Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Successful Parkinson's Disease P-2 trial.
http://finance.yahoo.com/news/Neurologix-Announces-prnews-2701823243.html?x=0&.v=1
25 million share float, small biotech with gene therapy treatment for Parkinson's Disease. Cash appears down to 9 months, so some type of capital raise can be expected. Specifics of response in treatment arm apparently will have to await journal publication.
"Press Release Source: Neurologix, Inc. On Tuesday June 22, 2010, 8:30 am EDT"
Excerpt:
"FORT LEE, N.J., June 22 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC Bulletin Board:NRGX.ob - News), today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease (PD), NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period. The results also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene therapy or surgical procedure reported. Patients enrolled in the trial had moderate to advanced PD and were not adequately responsive to current therapies."
This study was for poorly responsive severe Parkinson's, but once results are validated in P-3, sky is the limit as there were no serious adverse events associated with treatment. Assuming the PR is accurate and the response is durable, this could be another DNDN or HGSI.
Successful Parkinson's Disease P-2 trial.
http://finance.yahoo.com/news/Neurologix-Announces-prnews-2701823243.html?x=0&.v=1
25 million share float, small biotech with gene therapy treatment for Parkinson's Disease. Cash appears down to 9 months, so some type of capital raise can be expected. Specifics of response in treatment arm apparently will have to await journal publication.
"Press Release Source: Neurologix, Inc. On Tuesday June 22, 2010, 8:30 am EDT"
Excerpt:
"FORT LEE, N.J., June 22 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC Bulletin Board:NRGX.ob - News), today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease (PD), NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period. The results also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene therapy or surgical procedure reported. Patients enrolled in the trial had moderate to advanced PD and were not adequately responsive to current therapies."
This study was for poorly responsive severe Parkinson's, but once results are validated in P-3, sky is the limit as there were no serious adverse events associated with treatment. Assuming the PR is accurate and the response is durable, this could be another DNDN or HGSI.
Successful Parkinson's Disease P-2 trial.
http://finance.yahoo.com/news/Neurologix-Announces-prnews-2701823243.html?x=0&.v=1
25 million share float, small biotech with gene therapy treatment for Parkinson's Disease. Cash appears down to 9 months, so some type of capital raise can be expected. Specifics of response in treatment arm apparently will have to await journal publication.
"Press Release Source: Neurologix, Inc. On Tuesday June 22, 2010, 8:30 am EDT"
Excerpt:
"FORT LEE, N.J., June 22 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC Bulletin Board:NRGX.ob - News), today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease (PD), NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period. The results also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene therapy or surgical procedure reported. Patients enrolled in the trial had moderate to advanced PD and were not adequately responsive to current therapies."
This study was for poorly responsive severe Parkinson's, but once results are validated in P-3, sky is the limit as there were no serious adverse events associated with treatment. Assuming the PR is accurate and the response is durable, this could be another DNDN or HGSI.
(1) "Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period."
(2) "The primary measure of efficacy in the study was the difference in off-medication motor scores between the treated and sham groups on the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor section), which has long been the standard for clinical assessment in Parkinson's disease. All subjects were evaluated at baseline as well as one, three and six months after undergoing surgery."
(3) The study investigators continue to further evaluate the detailed data and we look forward to its publication or presentation," said Clark A. Johnson, President and Chief Executive Officer of the Company. "Today's news is also important validation for our ongoing development of other technologies for neurological and psychiatric diseases, including our advanced pre-clinical program in epilepsy. Given these results, we would look to pursue a strategic transaction which will maximize value for the Company."
*Guess we just have to wait for the actual trial specifics regarding actual scores reflecting degree of improvement in the treatment arm...damn! My sister has PD, would love to have more specific information to pass on.
Congrats to all longs who got in before the spike. Company appears to have roughly 9 months worth of cash, so obviously a capital raise of some sort is in order. Luckily, with such a low float, NRGX could easily double the shares and still be in excellent shape share wise.
The results were evident within 1 month of treatment...amazing. Those here who are familiar with the P-1 trial...can you comment on durability and degree of response from that trial?
This relates to 'BiovaxID' produced by 'Biovest International (BVTI.OB)...apparently P-3 results due by May 1st..
