:: a possible buy out candidate. ReplyFour Drug Companies Vying for Diabetes Patients [view article]
RJS is full of bull. I beleived him once, not anymore. ReplyLepoff, M.D.
Oncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
Dear Mr. Mizerak,I am a reitired Ophthalmologist. I am not sure I haev the expertise you need. Reply
ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
GNBT is up for acquistion. Most of the big players scratched their research in Oral-lyn except GNBT. Big player will be waiting to see the results from Ph III and will price it some where in between $2 - $3. In such case there will be no dilusion in stock ownership. In current market anything that need finance is downgraded no matter how great the product or business model is. Replyks
Drug Blockbuster - Cramer's Mad Money (7/31/08) [view article]
It seems like that Liraglutide is a short term fix for a bigger problem. Solution: Get the kids off the couch, off the computer, stop eating & drinking crap, get some exercise and get some good sleep. This will result in a happier / healthier kid - not a drugged up kid.Just my opinion Reply
ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
"the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;)"I'll redo that one! LOL. I was watching the Yankee game and typing.
The downtrend was not accompanied by any substantial volume, and that is an area we may draw comfort. ;) Reply
ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
I think part of the problem has to do with the overall state of the market and how that has caused some problems for baby microcap biotechs such as Generex. All of the news coming from Generex has been positive- from new Phase II data for Oral-lyn regarding a one year and 372 day study in Type 1 diabetes to the positive AE37 results that were just published with the USMCI and Walter Reed in the Journal of Clinical Oncology.If we look at what they are doing in the clinic, which is what is important, we see they have one Phase III (Oral-lyn) and one Phase II (AE37 in breast cancer) underway for drugs targeting diabetes and cancer. Metcontrol Gum will probably be an Abbreviated Submission and their next trial looks set to begin. The wholly owned subsidiary, Antigen Express, also has two Phase I's that are dosing and three other vaccines (AE37 Combo with/and funded by Mary Crowley Medical, the melanoma vaccine with the Mayo Clinic, and the RNAi/Ii-key with Dr. Daopei Lu in Beijing) getting ready for human trials. The HIV DNA vaccine could pop up sometime in late 2008.
But financing also occured a couple of months back that may have added 30 mm shares to the outstanding total, and we will see in the 10K (Oct 2009) what the current OS total equals. That may have augmented the woes seen in the market, because there appears to be no bad news associated with the company or stock. Pending early approvals in the Middle East or Asia (China) for Oral-lyn may sneak up and lift the stock, as well as any other positive developments that the company announces.
Oral-lyn was featured on FOX News Health segment this week with Generex's Dr. Gerald Bernstein (former pres of the ADA):
www.foxnews.com/video2.../
I don't think delisting is a concern, because there is too much positive action occuring in the pipeline. They have 180 days to regain compliance and that should offer them enough room for announcing the type of news that will generate investor confidence. the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;) Reply
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ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
If GNBT is as promising as described then why is the stock dying at undr $1.00 for so long that it's in danger of being delisted? Can it be believed or not? ReplyOncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
Dear Dr. Norman Lepoff,I am a retired Principal Biochemist and recognized expert in carbohydrate chemistry with 5 US Patents. I have worked out a novel anti-cancer therapy that I would like to discuss with you in private rather than in a public forum. Can you send me your private contact information for a confidential yet thorough discussion? I think that you will be impressed. I ultimately hope to obtain from you the names of contact individuals in oncological research, preferably at the big pharmaceutical houses.
Thank you,
Robert J. Mizerak
(Oconomowoc, WI)
Reply
Diabetes Stocks Remain Healthy [view article]
The Pumpers: Better compliance for Insulin-dependent diabetic patients?With some diabetic patients, the hormone insulin may be absent, yet necessary for their survival. As I recall, a man named Pauescu developed the concept of insulin replacement, and discovered a method of using insulin secreted from pigs as a replacement method for humans, which was effective at that time. Legend has it that this concept originated in a dream this man had on a night soon before his idea became reality several decades ago. Yet presently, this hormone which is naturally produced by the pancreas normally has advanced as far as treatment goes for the diabetic patient through synthetic engineering, as this is needed for survival for some diabetic patients.
Recently, the Denver Bronco’s quarterback, Jay Cutler, was recently diagnosed with diabetes, a disease that affects over 20 million people. As I recall, part of his treatment regimen involves what is called an insulin pump. They are approximately the size of a cell phone, and the users of such pumps are called, in the diabetic community, ‘pumpers’. Developed primarily for type 1, or insulin-dependent diabetic patients, the pumps can be used by some type 2 diabetic patients if they have some dependence on insulin replacement, which has steadily increased over the years. The importance of the device is improved management of the disease, which can cause life-threatening consequences if the disease of diabetes is not controlled properly. By the way, he takes it off for games, practice, etc.
The three elements The Pumps: A New Paradigm in diabetes management of an insulin pump include the pump itself and its components, such as the insulin tube for delivery of insulin, and a catheter that delivers basal and bolus doses, which are dependent on preset calculations. The amount of insulin is rapid acting to ensure maximal pharmacokinetics to create intensive insulinotherapy for required diabetes management. These insulin amounts are ultimately determined by the patient’s doctor, who is usually an Endocrinologist, including bolus doses determined by the patients glucose level calculated with their carbohydrate intake, also known as the meal- time dose. Furthermore, the amount of insulin delivered by these methods is quite small due to the nature of the medication being rapid acting.
