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mcu mph
There is a board on Ihub I made a couple of posts on.
If you find anything useful you may want to post it there.
the post you made here would be fine also
article posted by big money picks on ymb
The importance of this old article hasn't diminished by time. There aren't many late stage cardiovascular drugs up for licensing. With statins and arbs comming off of patent protection the fact that mc-1 has all of the patents in this area this could lead to a large deal
There will be howls of joy or buckets of tears coming out of drug developer Medicure Inc. over the next few weeks.
The Winnipeg-based company has completed two mid-stage clinical trials with its MC-1 flagship drug and is set to release those results by mid-September and late October. And without enough money in the bank to continue large-scale testing on its own, the company needs a positive outcome to pave the way for a corporate partnership with a drug company to finish development.
Success here could target cardiovascular markets in the billions of dollars, either with MC-1 on its own or in combination with other heart drugs. So far, the company has invested $25-million in developing the drug.
"I'm not superstitious but we've been very fortunate developing MC-1 so far," said Medicure president and chief executive officer Albert Friesen, who is known as the founding father of biotechnology in Manitoba.
Medicure and MC-1 trace their roots to a business lunch in Winnipeg nine years ago. As a trained chemist and CEO of Novopharm Biotech Inc. at the time, Mr. Friesen recalls how impressed he was with University of Manitoba professor Naranjan Dhalla's drug discovery.
"What hit me was the beauty of the molecule, how safe it is and the huge opportunity in cardiovascular disease," he recalls. Mr. Dhalla is now chief scientific officer of Medicure.
Mr. Friesen's claim to fame, however, precedes founding Novopharm, which is now Viventia Biotech Inc. In 1969, he was the first employee of the Winnipeg Rh Institute, which pioneered development of the WinRho drug to protect newborns from anemia, heart failure and brain damage associated with Rh disease.
The drug was approved by Health Canada in 1980. WinRho is also used to treat a clotting disorder known as ITP.
Mr. Friesen also began WinRho's approval process with the U.S. Food and Drug Administration until the institute was acquired in a hostile takeover by Toronto-based Apotex Inc. and became Cangene Inc.
"MC-1 was a chance to take an idea all the way to the marketplace again," he said.
MC-1 is what's called a metabolite of vitamin B6, one of three chemical compounds left over from reactions between the vitamin and enzymes in the body. The metabolite binds naturally with the protein albumin, circulates in the blood and is slowly released in the heart and other organs.
What impresses analysts about MC-1 is that it is a new drug class, with the potential to reduce damage to heart tissue.
"Our belief is that Medicure may be able to build a business solely on using MC-1 in combination with other therapies," National Bank Financial analyst André Uddin said in a recent research report.
After posting positive results in an earlier mid-stage study with patients undergoing an angioplasty procedure, Medicure combined MC-1 with an angiotensin-converting enzyme (ACE) inhibitor, which is used to treat high blood pressure. The combined therapy, known as MC-4232, was then used to test 120 diabetic patients with hypertension to see if it would reduce blood pressure, triglycerides and blood glucose levels. Those study results are set to be released in the next few weeks.
Medicure has at least three other combination drugs in early research for heart disease.
In late October, the company will learn how MC-1 performed on its own with 900 patients undergoing coronary bypass surgery. The Phase II study is not designed to show statistical significance, which could make investors skittish, but rather a trend toward reducing heart attacks and strokes in the first 30 days after surgery.
If we can show a reduction of 15 to 25 per cent in clinical events, it would be a home run," Mr. Friesen said. "If we succeed, I believe we have a high probability to repeat in a pivotal Phase III study."
He said Medicure is in "active discussions" to team up with a large drug company specializing in cardiovascular disease and mid-sized specialty drug companies to take MC-1 into late-stage clinical testing, which could require several thousand patients.
"When I started Medicure, I thought it would take 10 to 13 years to develop MC-1 and we're still on schedule."
I met with cbli, The cso is more credible in person than he is in his press releases.
Do you think the test will sell?
Quidel has a flu test and its market cap is over 400 million. Response's test is more accurate and they will have 3M selling it.
Will it sell?
biosite has a market cap of almost a billion mainly because of the bnp test. Response has a more accurate troponin test but they didn't have a bnp test so the hospitals didn't buy it.
they will now have a full cardiovascular panel. They will do a deal with a Roche or a J & J to market the test.
Will it sell?
What do you think?
read the following pdf but pay very close attention to pages 6 and 7. Response's ramp system correlates extremely closely to the dade dimension analyser. Biosite's triage system isn't even close
Will it sell?
http://www.responsebio.com/pdf/Clinica%20Chimica%20Acta.pdf
New Drug Therapy To Combat Graft-vs.-host Disease In Stem-cell Patients Shows Significant Reduction In Deaths
http://www.sciencedaily.com/releases/2007/01/070123162031.htm
all this for a 40 million market cap and a buyout offer. this is Dor biopharma's drug dorb
Gastrointestinal graft-vs.-host disease is a common and potentially deadly side effect for patients who undergo an allogeneic stem-cell transplant to treat certain blood cancers. Now, new research from Fred Hutchinson Cancer Research Center shows that adding a widely used topical corticosteroid to the standard treatment for GVHD kept the disease in remission and significantly reduces deaths one year after therapy.
A reformulation of beclomethasone dipropionate (BDP) into two different pills specifically releasing the drug into the stomach and mid-small intestine prevented relapse of gastrointestinal GVHD and allowed those patients to be on a shorter treatment course of high-dose prednisone. Mortality was reduced by 46 percent a year following the start of treatment in a multi-center Phase III clinical trial, according to findings published today in the online edition of the journal Blood. The lead author is David M. Hockenbery, M.D., a member of the Clinical Research Division at the Hutchinson Center and a professor of medicine/gastroenterology at the University of Washington School of Medicine. BDP is an anti-inflammatory drug long used to treat a variety of diseases such as asthma and ulcerative colitis.
About 60 percent of patients who receive an allogeneic stem-cell transplant to treat blood cancers such as acute and chronic myelogenous leukemia, acute lymphocytic leukemia and non-Hodgkin's lymphoma develop gastrointestinal GVHD as a major side effect of being infused with donor stem cells. Those who show gastrointestinal symptoms of the disease usually receive a two to four-week course of high-dose systemic prednisone therapy that is then tapered slowly. However, that drug is a two-edged sword, Hockenbery said. On the one hand it is designed to suppress the donor cells so GVHD can be controlled. But suppressing the immune system also makes patients susceptible to potentially fatal infections.
In the clinical trial, 129 patients were randomized into two groups. One group received a short course of standard prednisone therapy and oral BDP for 50 days. The other group received a placebo in place of the oral BPD for the same period. At day 10, the prednisone dose was quickly tapered in patients whose symptoms had responded. Fewer patients randomized to BDP had a subsequent flare-up of GVHD. After completion of the 50-day treatment period, patients were followed for an additional 30 days to see if the treatment effect would last. Patients randomized to BDP had a significantly more durable response rate compared to those in the placebo group. At one year after treatment, mortality rates had been reduced 46 percent compared to the placebo group.
"Oral BDP provides much more tailored and targeted control of gastrointestinal GVHD and it allows patients to move away from the side effects of standard prednisone therapy. All of this improves the chances that patients will have a successful outcome," Hockenbery said. "I think this is a very convincing clinical trial because by targeting topical therapy to the areas most affected, we were able to keep symptoms at bay while minimizing systemic immune suppression."