What do you guys make of this?
Full article: http://jnci.oxfordjournals.org/cgi/content/full/98/18/1292
ABSTRACT
Background: Follicular lymphoma is considered incurable, although cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy can induce sequential remissions. A patient's second complete response is typically shorter than that patient's first complete response. Idiotype vaccines can elicit specific immune responses and molecular remissions in patients with follicular lymphoma. However, a clinical benefit has never been formally proven. Methods: Thirty-three consecutive follicular lymphoma patients in first relapse received six monthly cycles of CHOP-like chemotherapy. Patients who achieved a second complete response were vaccinated periodically for more than 2 years with autologous lymphoma-derived idiotype protein vaccine. Specific humoral and cellular responses were assessed, and patients were followed for disease recurrence. Statistical tests were two-sided. Results: Idiotype vaccine could be produced for 25 patients who had a second complete response. In 20 patients (80%), a humoral (13/20) and/or a cellular (18/20) idiotype-specific response was detected. The median duration of the second complete response has not been reached, but it exceeds 33 months (range = 20+ to 51+ months). None of the 20 responders relapsed while undergoing active vaccination. All responders with enough follow-up for the comparison to be made experienced a second complete response that was statistically significantly (P<.0001) longer than both their first complete response (18 of 18 patients) and than the median duration of a CHOP-induced second complete response, i.e., 13 months (20 of 20 patients). The five nonresponders all had a second complete response that was shorter (median = 10 months; range = 8–13 months) than their first complete response (median = 17 months; range = 10–39 months). Conclusions: Idiotypic vaccination induced a specific immune response in the majority of patients with follicular lymphoma. Specific immune response was associated with a dramatic and highly statistically significant increase in disease-free survival. This is the first formal demonstration of clinical benefit associated with the use of a human cancer vaccine.
--------------------------------------------------------------------------------
INTRODUCTION
Follicular lymphoma is an indolent B-cell malignancy for which no treatment has proved consistently curative (1). A number of conventional therapeutic options can induce relatively durable and sequential clinical complete responses in the vast majority of patients (2). However, second and subsequent responses tend to be progressively shorter than those achieved previously (2,3). In particular, most second complete responses obtained through standard chemotherapy (such as monthly treatment with the cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] regimen) last far less than 2 years, and the median duration is 13 months (4,5).
Several immunotherapeutic approaches to treatment of follicular lymphoma are currently under investigation (6). One is idiotype vaccination, which is based on the fact that the immunoglobulin on the surface of each patient's cancer cells contains a unique idiotype protein that can serve as a tumor-specific antigen (7). Over the past 15 years, idiotype vaccines have proved capable of eliciting both humoral (8–10) and cellular (9–10) idiotype- and tumor-specific responses in a variable percentage of patients with follicular lymphoma, particularly when used to consolidate a chemotherapy-induced first complete response (9,11). Some of these immune responses have been found to translate into molecular remissions, with circulating follicular lymphoma cells positive for Bcl-2/IgH rearrangements no longer detectable in patients in whom standard chemotherapy had achieved only clinical complete response (9,12). These results are consistent with those of a recent study that found that tumor-associated T-cell infiltration may influence clinical progression of follicular lymphoma (13). However, no formal proof of the clinical efficacy of idiotype vaccination has emerged (10). Evaluation of the efficacy of a customized patient-specific intervention is a challenge for conventional randomized trial methodology because it is difficult to make valid comparisons when the experimental intervention is unique to each patient (14).
In what is, to our knowledge, the largest and most homogeneous series of follicular lymphoma patients in first relapse treated with standard chemotherapy plus idiotypic vaccination, we investigated the association between the ability of a soluble protein idiotype vaccine to induce any idiotype- and/or tumor-specific immune response and the objective extension of relapse-free survival in follicular lymphoma patients. In addition to systematically monitoring both vaccine-induced immune responses and minimal residual disease in all vaccinated patients, we also compared the outcome of each patient's first and second complete response, so that each patient could effectively serve as his or her own matched control subject.
PATIENTS AND METHODS
Study Participants
Between October 1, 2001, and June 30, 2004, 33 consecutive patients with..... **full article link:
http://jnci.oxfordjournals.org/cgi/content/full/98/18/1292
Rancherho...
