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"I shoot low 40's when I go often. Right now I would be happy to shoot 50."
Are you talking about minature golf? I'm happy when I shoot in the 80's.
Looks like GTCB is having a nice breakout.
Press Release Source: Dendreon Corporation
Dendreon Announces Results of D9905 Phase 2 Study of Provenge in Patients with Early Stage Prostate Cancer
Tuesday May 24, 9:00 am ET
Data Presented at the American Urological Association Annual Meeting in San Antonio
SAN ANTONIO, May 24 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced results of an open-label Phase 2 study of Provenge® (APC8015) as a mono-therapy in men with rising PSA post definitive local therapy (androgen-dependent prostate cancer). Provenge is the Company's investigational immunotherapy for the treatment of prostate cancer. The study, referred to as D9905, suggests that Provenge as a single agent may lead to improved PSA doubling time (PSADT) in patients with early stage prostate cancer. PSADT is the time it takes for the prostate-specific antigen (PSA) value to double. This is used to help predict the possibility of metastasis and time to death in early stage prostate cancer. The data were presented at the American Urological Association annual meeting here today.
"We are very encouraged by the findings of this study investigating the use of Provenge as a mono-therapy in men with earlier stage prostate cancer," said Robert M. Hershberg, M.D., Ph.D., Dendreon's chief medical officer. "We believe Provenge may have the potential to alter the course of treatment in early stage prostate cancer and may offer a compelling alternative to either watchful waiting or the use of androgen ablation therapy in this early stage of disease recurrence. We look forward to completing enrollment of our ongoing large Phase 3 study P-11 very soon, which is examining Provenge in patients with androgen-dependent prostate cancer."
Study Details and Results
During the meeting, researchers presented data from a poster entitled, "Immunotherapy (APC8015) for Androgen Dependent, Biochemically-Relapsed Prostate Cancer (D9905)." The data from Study D9905 demonstrated that 71% (12 of 17) of evaluable patients had a prolongation in their PSADT post-treatment with Provenge. After treatment with Provenge, patients had a 52% increase in PSADT (5.2 months to 7.9 months). In addition, in five patients, the post- treatment PSADT was greater than 12 months, with one of these patients showing a 20-fold increase in post-treatment PSADT compared with pre-treatment PSADT (66.6 months vs. 3.5 months). As in previous studies, Provenge also was shown to be generally well tolerated with the most common side effects being fever and chills typically of low grade and short duration.
How does DNA keep doing it? EYET is down huge... $5+ on the news.
Press Release Source: Genentech, Inc.
Preliminary Phase III Data Show Lucentis Maintained or Improved Vision in Nearly 95 Percent of Patients With Wet Age-Related Macular Degeneration
Monday May 23, 4:00 pm ET
SOUTH SAN FRANCISCO, Calif., May 23 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) announced today that a Phase III clinical study of the investigational drug Lucentis(TM) (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD). Approximately 95 percent of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at one year when treated with Lucentis injections compared to approximately 62 percent of those treated in the control arm (p<0.0001). Patients treated with Lucentis for 12 months had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint, while the control group demonstrated a substantial decrease in mean visual acuity from baseline to 12 months. One-year data from the trial will be presented at the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS), July 16 to 20 in Montreal, Canada.
"These Lucentis data exceeded our expectations because they show, for the first time in a Phase III trial, a statistically significant improvement in vision for patients in a disease that has remained chronic and progressive despite current treatment options," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer.
A preliminary analysis of the data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring in the Lucentis arms more frequently than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were rare (<1%) and included uveitis and endophthalmitis. There appeared to be no imbalance in serious non-ocular adverse events.
Lucentis is a humanized antibody fragment developed at Genentech and designed to bind and inhibit Vascular Endothelial Growth Factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels).
"We are excited that our pioneering work at Genentech in the field of angiogenesis has again translated into a potential new treatment option for patients with such a significant unmet medical need," said Barron. "We look forward to sharing these positive Phase III data with the FDA."