The idea to reformulate BDP into an oral form for stem-cell-transplant patients belongs to George B. McDonald, M.D., one of the study co-authors and a colleague of Hockenbery's at the Hutchinson Center. McDonald, also a member of the Center's Clinical Research Division and a professor of medicine/gastroenterology at UW, initiated the early trials of oral BDP with funding from a U.S. Food & Drug Administration Orphan Products Development Grant. The goal was to target corticosteroid therapy to the areas of the GI tract affected by GVHD. The anti-inflammatory actions of the two BDP-containing pills would then be focused on the intestinal lining from top to bottom to suppress GVHD, thus avoiding excessive corticosteroid medication in the bloodstream.
The FDA is expected to decide whether to approve use of the oral form of the drug by July. If approved, it would be only the second drug approved by the FDA for treatment of GVHD in stem-cell transplant recipients.
The pivotal clinical trial was funded by an Orphan Products Development Grant of the U.S. Food & Drug Administration and by Enteron Pharmaceuticals Inc., a wholly-owned subsidiary of DOR BioPharma Inc. Fifteen other centers in the U.S. and France participated in the study. (Conflict of interest disclosure: George McDonald, M.D., is a consultant for Enteron Pharmaceuticals Inc. and has an equity position in the company.)
PL1
troponin I is used by biosite and is the most used test in the US
troponin t is used more in Europe
If you looked at the paper that details the troponin tests
responses test correlates over 90 percent to the lab analysers
biosite's correlation is much lower so equivalence is in the eye of the beholder and whether or not you are using your glasses when reading
Biosite has a technology which is much inferior to Response's ramp system
If you went on the website did you see the comparison of the ramp troponin data and its correlation to the slower and more expensive lab analyser's versus the Biosite correlation.
Once Response's BNP panel test is on the market why would a hospital use a test that doesn't correlate to the lab analysers
Dorb made omitted important data from their P/R
as you can see from the data below there was a 91 percent survival benefit in mismatched donors. one of the main reasons there aren't more transplants is that there aren't enough matched donors. With mismatched data like this the number of transplants will be increased because the efficacy in that population is terrific.
Blood First Edition Paper, prepublished online January 23, 2007; DOI 10.1182/blood-2006-05-021139. This Article
Submitted May 9, 2006
Accepted January 12, 2007
A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease
David M. Hockenbery, Scott Cruickshank, Timothy C, Rodell, Ted Gooley, Friedrich G Schuening, Scott D. Rowley, Donald David, Mark Brunvand, Brian Berryman, Sunil Abhyankar, Michelle E. Bouvier, and George B. McDonald*
Fred Hutchinson Cancer Research Center & University of Washington School of Medicine, Seattle, WA, United States
DOR BioPharma, Inc., Miami, FL, United States
Vanderbilt University School of Medicine, Nashville, TN, United States
Hackensack University Medical Center, Hackensack, NJ, United States
City of Hope National Medical Center, Duarte, CA, United States
Rocky Mountain Blood & Marrow Transplant Program, Denver, CO, United States
Baylor University School of Medicine, Dallas, TX, United States
Oncology & Hematology Associates, Kansas City, MO, United States
* Corresponding author; email: gmcdonal@fhcrc.org.
We tested the hypothesis that oral beclomethasone dipropionate (BDP) would control gastrointestinal graft-vs-host-disease (anorexia, vomiting, and diarrhea). Patients were randomized to prednisone for ten days and either oral BDP 8 mg/day (N=62) or placebo (N=67) tablets for fifty days. At Study Day-10, prednisone was rapidly tapered while continuing study drug. On an intent-to-treat basis, the risk of GVHD-treatment failure was reduced for the BDP group at Study Day-50 (hazard ratio 0.63, 95% CI 0.35-1.13) and at 30 days follow-up (HR 0.55, 95% CI 0.32, 0.93). Among patients eligible for prednisone taper at Study Day-10, the risk of GVHD-treatment failure was significantly reduced at both Study Days-50 and -80 (HR 0.39 and 0.38, respectively). By day-200 post-transplant, 5 patients randomized to BDP had died, compared to 16 deaths on placebo, a 67% reduction in the hazard of mortality (HR 0.33, p=0.03). In 47 recipients of unrelated and HLA-mismatched stem cells, mortality at transplant day-200 was reduced by 91% in the BDP group, compared to placebo (HR 0.09, p=0.02). The survival benefit was durable to one-year post-randomization. Oral BDP prevents relapses of gastrointestinal GVHD following tapering of prednisone; survival is statistically significantly better among patients receiving BDP.
orBec(R) Pivotal Phase 3 Clinical Trial Results Published in Journal "Blood"
Tuesday January 23, 3:00 pm ET
red, take a look at Dorb
Results Show Statistically Significant Improvements in Long-Term Survival in Patients With GI GVHD and Are Included in DOR's Pending NDA and MAA Filings
MIAMI, FL--(MARKET WIRE)--Jan 23, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) (DOR or the Company) announced that data from its pivotal Phase 3 and supportive Phase 2 clinical trials using orBec® (oral beclomethasone dipropionate, or BDP) to treat gastrointestinal Graft-versus-Host disease (GI GVHD) have been pre-published this afternoon in the online edition of Blood, the peer-reviewed Journal of the American Society of Hematology, as a First Edition paper, including long-term survival analyses from these two randomized, double-blinded, placebo-controlled trials not previously made public. Lead author of the study, entitled "A Randomized, Placebo-controlled Trial of Oral Beclomethasone Dipropionate as a Prednisone-Sparing Therapy for Gastrointestinal Graft-versus-Host Disease," is David M. Hockenbery, M.D., Member of the Clinical Research Division, Fred Hutchinson Cancer Research Center and Professor of Medicine, University of Washington School of Medicine, both located in Seattle, Washington. The full article is available online at www.bloodjournal.org.
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The Blood paper covers comprehensive results from two studies: DOR's 129-patient pivotal Phase 3, randomized, double-blinded, placebo-controlled multi-center clinical trial of orBec® conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France; and survival data from its 60-patient Phase 2, randomized, double-blinded, placebo-controlled clinical trial conducted at the Fred Hutchinson Cancer Research Center.
Comprehensive Long-Term Mortality Results
Among the new data reported today, orBec® showed continued survival benefit when compared to placebo one year after randomization in the pivotal Phase 3 trial. Overall, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test). Results from the Phase 2 trial also demonstrated enhanced long-term survival benefit with orBec® versus placebo. In that study, at one year after randomization, 6 of 31 patients (19%) in the orBec® group while 9 of 29 patients (31%) in the placebo group had died (45% reduction in mortality, p=0.26). Pooling the survival data from both trials demonstrated that the survival benefit of orBec® treatment was sustained long after orBec® was discontinued and extended well beyond 3 years after the transplant. As of September 25, 2005, median follow-up of patients in the two trials was 3.5 years (placebo patients) and 3.6 years (orBec® patients), with a range of 10.6 months to 11.1 years. The risk of mortality was 37% lower for patients randomized to orBec® compared with placebo (hazard ratio 0.63, p=0.03, stratified log-rank test).
"This is an important, validating milestone for DOR and its orBec® program. Publication of these data in Blood, one of the most prominent peer-review journals in hematology, further documents the strong safety profile and long-term survival benefit of orBec® in the treatment of GI GVHD," stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR BioPharma. "It is this comprehensive data package that is at the core of our regulatory filings with both the U.S. Food and Drug Administration and the European Medicines Evaluation Agency. We remain extremely confident on the impact orBec® can have on patients undergoing hematopoietic stem cell transplant and look forward to continued interactions with FDA and the EMEA regarding its potential regulatory approval."