Would you mind granting some clarity regarding the recent revelations on I-Village post #189385.
What service were you supposed to offer DNDN which was worth $1,000 per day and 2.5 million DNDN stock options?
From I-Village...READ
just found this, makes one go hmmmmm
http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?symbol=DNDN
Need to go to bottom of page.
Key developments
Dendreon Corp. - Conference Presentation Call
03/18/2008
Dendreon Corp. - Conference Presentation Calls
U.S. District Court Rejects Class Members' Motion to Disqualify the Appointed Plaintiff as Lead Plaintiff in Suit Against Dendreon Corp
03/15/2008
The U.S. District Court for the Western District of Washington rejected a group of class members' motion to disqualify the plaintiff who was appointed as the lead plaintiff in a securities fraud class action, finding there was no evidence that the plaintiff's post-class period transactions rebutted the plaintiff's presumed adequacy as the lead plaintiff. Shareholders of Dendreon Corp. sued the company and its individual officers and directors alleging that the defendants made material misstatements and omissions related to the development of a drug known as Provenge. The shareholders made claims under §§ 10(b) and 20(a), and Rule 10b-5 of the Securities Exchange Act of 1934. The district court consolidated six individual suits into one action and appointed Kenneth McGuire, the individual with the largest financial interest in the litigation, as lead plaintiff and McGuire's counsel as the lead counsel. Another group of plaintiffs, collectively referred to as the Mountanos Group, moved to disqualify McGuire as the lead plaintiff because McGuire was an investor and former director of other unrelated biotech companies, creating the possibility that McGuire could have traded upon material nonpublic information. The district court rejected the argument. The Group moved for reconsideration of its motion based on the fact that McGuire entered into a consulting agreement with Dendreon to receive $1,000 per day and 2.5 million stock options in Dendreon after the class period.
***Who is McGuire???
You mean it likely wasn't a target for CEGE research because the technology and patents for that application (colon cancer)were held by Vaccinogen?
Yeah....you might be right, DD thinks the same thing.
Oh well...if this isn't picked up by the media, we will likely know they were simply trolling for suckers.
I will have to e-mail Huckman back and tell him it might be a scam.
If it hadn't come from JJ on I-Village I would have been more suspicious.
Best to all...
They claim FDA 'Fast Track' status.
From their site:
**In drug development, the proof is in the clinical trial…and OncoVAX® has demonstrated outstanding success in early trials. As a result, it has been granted SPA and Fast Track status by the FDA.
Vaccinogen’s OncoVAX® vaccine offers outstanding potential for commercial success, both in the short term and long term. It’s approval for commercial use in Switzerland will yield revenues over the next few months. A vast global market could unfold as soon as 2011, if FDA approval is achieved as expected.
**Vaccinogen has met many of the challenges of commercialization
Automated identity, potency & product characterization for a patient-specific tumor vaccine;
Vaccinogen has a patented sterile manufacturing process for patient-specific tumor vaccines, with the participation of the surgeon and the pathologist in the operating room;
Regulatory approval of commercial manufacturing facility in Holland by Dutch/Swiss Authorities; and
900/m2 facility has five class B manufacturing suites and two class C QC laboratories with a capacity to produce 2,500 OncoVAX® vaccines per year - a production amount sufficient to cover the pivotal Phase III clinical trial and the commercial sales of OncoVAX® in Switzerland.
That would be disappointing indeed...
This is from their website:
OncoVAX®:
Uses the patient’s own cancer cells to prevent recurrence of the disease, a pioneering approach that could redefine treatment protocols for Stage II cancer patients;
Has had more than 35 years and over $300 million (USD) in Research & Development since 1972;
Has been authorized for commercial use in Switzerland – and should be generating revenues there in a matter of months. Discussions are under way for Israel, Hungary and Singapore; and
Has completed a major Phase III clinical trial, and has been granted Fast Track status by the FDA for the treatment of Stage II colon cancer. The pivotal Phase III protocol has also received a Special Protocol Assessment by the FDA.
OncoVAX® is an active specific immunotherapy (ASI) that uses the patient’s own cancer cells to block the return of colon cancer following surgery. This patient-specific vaccine comprises sterile, metabolically active, irradiated, non-tumorigenic autologous tumor cells, with or without fresh frozen bacillus Calmette-Guerin bacterial as an adjuvant.