About the Study
Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab (formerly, RhuFab) In the treatment of Neovascular AMD (MARINA) is a Phase III study of 716 patients in the United States with minimally classic or occult wet AMD who were randomized 2:1 to receive intravitreal Lucentis injections or a control regimen. The control regimen consisted of a sham injection, meaning the treating physician prepares and anesthetizes the patient's eye but does not perform an injection. Patients treated with Lucentis were further randomized to receive either a 0.3 mg or 0.5 mg dose of Lucentis once a month for two years.
Exclusion criteria included prior subfoveal laser treatment, verteporfin photodynamic therapy (PDT) or experimental treatments for wet AMD. Visual acuity was measured using the Early Treatment of Diabetic Retinopathy (ETDRS) chart, the standard method of quantifying visual acuity.
Ongoing Phase III Studies
Genentech and Novartis Pharma AG are conducting two additional Phase III studies of Lucentis. ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) is a randomized, multi-center, double-masked, active-treatment-controlled Phase III study comparing two different doses of Lucentis to PDT in 423 patients. The trial is ongoing in the United States, Europe and Australia. Results from this study are expected in the fourth quarter of 2005.
A Phase IIIb study of 184 patients, PIER (A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovasularization with or without Classic CNV Secondary to Age-Related Macular Degeneration), is also underway. In this trial, Lucentis is administered once per month for the first three doses followed thereafter by doses once every three months for two years. Results from this study are expected in the first half of 2006.
Books-A-Million (BAMM) because it enhanced its website....
(AP) INTERNET RETAILERS' STOCKS RISE: Shares of companies selling goods over the Internet rose Friday as investors bet that more consumers will do their holiday shopping online, boosting sales. Online music retailer CDNow Inc. rose $9.875 to $26.875. Software merchant Egghead.com Inc. rose $10.187 to $31.625. Internet auctioneer Onsale Inc. rose $37.625 to $97.625. Fellow auctioneer eBay Inc. rose $13.50 to $218. Books-A- Million Inc., a book merchant which introduced an enhanced Web site Wednesday, soared $26 to $38.937. Leading online book merchant Amazon.com Inc. rose $6.312 to $216.625. Egghead.com, which closed all of its bricks-and-mortar retail stores and added ".com" to its name earlier this year, said it plans to introduce a redesigned Web site on Monday that will allow it to offer products beyond software and personal computers. (Bloomberg)
http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yhoo&siteid=yhoo&dist=yhoo&gui...
Able Labs plunges as CEO resigns
By Val Brickates Kennedy, MarketWatch
Last Update: 5:53 PM ET May 19, 2005
BOSTON (MarketWatch) -- Shares of Able Laboratories Inc. plunged Thursday as the generic drugmaker suspended all product shipments and as its chief executive quit.
Able shares were suspended Thursday morning due to the news and immediately plunged after reopening. The stock closed down 75% at $6.26.
Cranbury, N.J.-based Able (ABRX: news, chart, profile) said the product shipments were suspended due to quality-control problems, a move that prompted the immediate resignation of Dhananjay Wadekar as chairman and CEO.
According to Able, Wadekar will continue with the company as a consultant. Robert Mauro, Able's president and chief operating officer, will assume the role of interim CEO, reporting to a special committee of the board of directors.
In a statement, Able said that an ongoing review into its manufacturing procedures had uncovered additional quality-control problems. The problems concerned the company's laboratory testing practices, Able said.
Because it's unable at this time to determine the extent to which production deviated from standard manufacturing practices, the company is suspending all shipment of its products until further notice.
The move comes just a little over a week after the company recalled batches of atenolol, a blood-pressure, drug for lack of potency, according to information on a Food and Drug Administration Web site.
On May 16, Able announced it had promoted Iva Klewick, its director of regulatory affairs, to the newly created position of vice president of compliance, reporting directing Mauro.
Able said that it's been conducting the internal review in the wake of several product recalls. As a result of the new discoveries, the company may also be forced to recall additional products.