200 Days Post Transplant Mortality Results
200 Days Post Transplant Mortality Results
Phase 3 trial Phase 2 trial
orBec® Placebo orBec® Placebo
Number of patients randomized 62 67 31 29
Number (%) who died 5 (8%) 16 (24%) 3 (10%) 6 (21%)
Hazard ratio
(95% confidence interval) 0.33 (0.12, 0.89) 0.47 (0.12, 1.87)
Death with infection* 3 (5%) 9 (13%) 2 (6%) 5 (17%)
Death with relapse* 3 (5%) 9 (13%) 1 (3%) 4 (14%)
*Some patients died with both infection and relapse of their underlying malignancy.
In the pivotal Phase 3 clinical trial, survival at the pre-specified endpoint of 200 days post-transplant showed a clinically meaningful and statistically significant result. According to the manuscript, "the risk of mortality during the 200-day post-transplant period was 67% lower with orBec® treatment compared to placebo treatment (hazard ratio 0.33; 95% CI: 0.12, 0.89; p=0.03, Wald chi-square test)." Although orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely time to treatment failure through Day 50 (p=0.1177), orBec® did achieve statistical significance in other key outcomes such as reduction in the risk of treatment failure through Day 80 (p=0.0226) and, most importantly, demonstrated a statistically significant long-term survival advantage compared with placebo. The most common proximate causes of death by transplant day-200 were relapse of the underlying malignancy and infection. Relapse of the hematologic malignancy had contributed to the deaths of 9/67 patients (13.4%) in the placebo arm and 3/62 patients (4.8%) in the BDP arm. Infection contributed to the deaths of 9/67 patients (13.4%) in the placebo arm and 3/62 (4.8%) in the BDP arm. Acute or chronic GVHD was the proximate cause of death in 3/67 patients (4.5%) in the placebo arm and in 1/62 (1.6%) in the BDP arm.
A retrospective analysis of survival at 200 days post-transplant in the supportive Phase 2 clinical trial showed consistent response rates with the pivotal Phase 3 trial; three patients (10%) who had been randomized to orBec® had died, compared with six deaths (21%) among patients who had been randomized to placebo, leading to a reduced hazard of day-200 mortality, although not statistically significantly different. Detailed analysis of the likely proximate cause of death showed that mortality with infection or with relapse of underlying malignancy were both reduced in the same proportion after treatment with orBec® compared to placebo. By transplant day-200, relapse of hematologic malignancy had contributed to the deaths of 1 of 31 patients (3%) in the orBec® arm and 4 of 29 patients (14%) in the placebo arm. Infection contributed to the deaths of 2 of 31 patients (6%) in the orBec® arm and 5 of 29 patients (17%) in the placebo arm.
Safety and Adverse Events
The frequencies of severe adverse events, adverse events related to study drug, and adverse events resulting in study drug discontinuation were all comparable to that of the placebo group in both trials. Patients who remained on orBec® until Day 50 in the pivotal study had a higher likelihood of having biochemical evidence of abnormal HPA function compared to patients on placebo.
Commenting on the clinical utility and safety profile of orBec®, Dr. Hockenbery stated, "Two randomized trials have shown that orBec® prevents relapses of acute GI GVHD after accelerated withdrawal of prednisone therapy. The effect is durable even following discontinuation of orBec®. Both trials showed a consistent survival benefit of orBec®, demonstrating that the ability to reduce systemic steroid exposure while maintaining remission of GVHD is associated with better clinical outcomes. We hypothesize that topical therapy with orBec® improved survival by limiting GVHD-related gastrointestinal epithelial injury, preserving the mucosal barrier, reducing the need for prolonged systemic glucocorticoid treatment, and reducing the frequency of life-threatening infections."
orBec® Submitted for Approval
All of the data published today were included in the Company's New Drug Application ("NDA") filed with the U.S. Food and Drug Application ("FDA"), and the Marketing Authorization Application ("MAA") filed with the European Medicines Evaluation Agency ("EMEA"). Both health authorities have accepted the filings for review. The FDA has said it will respond to DOR's NDA by July 21, 2007 under PDUFA guidelines.
About GI GVHD
GVHD is a debilitating and painful disease. It is a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's body -- most frequently the gut, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.
orBec® is a two-tablet system containing the highly-potent, topically-active corticosteroid beclomethasone dipropionate, and is designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects. Systemic immunosuppressive agents such as prednisone, which are the current standard treatments for GI GVHD, are associated with high mortality rates due to infection and debility. Further, these drugs have not been approved for treating GI GVHD in the European Union or in the U.S., but rather are used off-label as investigational therapies for this indication.
About Allogeneic Bone Marrow/Stem Stem Cell Transplantation (HSCT)
Allogeneic hematopoietic stem cell transplantation ("HSCT") is considered a potentially curative option for many leukemias as well as other forms of blood cancer. In an allogeneic HSCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. The curative potential of allogeneic HSCT is now partly attributed to the so-called graft-versus-leukemia ("GVL") or graft-versus-tumor ("GVT") effects of the newly transplanted donor cells to recognize and destroy malignant cells in the recipient patient.
The use of allogeneic HSCT has grown substantially over the last decade due to advances in human immunogenetics, the establishment of unrelated donor programs, the use of cord blood as a source of hematopoietic stem cells and the advent of non-myeloablative conditioning regimens ("mini-transplants") that avoid the side effects of high-dose chemotherapy. Based on the latest statistics available, it is estimated that there are more than 10,000 HSCT procedures annually in the U.S. and a comparable number in Europe. Estimates as to the current annual rate of increase in these procedures are as high as 20%. High rates of morbidity and mortality occur in this patient population. Clinical trials are also underway testing allogeneic HSCT for treatment of some metastatic solid tumors such as breast cancer, renal cell carcinoma, melanoma and ovarian cancer. Allogeneic transplants have also been used as curative therapy for several genetic disorders, including immunodeficiency syndromes, inborn errors of metabolism, thalassemia and sickle cell disease. The primary toxicity of allogeneic HSCT, however, is GVHD in which the newly transplanted donor cells damage cells in the recipient's gastrointestinal tract, liver and skin.
About orBec®
orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec®, if approved by the EMEA and the FDA, would be the first oral formulation of beclomethasone dipropionate ("BDP") available in the European Union and the United States, respectively. orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. BDP is a highly-potent, topically-active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the more distal portions of the GI tract.
In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec® also benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, which provide for 7 and 10 years of post-approval market exclusivity, respectively.
About DOR BioPharma, Inc.
Potp pancreatic data
The Gemzar registration trial was in 71 percent stage 4
disease.
48 percent had the probability of living six months. They had 1 PR and no CR
The talabostat study showed 10 out of 21
Lived 6 months and had 2 confirmed PRs and 1 CR in a patient with liver metastacies.
The Talabostat patient population was 100 perrcent stage 4. It is always difficult to compare study
results when you have different stage patients in the different trials.
Bottom line 10 out of 21 with six month survival. Almost a 10 percent RR (3 out of 33) in
a 100 percent stage 4 patient population is positive. They need more patients to report on but will be able to do this at ASCO.
This is why dewophile response below is wrong. The main problem with potp is that they didn't go public with an IPO window so the funds have always been short. The drug works or at least I think it does. I wouldn't mortgage the house betting on it but the risk reward is very good. Much better than Telk, which did their IPO during one of the IPO windows.
from dewophile
[anyone know off the top of their head what the 6 month survival is on SOC for Stage IV Pancreatic?]
looks like median survival is more or less 6 months, so the 48% 6 months survival in this small study seems unremarkable
http://www.cancer.gov/cancertopics/pdq/treatment/pancreatic/HealthProfessional/page9
http://www.gemzar.com/hcp/gemzar_pancreatic.jsp?reqNavId=6.3
osir is a good comp for dorb
They will be addressing the same market. Orbec would be able to be used with Oris's product.