OncoVAX® is an active specific immunotherapy (ASI) that uses the patient’s own cancer cells to block the return of colon cancer following surgery. This is how OncoVAX® works. Following surgery to remove the Stage II color cancer, the tumor cells are processed in Vaccinogen’s facility in the Netherlands. The vaccine created in this process is injected into the patient’s skin in four doses over the first six months after the surgery. The injections produce a delayed-type hypersensitive response which indicates that the body’s own T-cells will respond to tumor antigens.
In short, the vaccine unleashes the body’s own immune system to fight a cancer that it otherwise would not have recognized.
OncoVAX® has successfully completed its first Phase III trial in Stage II colon cancer with outstanding, statistically significant, results:
25% improvement in 5-year median overall survival;
39% improvement in 5-year median recurrence-free survival; and
64% decrease in the number of patients whose disease progressed 18 months following treatment.
OncoVAX®’s clinical data is far more comprehensive than other immunotherapy products in development:
In five clinical studies, 383 patients have been treated with the vaccine; and
It has completed pharmacoeconomic analysis which indicated that its pricing is competitive with approved prescriptions in colon cancer treatment
OncoVAX vaccine approved by EMEA
This is a post by "japanjimmyd" which appeared on I-Village a few hours ago. Anyone familiar with this vaccine for stage-II colon cancer? Apparently written up in "Lancet"...any thoughts?
OncoVAX- 1st autologous vaccine for trt of colon cancer -EMEA approved and to be marketed in Switz June 2008
Vaccinogen's New Anti-Cancer Vaccine Commercially Available in Europe This Year
431 words
27 February 2008
11:25
PR Newswire (U.S.)
English
Copyright © 2008 PR Newswire Association LLC. All Rights Reserved.
FREDERICK, Md., Feb. 27 /PRNewswire/ -- Vaccinogen, Inc. announced that its new vaccine to block colon cancer from recurring will be commercially available in Europe starting June 2008.
"This makes OncoVAX(R) the world's first commercially viable vaccine for colon cancer," said Dr. Michael G. Hanna, Jr., Ph.D., Chairman & CEO of Vaccinogen. "It is the beginning of our worldwide strategy of profitable distribution. Questions of the feasibility of patient specific anti-cancer therapies have been raised and this new European initiative will obviate these issues."
Pro Vaccine AG, a leading Swiss-based pharmaceutical distributor, will begin distributing OncoVAX(R) throughout Switzerland starting with Zurich and Neuchatel by June 2008. "We are very excited about the prospects of offering OncoVAX(R) to Swiss and foreign patients," said Renato Duckeck, GM of Pro Vaccine.
Pharmacenter Hungary, a rapidly growing oncology company that commercializes a broad portfolio of oncology treatments, will begin distributing the vaccine in Hungary, Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia starting in the third quarter of 2008. Dr. Christian Galli, Director of Business Development of Pharmacenter Hungary noted, "We recognize the excellent opportunity OncoVAX(R) provides us and the growing population of colon cancer patients in Eastern Europe."
About OncoVAX(R)
OncoVAX(R) immunotherapy is based on a decades-long attempt by scientists to transform the body's immune response and its long-term memory to prevent the return of disease years after surgery. Such an approach has already been successful in preventing a number of infectious diseases.
Vaccinogen's scientists prepare a vaccine from the patient's own tumor and then administer the vaccine to the patient by three weekly injections one month after surgery. A fourth "booster" is administered six months later. OncoVAX(R) reduces recurrence and deaths by over 50%.
About Vaccinogen
Vaccinogen is a biopharmaceutical company that develops and commercializes cancer vaccines and other immunotherapeutic products -- Turning Cancer on Itself(TM). Based in Frederick, MD, the Company has a portfolio of product candidates for the treatment of cancer, infectious disease, autoimmune, anti- inflammatory diseases and fully human monoclonal antibodies in various stages of clinical development. The Company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for producing OncoVAX(R) vaccines.
http://www.vaccinogeninc.com
Contact:
Andrew L. Tussing
Vaccinogen
atussing@vaccinogeninc.com
301-668-8400
SOURCE Vaccinogen, Inc.