Able manufactures generic versions of dozens of brand-name prescription and over-the-counter medications, including Tylenol, Ritalin, Anusol and Vodicin.
The company operates manufacturing facilities in Cranbury and South Plainfield, N.J. Able had been in the process of ramping up its new Cranbury site as its primary manufacturing facility, a move that would have increased manufacturing capacity by up to 400%. The plant was expected to go online during the second quarter, according to Able's Web site.
Able added that is was uncertain what type of regulatory action that the FDA might take against the company.
On April 2004, the agency sent a warning letter to Able, charging it with failure to report adverse reactions to its medications to regulatory authorities.
As a result of suspension, Able said it was withdrawing its previously issued financial forecast.
Dew,
In regards to GTCB, what is your latest probability of EMEA approval? Just trying to determine if I should be buying more at the current levels.
Thanks,
10nis
STEM is moving up on the news...
BREAKING NEWS.......
http://www.newsday.com/news/health/ny-hsstem0520,0,2546583.story?coll=ny-top-headlines
Health/Science
--------------------------------------------------------------------------------
Korean scientists clone stem cells
THE ASSOCIATED PRESS
May 19, 2005, 2:31 PM EDT
WASHINGTON -- South Korean scientists have created the world's first human embryonic stem cells that are customized to injured or sick patients, a major step in the quest to grow patients' own replacement tissue to treat diseases.
These same scientists last year became the first to clone a human embryo, sparking international clamor. But those cloned stem cells -- the building blocks that give rise to every tissue in the body-- were a genetic match to a healthy woman, not a sick person. And it wasn't easy: It took 242 donated human eggs to grow just one batch.
Now the Seoul scientists have cloned patient-specific stem cells, important if doctors are to develop cell-based therapies that won't be rejected by the body's immune system. The technique worked with males and females, as young as 2 and as old as 56 -- all suffering either spinal cord injuries, diabetes or a genetic immune disease, the researchers report in Friday's edition of the journal Science.
And the Korean lab found faster and safer ways to cull stem cells, using far fewer donated eggs -- about 20 per try. They also eliminated use of mouse "feeder cells" that have been used to nourish most human stem-cell lines, thus easing concerns about contamination.
Any therapy is still years away from being tested in people.
"Therapeutic cloning has tremendous, tremendous healing potential, but we have to open so many doors before human trials," lead researcher Hwang Woo-suk of Seoul National University said in a telephone interview. "Our work reveals the possibility that this technology could be applied in the patient himself in the future."
Stem-cell specialists called the research remarkable.
"This is a very important advance," said Dr. Janet Rowley of the University of Chicago, a genetics specialist who helped co-author recent ethics guidelines on stem-cell research from the Institute of Medicine. "It's surprising to me the amount of progress they've made in basically a year's time."
"This paper will be of major impact," said stem-cell researcher Dr. Rudolph Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Mass. "The argument that it will not work in humans will not be tenable after this."
The work marks "a gigantic advance" for another reason, said neuroscientist Fred Gage of the Salk Institute for Biological Studies in San Diego. By cloning stem cells from sick patients, scientists can watch, in a test tube, the very earliest origins of diseases like Alzheimer's, insight that could point to other ways to prevent and treat illness, explained Gage, who plans to do some of that work.
The Korean research "will be a tremendous boon to the investigation of the nature and biology of human disease," he said.
It's also sure to revive international controversy over whether to ban all forms of human cloning, as the Bush administration wants -- or to allow cloning for medical research, so-called therapeutic cloning that South Korea has committed by law to pursue.
Culling stem cells destroys the days-old embryo harboring them, regardless of whether that embryo was cloned or left over in a fertility clinic. Because opponents argue that is the same as destroying life, President Bush has banned federally funded research on all but a handful of old embryonic stem-cell lines -- and the South Korean work spotlights the frustration many U.S. scientists felt at being left behind.