The interesting thing about osir is they put out a P/R from a presentation where they had very good survival at 120 days. What they didn't report was that at 200 days the survival rate was only 75 percent, about the same as the standard of care group in the orbec phase 3 trial.
osir could be a short, even if the drug complete's phase 3 with statistical significance it may be priced for perfection.
dorb posted by tougher now on the ymb
The Market for orBec®
There are approximately 10,000 bone marrow and stem cell transplants in the U.S. each
year. The market potential for orBec for the treatment of GI GVHD is estimated to be
between 50 and 70 percent of these procedures. We have assumed $10,000 per course of
treatment for orBec® (actual pricing is obviously still to be determined). This equates to a
potential dollar market of between $50 million and $70 million. To put this in context,
transplant centers are usually reimbursed at a fixed rate of approximately $250,000 for
bone marrow and stem cell transplants. It is estimated that a single readmission to the
hospital can cost the institution between $14,000 and $50,000. These patients have a high
rate of readmission due to relapse of GI GVHD or leukemia. If these patients then become
terminal and enter critical care, the costs mount very quickly. In two separate randomized,
double-blinded, placebo-controlled trials, orBec has shown an approximately 67% reduction
in mortality as well as a significant reduction in GI GVHD relapse rates in the pivotal trial.
Several companies are attempting to develop technologies to treat GVHD by suppressing
the immune system. Companies such as Sangstat, Abgenix, and Protein Design Labs are
developing monoclonal antibodies to treat GVHD. Novartis, Medimmune and Ariad are
developing both gene therapy products and small molecules to treat GVHD. There are no
products currently being marketed to selectively treat GI GVHD.
GI GVHD is what ORBEC TARGETS. NO PRODUCTS CURRENTLY AVAIL ON MARKET FOR IT!-thats a key sentence in the above description of ORBECS potential
http://www.wallstreetadvisor.com/DORB_Re...
http://biz.yahoo.com/iw/061121/0187094.h...
"There are more than 10,000 allogeneic stem cell transplants in the U.S. each year," added Dr. Schaber. "It is estimated that allogeneic transplants will increase by as much as 20% annually over the next several years, with cord-blood and reduced intensity conditioning regimens, known as 'mini-transplants,' in the elderly fueling much of this growth. Unfortunately, more than half of these patients will go on to develop GI GVHD that requires treatment. We believe that orBec®, if approved, will potentially provide transplant physicians with an effective and much-needed tool to treat their GI GVHD patients and to improve survival. If approved, it is our intention to commercialize orBec® on our own in the United States, and to partner it in Europe and the rest of the world."
Sentiment : Strong Buy
hey red,
happy new year, I mentioned here months ago that the company would have to raise money and it probably wouldn't be on favorable terms. There was a best favored nations status in the last deal so those buyers get the cheaper price.
Sometimes if you think the drug is valuable it pays to get a large raise done so you have the money to find out.
I owned conjuchem at over a dollar because I liked the their once weekly glp-1 data. Then the did a raise of over a hundred million at 65 cents canadian which was over 35 cents below the closing price the prior day because the raise was so large. it sucked but i got into the deal because it also came with 5o percent warrant coverage.
conjuchem cjb.to now has over 300 fully diluted shares but if amlyn can have a market cap of over 4 billion dollars with over half of its value for the LAR then conjuchem is cheap at 90 cents canadian, because their data looks better but is about a year behind in development.
sometimes you need to bite the bullet if you believe in the technology. I don't know anything about adh's technology
Dor Biopharma Cell Thereapeutics
you take one crap company and merge it into another crap company and somehow it turns out 'Magically Delicious"
before you call dor biopharma a crap company look at the unmet medical need and the data from their phase 3 trial
believe me, they don't want ctic stock as consideration but this will get interest in the company now so I am glad the offer was made.
My hope is they raise some money and keep the drug for themselves in the US and just license off the European markets.
What people don't realize is that there are currently 8-10,000 bone stem cell transplants a year. The major reason there aren't more is that there aren't enough matched donors to supply the stem cells for transplant and if you use mismatched donors the death rate is very high
In the Dor phase 3 trial only one of 16 patients with mismatched donors died at 200 days, whereas in the standard of care group I think 12 of 16 mismatched donor transplant recipients died.
If the drug gets approved it will also increase the market size because mismatched donor transplants will be available.
How do you like that for a crappy company
I believe this puts dor in play
Sigma tau has an option until march 1st for the european rights
dor can't negotiate with anyone else until that lapses. that does not stop other offers and it also doesn't mean they need to accept sigma tau's offer
Anormed was trading at 4 dollars until genz offered 8.55 a share
millenium then offered 12 and finally genz bought them for 13.50 or 580 million.
dor won't go for anywhere near that amount but I don't think a dollar a share is out of the question, and from a better company than ctic
Scientists See Potential In Amniotic Stem Cells
They Are Highly Versatile And Readily Available
I am not sure if this was already posted
By Rick Weiss
Washington Post Staff Writer
Monday, January 8, 2007; A01
A type of cell that floats freely in the amniotic fluid of pregnant women has been found to have many of the same traits as embryonic stem cells, including an ability to grow into brain, muscle and other tissues that could be used to treat a variety of diseases, scientists reported yesterday.
The cells, shed by the developing fetus and easily retrieved during routine prenatal testing, are easier to maintain in laboratory dishes than embryonic stem cells -- the highly versatile cells that come from destroyed human embryos and are at the center of a heated congressional debate that will resume this week.
Moreover, because the cells are a genetic match to the developing fetus, tissues grown from them in the laboratory will not be rejected if they are used to treat birth defects in that newborn, researchers said. Alternatively, the cells could be frozen, providing a personalized tissue bank for use later in life.
The new cells are adding credence to an emerging consensus among experts that the popular distinction between embryonic and "adult" stem cells -- those isolated from adult bone marrow and other organs -- is artificial.
Increasingly, it appears there is a continuum of stem cell types, ranging from the embryonic ones that can morph into virtually any kind of tissue but are difficult to tame, up to adult ones that can turn into a limited number of tissues but are relatively easy to control.
The newly analyzed fetal stem cells, scientists said, have many of the advantages of both.
"They grow fast, as fast as embryonic stem cells, and they show great pluripotentiality," meaning they can become many kinds of tissues, said study leader Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University School of Medicine in Winston-Salem, N.C. "But they remain stable for years without forming tumors," he added, something that embryonic cells are not very good at.
Atala and other scientists emphasized that they don't believe the cells will make embryonic stem cells irrelevant.
"There's not going to be one shoe that fits all," said Robert Lanza, scientific director at Advanced Cell Technology in Worcester, Mass. "We're going to have to see which ones are most useful for which clinical conditions."
George Daley, a Harvard stem cell researcher, echoed that sentiment. "They are not a replacement for embryonic stem cells," he said.
But in the past, even hints that non-embryonic cells might have medical potential similar to embryonic ones have complicated the political push to expand federal funding for the controversial field. And accordingly, opponents quickly pounced on the new results.
"This is wonderful news," said Richard Doerflinger, deputy director of pro-life activities at the U.S. Conference of Catholic Bishops, which opposes research that depends on embryo destruction. "It doesn't require harming anyone or destroying life at any stage."
Last year, President Bush vetoed a bill that would have allowed federal funding of research on stem cells from embryos discarded by fertility clinics. The newly Democratic Congress has promised to send the same or a similar bill to Bush's desk with even greater majorities early this term, with the House slated to vote on the matter this week.