Anyone heard from Walldiver recently??
"If it were possible to short,...."
The sad thing is Dew, I think you are totally serious. I think you would indeed "short" a lawsuit attempting to achieve justice for dying patients (if you thought you could make a buck); you must be one smug piece of work. Well, no doubt to your dismay, it isn't over...it was always a longshot, but Kerry attempted to do something, and continues the effort.
CareToLive Files Appeal...
>>...and I wouldn't count on an appeal,...<<
http://caretolive.com/CTLAPPEALNoticepdf.pdf
Well, looks like you need to work on your counting big guy; this aint over till the fat-cats have been made to sing.
Are punitive damages available in such cases...for willful infringement? Has the company revealed what exact monetary damages it is seeking? Or the formula it is using to arrive at its claim?
IV login problems...
Yeah, they are having technical problems...site is all screwed up.
Thx for all inputs re. GTOP...
Best to all...
Walldiver//others..anyone following GTOP??
"MYVAX" in P-3 for NHL..short interest has been recently stable at approx. 22%; inst. ownership at roughly 34%. Unlike DNDN, GTOP has approx. 33% insider ownership...with no recent sales on the spike.
Our old friend Ashcoff from Brean Murray today had a bit to say re. GTOP's likely chances of success...sounds familiar.
GTOP recently spiked to near $5.00; today it bounced off support at roughly $3.35 on roughly 1.5 X recent volume (3 X avg. volume).
GTOP Genitope: Brean Murray believes Phase 3 MyVax trial will fail (3.56 )
Brean Murray notes GTOP is expected to report Phase 3 results from its MyVax trial in late Dec, and they strongly believe that the trial will fail and drive the co to a near-cash valuation; firm's year-end cash per share estimate is $0.75. They believe that if the Phase 3 MyVax trial fails at the end of the year, GTOP will have a very difficult time justifying optimism for the rest of its clinical and preclinical pipeline for additional fundraising. Firm believes its antibody panels are only commercially viable if MyVax receives approval. The greatest value firm sees in GTOP is the value of its net loss carry-forwards. Firm strongly recommends selling into such strength if it returns.
TIA...
Anyone Following BIOM??...SUPG also received upgrade with $8.00 target.
EDMONTON, Sept. 5 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq: BIOM - News; TSX: BRA - News) today announced the presentation of three-year survival results from a randomized Phase II trial of the Stimuvax® MUC-1 vaccine in non-small cell lung cancer (NSCLC). The results suggest that Stimuvax combined with best supportive care (BSC) may provide survival benefits to patients with unresectable stage IIIB NSCLC who had either responded or had stable disease after initial radio-chemotherapy, compared with patients receiving BSC alone. Dr. Charles Butts, from the Department of Medical Oncology, Cross Cancer Institute, Edmonton, Alberta and lead investigator of the Phase II study presented the data yesterday (Abstract # B1-01) at the International Association for the Study of Lung Cancer (IASLC) Congress in Seoul, South Korea.
ADVERTISEMENT
The updated survival results show that approximately twice as many patients were still alive at three years in the Stimuvax arm compared with BSC alone (49% (n=17) vs. 27% (n=8)), representing a 45% reduction in mortality. As previously reported, patients with stage IIIB locoregional disease who received Stimuvax in this trial also experienced a 17.3 month difference in median survival compared with patients receiving BSC alone (30.6 months vs. 13.3 months, respectively). Patients receiving Stimuvax in this trial also reported mild to moderate side effects limited to flu-like symptoms, gastro-intestinal disturbances and mild injection site reactions.
"The updated survival data are encouraging and support the need for further investigation via the ongoing Phase III trial of Stimuvax as a maintenance therapy for patients with advanced lung cancer," commented Dr. Butts.
Based on the Phase II results, Stimuvax has entered its Phase III development and the START (Stimulating Targeted Antigenic Responses to NSCLC) trial is currently open for enrollment. The START trial is being conducted by Merck KGaA of Darmstadt, Germany, which has licensed worldwide development and commercialization rights to Stimuvax from Biomira. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.