"It's just going to highlight the tragedy of our current situation in America where there are technologies that are promising that are not being pursued by talented American scientists because of ideologic constraints," Rowley said.
The Seoul researchers collected eggs donated by 18 unpaid volunteers and removed the gene-containing nucleus from them. They inserted into those eggs DNA from skin cells of 11 people who had spinal cord injuries, Type 1 diabetes or a congenital immune disease.
Chemicals jump-started cellular division, and 31 blastocysts -- early-stage embryos -- successfully grew. From those, the scientists were able to harvest 11 colonies, or "lines," of stem cells, each one a genetic match to the patient who had donated a skin snippet.
The scientists were careful to explain to the research participants that getting medicine made from their stem cells is a long shot. They don't yet know how to control which types of tissues -- brain cells, bones, muscles, etc. -- the stem cells form, something the Korean lab is studying next.
"I didn't think they would be at this stage for decades, let alone within a year," said Dr. Gerald Schatten of the University of Pittsburgh, who acted as an adviser to the Korean lab in analyzing its data for U.S. publication. "All of us in the biomedical communities owe our colleagues in Korea a tremendous debt of gratitude."
The work raises ethical concerns, cautioned Stanford University bioethicists David Magnus and Mildred Cho. Scientists must ensure that women understand they get no benefit and can be put at some risk when they agree to donate eggs for medical research -- and that patients who volunteer also understand that it's unlikely they'll benefit from any stem cells they help to clone because so many years of research are yet required, they wrote.
Very impressed by the lack of cellphone, DEW!! I got my first one last June however, only because I was told I wouldn't get promoted without one.
Tax laws bolster Pfizer's coffers
- PHARMACEUTICALS.
COMPANIES INTERNATIONAL
By CHRISTOPHER BOWE and JAMES POLITI
384 words
16 May 2005
Financial Times
USA Ed1
Page 24
English
(c) 2005 The Financial Times Limited. All rights reserved
Pfizer's cash pile is enough to buy nearly all publicly traded US biotechnology companies, according to an analysis by Deutsche Bank.
Recent US tax law changes prompting repatriated foreign profits have bolstered the coffers of the world's largest drugmaker and it plans to repatriate up to Dollars 38.9bn - and at least Dollars 28.3bn in foreign earnings.
If added to Dollars 1.5bn in cash on hand and Dollars 20bn in short-term investments, according to first-quarter regulatory filings, Pfizer could have nearly Dollars 60bn in cash, giving it unparalleled strength in a profitable but fragmented industry.
The Deutsche Bank review calculated that Pfizer's cash position was equivalent to the market capitalisations for the 179 listed US biotech groups outside the top 20, which includes giants such as Amgen. The combined market capitalisation of the 179 biotech companies was Dollars 45.3bn. The top 10 had a combined market capitalisation of Dollars 226.9bn, and the next 10 totalled Dollars 17.3bn.
Although most of Pfizer's rivals have solid balance sheets, few, if any, have such cash power. Pfizer has Dollars 52bn in annual sales.
However, the money underscores the struggle in the industry to find new drugs. Pharmaceuticals companies must trawl for drugs - or companies with pipelines - worthy of development. It can cost up to Dollars 800m to bring a drug to market.
Wall Street is concerned about slowing growth due to patent expiries and uncertain productivity in their research laboratories and new drug pipelines.
Last year's tax changes and a new jobs law mean other major US pharmaceutical companies need to decide what to do with cash stockpiles. Bristol-Myers Squibb is repatriating Dollars 9bn, Eli Lilly's total is Dollars 8bn, Schering-Plough's Dollars 9.4bn, while Merck is considering whether to bring back Dollars 15bn, and Wyeth Dollars 2.7bn, according to filings.
Pfizer could afford to buy the second tier of top US biotech groups. "The planned use of proceeds includes domestic expenditures relating to advertising and marketing activities, research and development activities, capital assets and other asset acquisitions, and non-executive compensation in accordance with the act," it said in a recent filing.