The new work, described in yesterday's online edition of the journal Nature Biotechnology, shows that "amniotic fluid-derived stem cells" can be isolated as early as 10 weeks after conception from fluid extracted during tests widely done to detect birth defects.
In the laboratory, the amniotic cells can mature into all of the major types of cells, dividing at the impressive clip of once every 36 hours yet never showing signs of aging and never becoming tumors -- even after living for more than two years in the lab.
With co-workers from Wake Forest and from Children's Hospital in Boston, Atala coaxed the cells to become brain cells and injected them into the skulls of mice with diseased brains. The new cells filled in diseased areas and appeared to make new connections with nearby healthy neurons.
When coaxed to become bone cells and seeded onto a gelatin scaffold that was then implanted in a mouse, the cells calcified and turned into dense, healthy bone.
Under other conditions they became muscle, fat, blood vessel and liver cells.
Atala said that if 100,000 women donated their amniotic cells to a bank, that would provide enough cells of sufficient genetic diversity to provide immunologically compatible tissues for virtually everyone in the United States. With more than 4 million U.S. births a year, it would not take long to collect that many specimens, he said -- especially because the cells can be found not only in amniotic fluid but also in the placenta, which is discarded after birth.
The rights to certain patent claims relating to the cells have been licensed to Plureon Corp. of Winston-Salem, a privately held company on whose board of directors Atala sits.
Although several stem cell experts applauded the work, some questioned the novelty of the newly described cells. Similar cells have been under study for years with little fanfare, they noted. And though Atala's careful characterization of them is better than any previously done, they said, it is not clear that his cells are truly different than ones others have in hand.
At Children's Hospital in Boston, for example, Dario Fauza, a pediatric surgeon, has been cultivating similar cells and getting them to grow into cartilage, which he has used to repair defective windpipes in newborn sheep. He has also grown the cells into tendon tissue that was used to repair defective diaphragms in sheep.
Fauza is seeking Food and Drug Administration permission to try the method in children diagnosed with birth defects while in the womb. He hopes to grow replacement tissues from their own amniotic cells and use those tissues to repair their defects after birth.
"Typically, you don't do anything until the child is born, and then you are scrambling to fix it," Fauza said. "Why not take out some amniotic fluid, which we do routinely anyway, and engineer a tissue in parallel during the remainder of gestation so he or she will have a tissue by the time he or she is born?"
Ipsen gets FDA nod for Somatuline Autogel product
headline from reuters....don't they realize that accepting a filing is not the same as giving its nod to a drug. The person that allows these headlines should be fired
Mon Jan 15, 2007 2:15am ET
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IPN (Ipsen )
Last: €36.01
Change: +0.91 (+2.59%)
Revenue (ttm): M
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Market Cap: M
Time: 10:41am ET
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PARIS, Jan 15 (Reuters) - French biotechnology group Ipsen (IPN.PA: Quote, Profile , Research) said on Monday that the U.S. Food & Drug Administration (FDA) had accepted the filing of a new drug application for its Somatuline Autogel product.
Somatuline Autogel is used to treat a symptom called acromegaly, which is a disorder caused by the overproduction of growth hormones secondary to a benign tumour of the anterior pituitary gland.
The product has already had marketing approval in over 50 countries.
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I don't own alt or really follow it anymore
I just saw the financing and couldn't believe it.
I know rodman doesn't have the best reputation but even they should be embarrassed to be involved in this
alteon does this mean that if they don't raise 20 million by may 31st that this fund can excersize warrants for a penny and short them all the way down from 15 cents and still be owed all that other money. and have the
Alteon Announces Receipt of $3 Million in Private Secured Convertible Debt and Warrant Financing
Friday January 12, 10:55 am ET
PARSIPPANY, N.J., Jan. 12, 2007 (PRIME NEWSWIRE) -- Alteon Inc. (AMEX:ALT - News) announced today that it has entered into a definitive agreement with institutional investors that are experienced in the biotechnology industry under which the Company has issued $3 million principal amount of its 8% convertible secured notes and warrants to purchase 25,734,453 shares of its common stock.
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The notes will automatically be converted into any security that is issued by Alteon to the investors and other potential investors in connection with a proposed private preferred stock and warrant financing of up to $20 million that is currently being negotiated. The closing of any such additional financing, which the Company anticipates will be done at a discount from the market price, will be subject to stockholder approval. At the election of the investor, the notes may also be converted into any other security that is issued by Alteon as part of a financing completed with any other investors prior to May 31, 2007. If the notes have not been converted by May 31, 2007, Alteon will be required to repay the investor $4 million on such date in satisfaction of its obligations under the notes. In addition, if such conversion has not occurred by May 31, 2007, Alteon will pay the investors a fee of 15% of amounts received as part of any financing, sale or licensing transactions that are consummated by the Company prior to June 30, 2008, subject to a cap on such fee of $2 million. The notes may be repaid either in cash or in shares of Alteon's common stock, at the investors' option.
The notes are secured by a first priority security interest in all of Alteon's assets. The common stock purchase warrants will be exercisable starting on May 31, 2007 for a period of five years from January 11, 2007 at an exercise price of $0.01 per share, unless the notes are converted as described above, in which case the warrants will expire on the date of conversion.
Rodman and Renshaw served as placement agent for the transaction. Alteon intends to use the proceeds of the financing to fund the Company's operations and ongoing clinical and preclinical development programs.
The securities described in this announcement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This announcement is neither an offer to sell nor a solicitation to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.
About Alteon
Alteon is a product-based biopharmaceutical company engaged in the development of small molecule drugs to treat and prevent the inflammatory aspects of cardiovascular disease and diabetes. The Company has identified several promising product candidates that it believes represent novel approaches to some of the largest pharmaceutical markets.
Alagebrium, a product of Alteon's drug discovery and development program, is being developed for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, which represents a sizeable human safety database.
The Company's portfolio also includes orally bioavailable, organoselenium mimics of glutathione peroxidase that metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. Alteon's lead compound for that program, ALT-2074, is in Phase 2 clinical trials. The Company also has rights to a diagnostic assay that identifies a large subset of diabetic patients at highest risk for cardiovascular complications, because of a defect in oxidized lipid metabolism that results in increased cardiovascular inflammation. For more detailed information about Alteon's research and development, please visit Alteon's website at http://www.alteon.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risk that the potential preferred stock financing described in this press release will not be completed in a timely manner or at all, and other risks identified in Alteon's filings with the Securities and Exchange Commission. Further information on risks faced by Alteon are detailed under the caption ``Risk Factors'' in Alteon's Annual Report on Form 10-K for the year ended December 31, 2005 and in its subsequent Quarterly Reports on Form 10-Q. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Alteon undertakes no obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contact:
Alteon Inc.
Investor Relations
201-818-5537
rpbif
Response has the most accurate troponin test by far. they couldn't sell much of it because they didn't have a bnp test and these tests are sold as a panel. They couldn't compete.
Nanogen has an inferior product. Rpbif's problem is that there are many players out there so they have to differentiate their product which I think they will do. They are the only POC product that correlates to the slower more expensive lab analysers
Bayer and Onyx Announce Pivotal Nexavar(R) Kidney Cancer Study Published in New England Journal of Medicine
Wednesday January 10, 5:24 pm ET
Nexavar Doubled Progression-Free Survival in Largest Advanced Kidney Cancer
Trial
WEST HAVEN, Conn. and EMERYVILLE, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that the New England Journal of Medicine has published their pivotal Phase III trial demonstrating that Nexavar® (sorafenib) tablets doubled median progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC), or kidney cancer. The data, as assessed by independent radiologic review, are from the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) -- the largest randomized controlled trial ever conducted in advanced RCC.