"Patients with unresectable stage III non-small cell lung cancer have significant unmet medical need, and the START study is the first Phase III program to evaluate a therapeutic cancer vaccine in this population," said Dr. Robert L. Kirkman, MD, President and Chief Executive Officer of Biomira. "If these survival results are statistically confirmed in the Phase III trial, Stimuvax has the potential to become an important tool in the treatment of lung cancer."
According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in both men and women worldwide, with approximately 80% of cases classified as NSCLC. Current survival rates for NSCLC are low, with only 16% of patients alive five years post-diagnosis. Unfortunately for most patients, current treatments provide limited success. Stimuvax is an innovative cancer vaccine designed to stimulate the body's immune system to identify and destroy cancer cells expressing MUC1, a protein antigen that is widely expressed on common cancers including lung, breast and colorectal.
About the Phase II Trial
171 patients with ECOG 0-2 stage IIIB/IV NSCLC with stable or responding disease after any first-line chemotherapy with or without radiotherapy were randomized to receive Stimuvax plus BSC or BSC alone. Patients were stratified by stage of disease (IIIB LR or stage IIIB with malignant pleural effusion, and stage IV). Patients in the Stimuvax arm received a single intravenous dose of cyclophosphamide 300mg/m2 followed by 8 weekly subcutaneous immunizations with Stimuvax (1,000(micro)g). While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIB locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group - an improvement of 17.3 months. In the Phase IIb study, side effects were primarily limited to flu-like symptoms, GI disturbances and injection site reactions.
About START - Phase III Trial
START is a multi-center, randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study is expected involve more than 1,300 patients in approximately 30 countries. For more information on the START study, or to find a participating center and eligibility criteria, go to www.nsclcstudy.com. The study is also listed on www.clinicaltrials.gov.
About Stimuvax
Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.
Links to 8/13 MarketWatch, Forbes, and Motley articles...
http://www.marketwatch.com/news/story/force-protection-attractive-buyout-target/story.aspx?guid=%7BE...
http://www.forbes.com/2007/08/13/force-protection-closer-markets-equity-cx_er_ra_0813markets37.html?...
http://www.fool.com/investing/high-growth/2007/08/13/force-protection-victorious-impervious.aspx
My understanding is Vidaza is a precursor of Dacogen...so eventual efficacy should be similar. MOGN reported a 30% increase in Dacogen sales, though there may be short term hit to sales due to the recent Vidaza results.
SUPG seems a screaming buy here, and a prime take out target for MOGN. I began buying back in at the close today, though I really hope this absurd drop continues for a bit longer.
To walldiver and all who rarely frequent the I-Village board anymore.
AMMASS is collecting contributions (see I-Village post # 114679)to place the letter (see I-Village post # 112835) by "barrybonding" to FDA Commissioner A. von Eschenbach in the Washington Post.
All input and contributions would be appreciated. With sufficient public awareness and subsequent pressure, we may be able to force a reconsideration by the FDA.
**IMPORTANT**WALL or others..WE Need an AIPC patient who doesn't qualify for the ongoing Provenge trial.
The Abigail Alliance is searching for at least one AIPC patient whose symptoms preclude him from being acceptable for the current P-3 trial. Someone who is willing to be part of a FOX morning show..on T.V. in New York. Need someone quickly..(in days) for a segment this week.
Someone who, due to the recent FDA decision now has no possibility of access to Provenge.
This is no joke.
cdpayne3@hotmail.com
All job openings removed from DNDN site...
Interesting, Briefing .com is also having "technical" difficulties....been logged off 3 times this morning. Then you add the Blackberry snafu and you begin to wonder.
Looks like I-Village board is down again for the 2nd time this morning.
Excellent point regarding biostat guy's refusal to quantify the liklihood of a false positive.
I was equally dismayed and simply confounded when I heard his response. He basically left any of the less statistically proficient panel member (most of them) completely in the dark. From his response one could have derived that there was no better than a coins flip chance of the efficacy data being reliable.
That answer was devestating, and seemingly intentional. What was just as damning was DNDN not quickly disputing that answer. He could have easily indicated that maybe it wasn't cut and dry....but then gone on to explained that a reasonable guesstimate would have been the "1 chance in 40" estimate (or whatever) and how it was derived.