GTCB was reiterated today by Rodman & Renshaw with a MARKET OUTPERFORM rating (per Dow Jones). That could explain some of today's spike.
I'm definitely the farthest thing from an expert, however, assuming DN-101 and GTIX have to conduct two to three year long Phase III studies, they are a good distance behind DNDN. Right?
http://biz.yahoo.com/bw/050513/135150.html?.v=1
Press Release Source: ADVENTRX Pharmaceuticals, Inc.
ADVENTRX Reports Positive Preliminary Phase II Trial Results with CoFactor in Metastatic Colorectal Cancer
Friday May 13, 1:05 pm ET
Data Show Increased Response Rate and No Grade 3/4 Gastrointestinal or Hematological Toxicity
SAN DIEGO--(BUSINESS WIRE)--May 13, 2005--ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX - News) today announced a 63% overall clinical benefit and a 38% objective response rate in measurable patients treated with CoFactor(TM) and 5-fluorouracil (5-FU) as a first-line treatment of metastatic colorectal cancer in its Phase II trial. Furthermore, patients enrolled in this trial have exhibited no grade 3 or 4 gastrointestinal or hematological toxicities as determined in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events grading system. Patients continue to be followed for time-to-tumor progression and overall survival. Of the 50 patients enrolled in the trial, 48 are available for tumor response assessment and 44 have been evaluated for tumor response as of May 13. ADVENTRX currently plans to announce response data on all patients in June at the World Congress on Gastrointestinal Cancer in Barcelona, Spain, and final results, including time-to-tumor progression and early survival, from this trial in the fourth quarter of this year.
"To date our Phase II trial with CoFactor and 5-FU has demonstrated objective response rates of 38%. This is more than double the rate of 11-17% historically observed in clinical trials treating metastatic colorectal cancer patients with leucovorin and 5-FU, but with none of the typical grade 3 or 4 toxicities," said Evan M. Levine, president and CEO for ADVENTRX. "These results suggest that CoFactor increases the potency of 5-FU, while lowering toxicity compared with 5-FU/leucovorin treatment regimens. Based in part on these and earlier positive Phase II CoFactor data, we have received clearance under a Special Protocol Assessment (SPA) from the US Food and Drug Administration to begin a Phase III pivotal trial and clearance in the United Kingdom to begin an international Phase IIb trial using CoFactor and 5-FU as a first-line combination therapy in metastatic colorectal cancer. We plan to initiate both of these trials this year."
The Phase II clinical trial is an open label, single arm Simon 2 stage study design to assess the safety and efficacy of CoFactor plus 5-FU as a first-line treatment of metastatic colorectal cancer. CoFactor is ADVENTRX's biomodulator designed to enhance the effects of the widely used cancer drug 5-FU.
Available objective response data from the Phase II trial showed 38%, or 18 patients, responded to treatment with CoFactor and 5-FU, surpassing the trial's response rate objective of 25%. To date, 12 patients have exhibited stable disease and 14 have progressive disease. World Health Organization criteria were used to define response as follows: complete response is a complete disappearance of the tumor; partial response is at least a 50% reduction in total tumor size; stable disease is less than a 50% reduction in total tumor size; and progressive disease is at least a 25% increase in tumor size at the end of the treatment cycle, as measured by CT or MRI scans. Objective response is defined as all patients having complete or partial responses, whose tumor measurements are confirmed by MRI or CT scan by repeat assessment performed no less than four weeks after the criteria for response is first met. The primary endpoint for the study, objective response, was evaluated at the completion of two cycles at week 16 with the exception of those patients that progressed as established by radiological assessment at the end of the first cycle (eight weeks). Clinical benefit is defined as tumor response or stable disease following study therapy. Other efficacy endpoints still being evaluated are time-to-tumor progression and overall survival.
Safety data is available for all 50 patients. The clinical trial's treatment regimen of CoFactor plus 5-FU (COFU) was well tolerated, with no grade 3 or 4 gastrointestinal or hematological toxicities reported to date. The most common adverse events (AEs) were diarrhea, nausea and vomiting, none of which were grade 3 or 4. There was one additional adverse event, a single case of grade 3 watery eye.