(Photo: http://www.newscom.com/cgi-bin/prnh/20070110/NYW150 )
"Historically, patients with kidney cancer have had limited treatment options and there has been a particularly critical need for new therapies to help patients with advanced disease," said co-principal investigator Ronald Bukowski, M.D., Director of the Experimental Therapeutics Program of The Cleveland Clinic Taussig Cancer Center in Cleveland, OH. "This landmark study demonstrated the efficacy, tolerability and clinical benefit of Nexavar, which has rapidly become a valuable weapon against this devastating disease."
Based on these data, Nexavar was granted U.S. Food and Drug Administration (FDA) approval for the treatment of patients with advanced RCC, or kidney cancer, on December 20, 2005. Since then, Nexavar has been approved in nearly 50 countries.
"Nexavar was the first new drug approved for patients with advanced kidney cancer in over a decade," said Bill Bro, President and Chief Executive Officer of the Kidney Cancer Association (KCA). "With the advent of targeted therapies such as Nexavar, there has been remarkable change -- patients are experiencing improved outcomes without the toxic effects traditionally associated with chemotherapy."
Phase III Summary More than 900 patients with advanced RCC were randomized one-to-one to receive either 400 mg Nexavar or placebo orally twice a day in this randomized, multi-national, placebo-controlled Phase III study. The endpoints of the study are overall survival (OS), PFS, overall response rate and safety. PFS measures the length of time that a patient lives without evident tumor growth or death.
PFS doubled to a median of 5.5 months in patients receiving Nexavar compared to 2.8 months for patients receiving placebo (p < 0.001). This represented a 56% reduction in the risk of progression (hazard ratio 0.44; 95% CI, 0.35 to 0.55) for patients on Nexavar versus placebo. All patient subgroups examined benefited regardless of performance status or risk group, including patients who had not received conventional treatment with biologics, such as interleukin-2 or interferon-alpha.
In May 2005, due to the clinical and statistical significance of the PFS data, the companies unblinded the trial and announced that patients who were receiving placebo were allowed to "cross over" to drug treatment. The first OS analysis conducted immediately before cross-over found a 39% improvement in OS for Nexavar patients (hazard ratio 0.72, p=0.018). A further OS analysis performed six months following cross over was based on 367 survival events (patient deaths) that had occurred by November 30, 2005. Results showed a continued trend toward improved survival, with a 23% reduction in the risk of death (19.3 months for Nexavar patients versus 15.9 months for placebo patients; hazard ratio 0.77, p=0.02), despite the fact that nearly half of placebo patients had "crossed over" to Nexavar. Patients continue to be followed and a final survival analysis will be available in the first half of 2007. The Phase III data published in NEJM have previously been communicated at international scientific congresses.
About Nexavar
Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in nearly 50 countries, including the United States and in the European Union, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated by the companies, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including adjuvant RCC, advanced liver cancer, metastatic melanoma, non-small cell lung cancer and breast cancer.
About Kidney Cancer
Renal cell carcinoma is the most common form of kidney cancer. Nearly 208,000 people worldwide are diagnosed (about 37,000 Americans) with renal cell carcinoma each year and more than 102,000 of them die (about 12,000 Americans) from the disease annually. For more information on renal cell carcinoma, visit the Kidney Cancer Association (KCA) web site at: http://www.curekidneycancer.org.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For U.S. Nexavar prescribing information, visit http://www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at: http://www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33,800 people worldwide in 2005.
The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Bayer HealthCare Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.
Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission under the heading " Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
NEXAVAR® is a registered trademark of Bayer AG, Germany.
--------------------------------------------------------------------------------
Source: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.
I wasn't telling you about Pipex here
I sent you a link to tm which may actually work for IPF and you seemed interested in Intermune for that indication. They could actually get tm approved for Wilson's way before intermune gets their drug approved and tm may work better
I know if I knew someone with it I would try to get the drug.
if you are interested in pulmonary fibrosis check this out
http://cat.inist.fr/?aModele=afficheN&cpsidt=16073786
David, could you elaborate on the volume of analysts present at yesterdays RPRX analyst meeting in NYC (if you were there)? It sounded like a good crowd from what I heard in the background prior to the start.
I was there. The volume of the analysts was very impressive.
I am sure that some of them weighed 300 hundred pounds or more.
The trial did not meet its primary endpoint, but the results may be good enough to move forward with the program pending results from a similar Roche-sponsored trial," wrote Kantor, in his Jan. 5 note.
Big Pharma trounces Big Biotech in 2006
Endpoints are the goals by which a clinical trial either succeeds or fails, and the trials of course determine whether a drug will enter the market. Kantor told CNNMoney.com that he hadn't seen the data, and had made his determination based on a conversation with a Genentech employee, and from what he was able to glean from the press release.
"I believe that they did not hit their primary endpoint," said Kantor to CNNMoney.com. "I asked the company that, and they confirmed that with me."
But Pellegrino of Genentech insisted to CNNMoney.com that the pertuzumab study had made its endpoint. She also said she hadn't discussed the matter with Kantor and had not seen his note.
"The endpoint of the study was to estimate what the improvement in progression-free survival would be," said Pellegrino. "I don't think it's accurate to say it missed its endpoint. We met the endpoint of estimating progression-free survival."
Kantor will now be on dna's sh*tlist
Fda only approved 18 drugs in 2006
story from bloomberg
http://player.clipsyndicate.com/player/play_url?url=http://www.clipsyndicate.com/clipsyndicate/play_...
This column marks Adam Feuerstein's return to TheStreet.com. Feuerstein is an award-winning reporter who worked at TheStreet.com before a two-year stint covering biotech at a New York-based investment firm. We're thrilled to welcome him back.
http://www.thestreet.com/newsanalysis/biotech/10330780.html
I guess he wasn't as smart when it actually came to managing a portfolio.
David, could you elaborate on the volume of analysts present at yesterdays RPRX analyst meeting in NYC (if you were there)? It sounded like a good crowd from what I heard in the background prior to the start.
I had gas, did you hear that?
September 2003 raised copper levels
From University of Michigan Health System
Drug developed for rare disease may help millions more as treatment for cancer, autoimmune diseases
UMHS researchers leading dozens of studies on anti-angiogenesis drug
ANN ARBOR, Mich. – An anti-angiogenesis drug developed at the University of Michigan is showing promise in studies of three different disease families, including multiple forms of cancer. The drug, tetrathiomolybdate or TM, essentially wages war against copper, which serves to choke off tumor growth, fibrosis and inflammation.
U-M researcher George Brewer, M.D., who developed the drug, will present his findings to date and report on ongoing basic and clinical TM research at the 226th American Chemical Society national meeting Sept. 10 in New York. Brewer's presentation will be part of a one-day symposium on medicinal inorganic chemistry.
TM began as a treatment for Wilson's disease, a rare genetic disease that causes toxic build-ups of copper. Recent phase III clinical data show TM is more effective than other treatments at reducing the disease's effects. Realizing the key role of copper in angiogenesis, Brewer and colleagues then began exploring treatments for cancer, including breast cancer, kidney cancer and liver cancer. Currently, TM is involved in nine phase II clinical studies related to cancer, with more planned.
But it doesn't end there. Brewer and colleagues are also looking into the effect of TM on inflammatory fibrosis diseases such as pulmonary fibrosis, cirrhosis, cystic fibrosis and psoriasis.
"TM has the potential to be a powerful tool in fighting a wide range of diseases. While it has literally saved the lives of young people with Wilson's disease, Wilson's is a rare disease. If early results in cancer and inflammatory diseases hold their promise through the next phase of trials, there's potential for this to impact a lot of people," says Brewer, Morton S. and Henrietta K. Sellner Emeritus Professor of Human Genetics at the University of Michigan Medical School.