As you said....I think he knew what the likely chance was, as it had been alluded to in the briefing docks. I have to conclude thus, that it was intentional.
I hope von E. and others in FDA have placed a big question mark by this guy's name in regards to being trustworthy and competent.
BTW I am surprised that a bigger deal hasn't been made of this. I would have thought Ocyan would have been all over that item....has anyone even heard from Ocyan since the panel?
12 participants from 9901 still alive at 4.5 years??
This is truly amazing. Where did you get this information?
OT...Virtually Untreatable TB...OT
>>>Anyone up on which companies are in the forefront on TB drug research? Any TB vaccine research being done??<<<
'Virtually untreatable' TB found
About 1.7 million people die from TB globally each year
A "virtually untreatable" form of TB has emerged, according to the World Health Organization (WHO).
Extreme drug resistant TB (XDR TB) has been seen worldwide, including in the US, Eastern Europe and Africa, although Western Europe has had no cases.
Dr Paul Nunn, from the WHO, said a failure to correctly implement treatment strategies was to blame.
TB experts have convened in Johannesburg, South Africa, to discuss how to address the problem.
TB presently causes about 1.7 million deaths a year worldwide, but researchers are worried about the emergence of strains that are resistant to drugs.
This is very worrying, especially when mixed with HIV
Dr Paul Nunn, WHO
Drug resistance is caused by poor TB control, through taking the wrong types of drugs for the incorrect duration.
Multi-drug resistant TB (MDR TB), which describes strains of TB that are resistant to at least two of the main first-line TB drugs, is already a growing concern.
Globally, the WHO estimates there are about 425,000 cases of MDR TB a year, mostly occurring in the former Soviet Union, China and India.
Treatment requires the use of second-line drugs, which are more toxic, take longer to work and costly.
But now, according to researchers, an even more deadly form of the bacteria has emerged.
High prevalence
XDR TB is defined as strains that are not only resistant to the front-line drugs, but also three or more of the six classes of second-line drugs.
This, according to Dr Paul Nunn, coordinator of the WHO team at the Stop TB department, makes it virtually untreatable.
A recent survey of 18,000 TB samples by the US-based Centers for Disease Control and the WHO between November 2004 and November 2005 found 20% of them were multi-drug resistant and a further 2% were extreme drug resistant.
Further detailed analysis of several countries found the prevalence was even higher.
In the US, 4% of all MDR TB cases met the criteria for XDR TB; in South Korea, the figure was 15%.
In Latvia, and according to Dr Nunn other areas of the Baltics and the former Soviet Union, 19% of all multi-drug resistant cases were extreme drug resistant too.
Dr Nunn said XDR TB was present across several strains, but added it was not yet clear how transmissible it was or whether it was limited to isolated pockets.
HIV peril
But he warned HIV positive people were at particular risk.
He highlighted a study recently presented at the International Meeting for Aids, held in Toronto.
XDR TB is very serious - we are potentially getting close to a bacteria that we have no tools, no weapons against
Paul Sommerfeld, Stop TB
In Kwazulu-Natal, in South Africa, 53 patients were found with XDR TB. Of these, 52 died within 25 days, and 44 of the 53 had been tested for HIV and were all found to be HIV positive.
He said XDR TB could have a bigger impact on developing nations, including Africa, because of the prevalence of HIV.
Dr Dunn said: "This is very worrying, especially when mixed with HIV.
"We need to make sure we do the basics properly, in other words, ensuring, and where necessary, supervising that the patient takes ever pill for the course of the treatment.
"If you do that, then the rate of development of resistance drops dramatically, even in the context of HIV."
He added that it was key that new drugs were developed in future. He said work was underway looking at new drugs, including research into TB vaccines.
The meeting in South Africa will discuss the recent findings and how to curb the growing problem.
Paul Sommerfeld of TB Alert, said: "XDR TB is very serious - we are potentially getting close to a bacteria that we have no tools, no weapons against.
"What this means for the people in southern Africa, who are now becoming susceptible to this where it is appearing, is a likely death sentence.
"For the world as a whole it is potentially extremely worrying that this kind of resistance is appearing. This is something that I am sure the WHO will be taking very seriously."
OT...GNTA
Wow, somebody didn't like something.