Selected preliminary results of ADVENTRX's Phase II trial were published in the American Society of Clinical Oncology (ASCO) 2005 Annual Meeting Proceedings (abstract #3692). This abstract is available via ADVENTRX's Web site at www.adventrx.com.
ADVENTRX recently received clearance in the US under an SPA to begin a Phase III pivotal study of CoFactor in metastatic colorectal cancer. The Company also received clearance in the United Kingdom to begin an international Phase IIb trial with CoFactor and 5-FU in metastatic colorectal cancer. The Company plans to file in the first half of this year for clearance to initiate an EU-based Phase III CoFactor study in pancreatic cancer.
About the Phase II COFU trial
Patients enrolled in this trial are age 18 and older with ECOG 0-2 and measurable metastatic colorectal cancer, with or without adjuvant 5-FU/leucovorin, irinotecan or oxaliplatin, but no prior chemotherapy for metastatic disease. Patients may receive more than two cycles each consisting of CoFactor 60 mg/m2 and 5-FU 450 mg/m2 (weekly IV bolus) for six consecutive weeks, followed by a 14-day rest period, which is defined as a cycle. Pre-established response criteria are greater than four responders of 23 patients for stage one, and greater than 12 responders of 48 patients for the full trial. The median age of patients was 65.5 (range 42-86), and mean number of doses was 10.2 (range 1-24). The clinical response is evaluated at the completion of two consecutive cycles. The trial is being conducted in the US and Europe under a US investigational new drug application (IND).
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug developed to enhance the activity of the widely used cancer chemotherapeutic 5-FU. Data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumors, including colorectal, pancreatic and breast. In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU, FdUMP, to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. This improves 5-FU performance and lowers toxicity. ADVENTRX is the exclusive licensee of this compound. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability or resistance. More information can be found on the Company's Web site at www.adventrx.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's last annual report on Form 10-KSB, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
--------------------------------------------------------------------------------
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn, 858-552-0866
or
Investor Contact:
Lippert Heilshorn & Associates
Jody Cain (jcain@lhai.com)
Brandi Floberg (bfloberg@lhai.com)
310-691-7100
or
Media Contact:
Lippert/Heilshorn & Associates
Mark Stuart (mstuart@lhai.com)
310-691-7116
For those OXGN lovers...
http://biz.yahoo.com/bw/050513/135449.html?.v=1
Press Release Source: OXiGENE Inc.
OXiGENE Announces Presentation at ASCO of Positive Tumor Response Data in Phase Ib Trial of CA4P With Chemotherapy
Friday May 13, 1:15 pm ET
WALTHAM, Mass.--(BUSINESS WIRE)--May 13, 2005--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN)
Clinical Investigator Reports that CA4P in Combination
with Carboplatin and/or Paclitaxel Indicates
Anti-tumor Activity and No Unexpected Toxicity
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) today announced that Combretastatin A4 Prodrug (CA4P), the Company's lead vascular targeting agent (VTA), indicated both "anti-tumor activity" and "no unexpected toxicity" thus far in the Phase Ib portion of a planned Phase Ib/II combination trial of the compound in patients with advanced cancer. These preliminary findings are described in an abstract entitled "A Phase Ib trial of combretastatin A-4 phosphate (CA4P) in combination with carboplatin or paclitaxel chemotherapy in patients with advanced cancer" published for attendees of the 2005 American Society of Clinical Oncology Annual Meeting taking place May 13th-17th in Orlando, Florida.
The abstract details the results of the first 21 patients entered into the Phase Ib study who received CA4P with either carboplatin or paclitaxel in advanced cancer and advanced ovarian cancer. The abstract reports that there has been "no cardiotoxicity and minimal myelosuppression. Tumor response as defined according to RECIST or CA125 has been seen in 6 out of 9 evaluable patients with ovarian cancer and one patient with rapidly progressing renal papillary cancer stabilized for 4 months." In summary the authors state, "The combination of CA4P, with either carboplatin or paclitaxel, is well tolerated and the anti-tumor activity seen requires further studies."