Wilson's disease typically strikes young adults in their teens or early 20s. The condition causes copper to accumulate in the body at dangerous levels, and if left untreated can cause severe liver damage and neurological effects and eventually death.
Positive results of phase III clinical studies on TM in Wilson's disease were published last winter. Brewer is currently looking for a drug company to submit it for approval by the U.S. Food and Drug Administration as an orphan drug for treating Wilson's disease. Meanwhile, patients have come to UMHS from all over the world to receive treatment through the clinical trials protocol.
While the Wilson's treatment began to achieve success in the early 1990s, research at U-M and elsewhere started to uncover the role of copper in angiogenesis, or the formation of new blood vessels. This is a process that occurs normally in the body but becomes uncontrolled in cancerous cells. Researchers found copper was important to various molecules called growth factors that are necessary to the organizing process by which cells become part of new blood vessels.
That launched Brewer into a new direction with TM as an anti-angiogenesis drug. He began working with breast cancer researchers, particularly Sofia Merajver, M.D., at the U-M Comprehensive Cancer Center. In 2000, they published promising results of a pilot clinical trial. From there, many more trials have begun, some of which are now reporting positive early results.
"TM inhibits angiogenesis and growth factor by reducing the copper," Brewer says. "Essentially, the drug blocks the key signaling pathway, preventing tumor cells from sending signals to form new blood vessels, which thereby prevents or slows the cancer from growing or spreading."
TM is made up of the elements sulfur and molybdenum. These combined elements latch on to copper in the blood and to a protein called albumin. The three-part complex formed by this bonding is then eliminated by the body. For Wilson's patients, this brings high copper levels down to normal ranges. In cancer, it creates a mild copper deficiency, which is what inhibits the tumor growth.
And that led Brewer to consider whether TM would affect fibrotic diseases. In much the same way that copper deficiency inhibits the angiogenic effect in tumor cells, Brewer found it also inhibits transforming growth factor beta, or TGF-beta, the response that triggers the connective tissue growth. Additionally, studies suggest TM inhibits TNF-alpha, or tumor necrosis factor alpha, the response that triggers inflammation.
"When an organ is injured, the body overreacts, and doesn't properly regulate. This causes inflammation and fibrosis to over-respond, producing diseases. With TM, we're able to shut down the excessive inflammation and excessive fibrosis that causes much of the disease after an organ is injured," Brewer says.
TNF-alpha antibodies, sold as the commercial drugs Enbrel and Remicade, have been used in new treatments for autoimmune diseases such as rheumatoid arthritis and Crohn's disease. But this therapy requires regular injections of the antibodies. The next question on Brewer's plate is whether TM can do the job even easier.
"We have an oral pill that's shown to inhibit TNF-alpha in mice. The concept is that for whatever diseases these antibodies therapeutically benefit, TM should be tried," Brewer says. Studies are either beginning or in the planning stages for several autoimmune diseases.
One of the advantages to TM is that it carries few side effects. Studies to date show the primary side effect is copper deficiency from overtreating. This causes anemia, but is corrected by lowering the dose or stopping the TM treatment. In Wilson's patients, there is also a risk of liver damage. That also is alleviated by a drug holiday.
Some of the TM trials that are currently in place or being planned at UMHS and collaborating institutions include breast cancer, kidney cancer, liver cancer, esophageal cancer, mesothelioma, idiopathic pulmonary fibrosis, scleroderma, primary biliary cirrhosis and psoriasis.
Additional Contact:
Kara Gavin
kegavin@umich.edu
734-764-2220
For more information on TM research at the University of Michigan Health System, call the Cancer AnswerLine at 800-865-1125 or visit www.cancer.med.umich.edu/contact.htm.
medicure
please see my post 40109
mcu medicure
The tradeoff between some dilution vs. losing most of the revenue to the partner was probably the right one this time.
(Of course when I invested initially I hoped for quick partnering and profit. That did not happen, But the risk/reward prospect is a heck of lot better now.)
I believe you are completely wrong. The company raised the money to lift the lid on the stock which is caused by people not buying the stock because they started the phase 3 without having the money to finish it. The next question was people saying that since they didn't have the money to finish the trial that the pharma partners would play hardball.
In my opinion the company will partner the drug to de risk the process. If they spend all of their money to finish the phase 3 and it fails even though the phase 2 worked the stock price will get killed and they wouldn't have the money for 4232.
The will partner mc-1 and I believe they will get an upfront payment of 25- 50 million for it and the partner will pay for the trials. they will also be able to get some kind of co promote deal using their existing salse force.
This will also allow them to start their phase 3 trials in 4232 which is probably a bigger market.
how great is that.
I make sure all of my cows are prion free
The tough part is finding cows that produce chocolate milk
partners
Nuvello recently recieved 160 million up front from Bayer. I have to think that Bayer did tons of dd before making that investment.
Third party validation may not be as important as you would think it would be
Diabetes article from the NY times
shows why compliance is so important in saving money and keeping people healthy
December 30, 2006
New Job Title for Druggists: Diabetes Coach
By IAN URBINA
ASHEVILLE, N.C. -- In an office behind the Hershey's candy rack at a Kerr Drug here, Stuart Rohrbaugh shifts in his chair as his pharmacist stares at a dangerously high blood sugar reading from last month.
"I think that was the day a buddy of mine brought over his home-brew beer," stammers Mr. Rohrbaugh, whose diabetes was diagnosed six years ago.
Silently, the pharmacist lifts her eyes, sending Mr. Rohrbaugh's gaze to the floor.
"I know, I know," he says.
Mr. Rohrbaugh, 37, learned relatively late in life that he had Type 1 diabetes, a malfunction of the immune system that usually surfaces in childhood. There are hundreds in Asheville with that type, and even more with the more prevalent Type 2, which often hits as a consequence of obesity or age.
And so in this town of 75,000, where people like to use sugar in their coffee and in their iced tea, and as a term of endearment, Mr. Rohrbaugh and the others face the formidable challenge of either managing their diabetes or suffering its potential ravages: blindness, organ failure, stroke.
In trying to meet that challenge, the kind of polite browbeating that Mr. Rohrbaugh faced at his local pharmacy seems to be paying off.
For the past 10 years, the city of Asheville has given free diabetes medicines and supplies to municipal workers who have the disease if they agree to monthly counseling from specially trained pharmacists. The results, city officials say, have been dramatic: Within months of enrolling in the program, almost twice as many have their blood sugar levels under control. In addition, the city's health plan has saved more than $2,000 in medical costs per patient each year.
There are at least 21 million diabetics in the United States, and health officials have begun to despair of combating the disease because it involves getting people to do something much more difficult than taking their medicine or having surgery: altering their daily behavior, like their eating and exercise habits.
But amid this gloom, Asheville's public health experiment is something of a ray of hope, an example, however modest, of the kind of house-to-house, block-to-block battle that can win results and save lives in the face of a disease that has resisted quick-fix solutions.
Indeed, in recent years, about 40 other employers across the country -- private companies or municipalities -- have adopted versions of the program.
"We get a four-to-one return on investment," said Barry Bunting, pharmacy director at Mission Hospitals, which runs the program in Asheville for about 450 city and hospital employees. For every dollar spent on medicines or counseling about diet, exercise and lifestyle, he said, the city saves $4 by preventing emergency room visits, dialysis, amputations or other common complications of diabetes.
During the first five years of the program, participants took an average of six sick days from work a year, half the number of previous years. Within three years of enrolling in the program, patients had halved their chances of going blind or needing dialysis or an amputation, a founder of the program said.