OT...Irwin...A little more first hand info.
http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=51832
Unbelievable indeed!!!
My first impression was the ray was probably buried under sand and Steve may not even have been aware its prescence. What an incredible tragedy and loss. Ironically, he had been filming a segment having to do with nature's most deadly creatures but weather had forced a couple of days delay, so he had actually gone down to just get some general film for another project oriented towards children. If it had missed the heart, though excruciating, I think he could have survived.
He was a bright light in a world of turmoil; he amazed and made us laugh, he will be missed. I think though, this is how he would have liked to go, quickly.
i760...
>>I also wonder if some news about the data in CMC section leaked out and was the cause of the trading action...<<
Who can say for sure, the volume was good but not unheard of.
Another likely explanation is of course simple options expiration manipulation.
The 'strike pegger' feature on the optionstoolbox.com site...indicated a close of $4.71 as the price where the options writers incur the minimum liability for satisfying their obligations to the put/call buyers....assuming the writers are mostly the 'big boys' and thus have the power to influence the sh/pr to their favor. Haven't worked with it long enough to validate a percentage for accuracy...but interestingly we did top out at $4.71. Hopefully we can hold, but I won't be surprised to see us back under assault come the new week.
Cheers...
No problem walldiver...
I never suspected you had anything to do with it. It must be as you and Dew have conjectured...simply a weird glitch of some sort. I didn't even know we had a "jail"...am relieved to know I am not a criminal though.
Best wishes and keep up the great work you do here.
P.S. - Did you notice that ENCY rec'd the formal decision letter from the European Commission re. Thelin 100 mg. tabs?
Do you follow ENCY??
Lumpy...
The previous message was actually my second attempt to reply to you...I composed a slightly "better" post first thing this morning and attempted to send it, only to receive a message that I had been placed "in jail" and could no longer post until I made amends for some infraction (unspecified)...I assumed that my "simply too simple" remark was my violation.
But now it appears it may have been some type of mistake, as I am able to post now...??
Lumpy...
If you say you are long, I will accept that at face value. No hard feelings I hope from the previous posting. And please don't get me wrong...I don't criticize anyone for being critical of mngt....I was vigorously assailed (much more than what you endured from me) on the YMB as being a short....all for the infraction of being critical of DNDN management..(well, very critical..but civil), my 'problem' was simply that I couldn't understand how one would honestly doubt that manipulation of DNDN sh/pr has taken place, or how, in view of the published statistics re. Provenge efficasy, one could feel the constant short assault is somehow deserved. However upon further reflection of your posts, I see that your meaning may have been misunderstood by me, though I don't agree that both sides present compelling arguments. I find the arguments against Provenge receiving outright approval to be a bit shallow. Survival is the Gold standard after all. When one considers the superior efficacy/toxicity profile of Provenge vs. Taxotere...it seems Provenge rates as about as close to a slam-dunk as you will find in bio-tech.
Best wishes and success to you mate...amd again my apologies to you for implying you were anything but genuine in your posting.
>>Why would you deny even the possibility of BP manipulation<<
I haven't denied BP manipulation, I am uncertain who specifically is behind the manipulation I perceive...surely a couple of big paharmaceuticals view Provenge as a threat. Did you mean this message for Dew? My arguement acknowledged blatant manipulation, and the market is indeed a dirty business, but I disagree that failure to secure FDA approval first time out is a "real possibility" (more a remote possibility)...I view first time approval as highly probable, but of course not a certainty. A future discussion re. what really constitutes "manipulation" might prove highly interesting.
Good Night and Good Luck to all....Dew included.
That is a rediculous statement Dew...one I would have thought beneath you. I do indeed believe "that"....and am sufficiently successful as a trader. For what it is worth, I have actually made money by trading DNDN. I roughly doubled my core position under $4.00 recently, and sold it at a decent profit when we couldn't maintain our last jaunt above $5.00...and am now in the process of rebuilding it.
You are far too intelligent to resort to such foolish retorts....but if it make you feel good to "feel sorry" for me, so be it.
Baloney...the valuation is so low for the simple reason that it is in the "best" financial interest of a few very well monied entities to keep it that way - through blatant manipulation, intentional mis-representation and mis-interpretaion of the true achievements and potential of Provenge.