In addition to the data described in the abstract, the lead investigator of the trial, Gordon Rustin, M.D., Director of Medical Oncology at Mount Vernon Cancer Centre in the United Kingdom, today noted that, "Additional patients have now been recruited which will complete both the CA4P plus paclitaxel and CA4P plus carboplatin dose escalation groups. These groups involve treatment with a dose of 54mg/m(2) of CA4P and either 175mg/m(2) of paclitaxel or AUC 5 of carboplatin. No unexpected toxicities above those typically anticipated from carboplatin or paclitaxel alone have been observed. In addition to the aforementioned responses seen in the ovarian patients, including those previously resistant to carboplatin, we also have recorded another ovarian patient response resulting in a total response rate of 58% or (7 out of 12 ovarian patients). We have also now observed a partial response as measured by RECIST in a patient with relapsed small cell lung cancer." Professor Rustin added, "We anticipate completing this trial and moving forward with the triple combination into a multi-center Phase II trial with carboplatin resistant ovarian patients later this year."
"These results with CA4P are very positive in that the investigators have dose escalated to routinely used levels of both carboplatin and paclitaxel with no increase in toxicity over that seen with the chemotherapy agents alone," commented Fred Driscoll, OXiGENE's President and Chief Executive Officer. "We are also pleased to see accumulating evidence of anti-tumor activity in the Phase Ib segment of the trial even before we start the final cohorts of patients in Professor Rustin's study who will receive the triple combination of CA4P with both carboplatin and paclitaxel. We are now actively recruiting new centers to become involved in order to accelerate patient recruitment for the Phase II study currently targeted to start in Q4 2005."
The Phase Ib/II trial of CA4P in combination with carboplatin or paclitaxel is being conducted at three centers in the UK and the USA. The Phase Ib portion of the trial is designed to establish the optimal schedule, maximum tolerated dose for the combination of CA4P and carboplatin, and for the combination of CA4P and paclitaxel, and to assess safety and tolerability. In addition, researchers will gather preliminary data to determine the anti-tumor activity and the recommended Phase II dose for the triple combination of CA4P-carboplatin-paclitaxel.
About Combretastatin A4P (CA4P)
CA4P leads a novel class of drug candidates which have been referred to by OXiGENE as vascular targeting agents (VTAs). CA4P attacks the vascular structure of solid tumors and other diseases characterized by the formation of aberrant blood vessels. The compound triggers a change in the shape of the endothelial cells lining these blood vessels, in turn blocking the flow of blood to a tumor and depriving it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels.
CA4P is currently being studied in seven clinical trials in oncology, including anaplastic thyroid, lung, head and neck, prostate, colorectal, ovarian, cervical cancers and other image able tumor types. These clinical trials involve the use of CA4P in both single-agent and combination therapies. It is also currently being studied in a Phase I/II trial in wet age-related macular degeneration and a Phase II trial in myopic macular degeneration.
About OXiGENE, Inc.
OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients.
Safe Harbor Statement
Certain statements in this news release concerning clinical trials being conducted on OXiGENE's lead VTA, CA4P, are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the timing and results of clinical development of CA4P; and the availability of resources to execute on critical corporate objectives over the next two years. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
--------------------------------------------------------------------------------
Contact:
OXiGENE Inc.
James Murphy, 781-547-5900
jmurphy@oxigene.com
or
MacDougall BioCommunications
Chris Erdman, 508-647-0209
chris@macbiocom.com
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Source: OXiGENE Inc.
http://biz.yahoo.com/prnews/050513/sff030.html?.v=9
Press Release Source: Telik, Inc.