"When you have to answer to someone each month, you think twice before eating what you shouldn't," said George Ledford, 69, who joined the program five years ago.
The fifth deadliest disease in the nation, diabetes costs more than $130 billion per year in medical expenses and lost productivity in the workplace. While there is no cure, patients can delay or prevent complications by using medications properly and adjusting their diet and exercise routines.
But the efforts to help people change their lifestyles are complicated by a health care system in which insurers typically do not reimburse doctors for the kinds of counseling and monitoring that might keep patients on track.
So the Asheville experiment has enlisted pharmacists in its model. They serve as coach, clinician and cheerleader for patients, and they earn a fee for each session.
"Once you have a sense of what motivates them, you set little goals each visit and then build on them," said Dana K. Arrington, a clinical pharmacist at Kerr Drug who sees at least one diabetes patient a day.
"This month, get on the treadmill once a week for 15 minutes. Next month, we write down each time you take your pills. Then switch from whole to skim milk. It's a slow process if you want it to stick."
While diabetics have often shown significant improvements in controlling their blood sugar soon after taking diabetes education classes, they typically relapse within three months, according to a study released in March 2003 by the Journal of the American Pharmaceutical Association. The report was co-written by Carole W. Cranor, a pharmacoeconomist who was then at the University of North Carolina, Chapel Hill.
What makes the Asheville Project unusual, the study found, is that at the end of the first year of the program, half the participants had their blood sugar under control. That number increased to two-thirds of the original group at the end of the program's third year.
"Asheville had unusually long-term successes because of the distinct role played by pharmacists, who have at least five years of academic training and who are more rooted and accessible in communities than doctors," said Ms. Cranor, who is now a clinical pharmacist at Dorothea Dix Hospital in Raleigh, N.C.
Aside from Asheville's successes, the popularity of the program is being driven by pharmaceutical companies.
GlaxoSmithKline and Sanofi-Aventis, which make diabetes drugs, have jointly given about a million dollars in the past five years to the American Pharmacists Association Foundation, a nonprofit research group, to help promote and replicate the program, said Dan Garrett, one of the founders of the Asheville Project and a director at the foundation.
Diabetics frequently fail to take their medications consistently, studies show, so these drugmakers stand to profit from better patient compliance. None of the employers or cities that adopt the program are obligated to buy from these companies, though.
The frequency of consultations is the reason the Asheville Project has shown such long-term benefits, Mr. Garrett said.
For patients struggling to adjust their daily habits, it is the little questions -- those too small and too numerous to justify an appointment with a doctor--that make the disease so difficult to manage and pharmacists' involvement so invaluable, patients said.
When Mr. Ledford kept getting sores on his feet, a common diabetes complication, his pharmacist ventured into the aisles to help him find a lotion that worked. When Mr. Ledford's blood sugar levels spiked mysteriously, the pharmacist questioned him about any changes in his routine. "The new cup I was using for my cornflakes was the wrong size," recounted Mr. Ledford, explaining that this mistake in figuring his carbohydrate consumption was throwing off his insulin dosage calculations.
Despite his occasional lapses, Mr. Rohrbaugh said that without frequent feedback from his pharmacist and the program's nutritionist, he would never have been able to learn how to count his carbohydrates, drop the necessary 20 pounds and administer his insulin. "I also was struggling to afford it all," said Mr. Rohrbaugh, a worker in city planning who was paying more than $300 per month for medicines and supplies before joining the program two years ago.
John Miall, one of the founders of the Asheville program, who recently retired as the city's director of risk management, said that within its first year the average annual health care cost for diabetic employees dropped to $3,554 from $6,127.
"Do the math," he said. "If just one employee is kept off dialysis, that is a $100,000 net savings for the year. That pays for a heck of a lot of preventative medicine and supplies."
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new investors from the recent financing
remember there was no discount and warrant coverage was only 20 percent
Optimum Small Cap Growth 444,084 444,084 0.37%
Wanger US Smaller Companies 1,776,120 1,776,120 1.48%
Wanger US Small Cap 4,428,360 4,428,360 3.69%
Columbia Acorn USA 4,428,360 4,428,360 3.69%
Federated Kaufmann Small Cap Fund, a Portfolio of Equity Funds 1,206,332 1,206,332 1.00%
American Skandia Trust Federated Aggressive Growth Portfolio 639,822 639,822 0.53%
Nite Capital LP 461,538 846,154 0.38%
ProMed Partners, L.P. 304,632 304,632 0.25%
ProMed Partners II, L.P. 14,442 14,442 0.01%
ProMed Offshore Fund, Ltd. 50,166 50,166 0.04%
ProMed Offshore Fund II, Ltd. 1,015,380 1,015,380 0.85%
Rockmore Investment Master Fund Limited 461,538 461,538 0.38%
Sigma Capital Associates, LLC(3) 1,200,000 1,400,000 1.17%
WHI Growth Fund Q.P., L.P. 1,846,152 1846,152 1.54%
Panacea Fund, LLC 461,544 561,544 0.47%
Monsun AS 600,000 0 0%
Lars H. Hoie 4,569,182 4,769,182 3.97%
Excellent buy and hold funds invested in the Medicure financing
These are not your typical funds that invest in pipes of one dollar stocks. This is long term money. The deal was priced at 1.30 which is where the stock had been trading for about a month so there was no discount. the warrant coverage was only 20%
Optimum Small Cap Growth 444,084 444,084 0.37%
Wanger US Smaller Companies 1,776,120 1,776,120 1.48%
Wanger US Small Cap 4,428,360 4,428,360 3.69%
Columbia Acorn USA 4,428,360 4,428,360 3.69%
Federated Kaufmann Small Cap Fund, a Portfolio of Equity Funds 1,206,332 1,206,332 1.00%
American Skandia Trust Federated Aggressive Growth Portfolio 639,822 639,822 0.53%
Nite Capital LP 461,538 846,154 0.38%
ProMed Partners, L.P. 304,632 304,632 0.25%
ProMed Partners II, L.P. 14,442 14,442 0.01%
ProMed Offshore Fund, Ltd. 50,166 50,166 0.04%
ProMed Offshore Fund II, Ltd. 1,015,380 1,015,380 0.85%
Rockmore Investment Master Fund Limited 461,538 461,538 0.38%
Sigma Capital Associates, LLC(3) 1,200,000 1,400,000 1.17%
WHI Growth Fund Q.P., L.P. 1,846,152 1846,152 1.54%
Panacea Fund, LLC 461,544 561,544 0.47%
Monsun AS 600,000 0 0%
Lars H. Hoie 4,569,182 4,769,182 3.97%
regn overvaluation
on a valuation basis you are right that regn is overvalued. the problem is that large biotech and pharma have been paying sky high valuations for early stage projects and regn already has a good deal with sanofi on the vegf trap and they might just buy them out
a short into the scenario would cause you a lot of pain
In 2001, the fund returned 35.9%, compared with a return for the Russell
2000 Index of 2.5%, while the Standard & Poor's 500 index was down 11.9%,
Hughes said. In 2003, the fund returned 355.2%, compared with 47.3% for the
Russell 2000 and 28.7% for the S&P 500, according to Hughes
This is an article that leaves out some very important info.
he currently runs 10 million, he was up 36 percent in 2001 and up 355.2 in 2003. if he is only running 10 million he must have wiped out his investors in 2002 and had a major hit where he went for the fences in 2003 and got lucky.
why didn't the writer give his returns for the last 5 years. Wouldn't that be important if we want to put any credence on his holdings.
Maybe I will contact her to write a story about me so I can pump my stocks.
I never said think equity and punk would come out with new targets next week
you had said that they didn't update their reports with the RPRX new data and I said they did