The makers of such pumps tend to partner with associations relevant to the disease of diabetes, as well as local chapters of such organizations as the ADA and Endocrinology societies that may exist, along with contacting diabetes educators frequently at different locations throughout the country. Unfortunately, there are few Endocrinologists in the United States, as it is not one of the more lucrative specialties of a doctor, so treatment of diabetes is dependent on many others who are not doctors, but patient care specialists regarding this disease.
Competing companies are few, as there are approximately 5 insulin pumps in the market, with Medtronic having the largest share of 30 percent, as I understand. In addition, some pumps avoid the possibility of metabolic action therapy due to their dosing precision, in addition, there is at least one pump that has long acting lithium battery that averages about a 6 week lifespan, yet a pump user should have a battery replacement with them at all times. The personalized insulin and carbohydrate ratio provided by insulin pumps greatly reduces any incidence of such complications as hypoglycemia. Also, in addition to storing and recording glucose and carbohydrate values with a back up mechanisms, some insulin pumps have a low basal rate, which I understand is an advantage as well. Regardless, and in my opinion, the ultimate advantages of insulin pumps exist with all that are available to patients presently.
The cartridges of the insulin pumps hold a large number of units of insulin, which is an additional benefit. Further benefits include the fact that the pumps are convenient and reliable- especially if damage is avoided to the pump. Most importantly, the personal service provided to the patients by the caregivers of existing diabetic teams in health care facilities from hospitals to health care centers dedicated to the disease of diabetes ensures proper management of their disease, much to the benefit of those who have diabetes.
The market growth of insulin pumps is anticipated at over 10 percent a year, as only 20 percent of type 1 diabetic patients have utilized these pumps out of over a million type 1 diabetics in the United States. The market is speculated to be greater than one billion dollars and is expected to increase due to speculated growth of the Insulin pump market. Many believe this therapy is superior in comparison with previous treatment options available to diabetic patients, along with being less cumbersome for these patients. Because of this, there is decreased mortality along with increased quality of life for diabetics, as they are assured of better control of their disease in this rather convenient way. This has been proven by better A1C blood tests and glycemic control of diabetic patients.
The steady dosing maintains the patient’s metabolic requirements and decreases long term consequences associated with diabetics. It has also been proven that insulin pumps result in fewer hospitalizations, ER visits, and episodes of hypoglycemia due to the excellent control provided by the insulin pumps while providing the necessary intensive therapy for their disease state. The fast acting insulin used in these pumps is created through genetic engineering, I believe. In addition, patients are encouraged to check their blood sugar greater than three times a day while on the insulin pump. So this system is both friendly to the user and is clearly a very convenient form of treatment for them. The A1C test, by the way, is a blood test that reflects the diabetic patient’s average blood sugar over a period of a few months.
Those who may be interested in insulin pumps will include those described already, along with hospitals, long term care facilities, home health care agencies, pediatricians, and possibly dialysis clinics, to name a few. Most likely, those considered for insulin pumps will be diabetic patients that are unable to achieve compliance with their current treatment regimen, along with other benefits of insulin pumps stated so far.
The diabetes team for a diabetic patient may include an Endocrinologist, a diabetes educator, a dietician, along with the insulin pump representative. Follow ups with this team may include review the progress of the insulin pump for the patient and how the patient is tolerating the treatment. Often, classes can be scheduled through an institution or center regarding insulin pump training a few times a month. Education and training about the insulin pump may include the following:
1. Glycemic control importance and how to prevent and treat as needed
2. Basal and bolus concepts and how they contribute to the treatment
3. Pump basics and strategies. Negative effects stressed to pt. if their pump is not used properly.
4. Importance of knowing blood sugar and why. Definitions of terms like A1C
5. How to deliver a bolus dose after checking carbohydrate intake
6. How to check the pump’s memory
7. Troubleshooting, phone number access, and how to replace battery
8. Emphasize the safety of the insulin pump if operated correctly
9. Keeping a glucagon injection and spare battery with you
Ultimately after training others, it is important that the patient acknowledges understanding of how the device works, as well as the consequences that may occur if directions are not followed that are ultimately determined by the patients doctor. And fortunately, doctors and others who treat diabetes now have a new tool or device to assure compliance and longevity of these patients.
Innovation is a wonderful thing, such as what has been described. Control of such a large and devastating disease is of great importance, so there seems to be a much desired need for pumpers now and likely in the future. Especially for those patients who slack on following their prescribed treatment regimen. And this will have to do until relevant transplants to reverse diabetes become more frequent and less complicated.
“Death destroys a man. The idea of death saves him.” --- E.M. Forster
Dan Abshear
Author’ note: What has been annotated is based upon information and belief
Reply
ADA's 68th Scientific Sessions: A New Look at Insulin Therapy [view article]
There was a link in a posted comment there to an article about the event that I was talking about as being well written. Now I don't see it. That's funny, but I guess I'll now take the compliment to myself. LOL. ReplyJacome
Credit Suisse Healthier 15: Investors Get the Skinny on Fat Fighters [view article]
DKS has been a terrible investment for us, the St tested $30 level 3 times and then the stock snapped like a breadstick... Reply