Telik Reports Positive Interim Results of TELCYTA in Combination With Carboplatin and Paclitaxel in First-Line Non-Small Cell Lung Cancer
Friday May 13, 1:00 pm ET
PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive interim data from a multicenter Phase 1-2a clinical study evaluating TELCYTA(TM) (TLK286) in combination with carboplatin and paclitaxel in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the annual meeting of the American Society of Clinical Oncology. In the trial, a 62% objective response rate (by RECIST), including one complete response and seven partial responses and a disease stabilization rate of 92% were observed in the evaluable patients at the time of the interim analysis.
At the time of analysis, all 13 patients in the Phase 1 stage of the trial were evaluable for safety and efficacy. Four dose levels of TELCYTA were evaluated (400, 500, 750 and 1,000 mg/m2) along with standard doses of carboplatin (AUC 6) and paclitaxel (200 mg/ m2), administered every three weeks.
Responses were accompanied by improvement in clinical symptoms as well as performance status. Objective responses were observed in both squamous cell and adenocarcinoma subtypes, in males and females, and in current, former and never smokers. Overall the TELCYTA combination was generally well tolerated, without unanticipated toxicities. Median survival has not yet been reached
"While it is early, I am very encouraged by the responses seen with the combination of TELCYTA, carboplatin and paclitaxel," said Thomas J. Lynch, M.D., Medical Director, Center for Thoracic Cancers, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School and Principal Investigator of the study. "TELCYTA is a new type of tumor-activated chemotherapeutic that may add activity to the widely used carboplatin/paclitaxel regimen. Non-small cell lung cancer is the leading cause of cancer death in America, and it is essential that we confirm these exciting preliminary data."
About TELCYTA
TELCYTA is a novel, small molecule tumor-activated drug candidate. It is activated by GST P1-1, an enzyme present in cancer cells. Upon activation, an intracellular process known as apoptosis, or programmed cell death, occurs. TELCYTA has been evaluated in multiple Phase 1 and 2 clinical trials as a single agent and in combination regimens in advanced ovarian, non-small cell lung, breast and colorectal cancer.
Three Phase 3 registration trials of TELCYTA are underway: ASSIST-1, a single agent trial in platinum refractory or resistant ovarian cancer; ASSIST- 2, a single agent trial in platinum resistant non-small cell lung cancer; and ASSIST-3, a trial to evaluate TELCYTA in combination with carboplatin in second line platinum refractory or resistant ovarian cancer. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP. For additional information on the ASSIST trials in ovarian cancer, visit www.ASSIST-ovarian.com; additional information on the ASSIST trial in non-small cell lung cancer may be found at www.ASSIST-2trial.com
Conference Call and Webcast
Telik will host a conference call today at 4:30 p.m. Eastern time (1:30 pm. Pacific time). The conference call will be accessible via Telik's website at www.telik.com or by telephone at 877-209-0397 or 612-332-1025. An archive of the conference call will be available on the Telik website or by telephone at 800-475-6701 or 320-365-3844, access code 780992, from approximately 8:00 p.m. Eastern time on May 13 through May 20, 2005.
About Telik
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working to discover, develop and commercialize small molecule drugs to treat serious diseases. The company's most advanced drug development candidate is TELCYTA (TLK286), a tumor-activated small molecule product candidate that is in Phase 3 registration trials in advanced ovarian and non-small cell lung cancer. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including any statements regarding the potential for TELCYTA (TLK286) to treat one or more types of cancer. There are a number of important factors that could cause Telik's results to differ adversely and materially from those indicated by these forward-looking statements, including, among others, the following: none of Telik's product candidates, including TELCYTA, has been determined to be safe or effective in humans or received regulatory approval for marketing; it may take Telik several years to complete clinical trials of its product candidates, including TELCYTA, prior to seeking regulatory approval for any indication; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of clinical trials do not necessarily predict final results; if Telik's competitors develop and market products that are more effective than Telik's product candidates, or obtain regulatory approval before Telik does, Telik's commercial opportunity will be reduced or eliminated; if Telik does not obtain regulatory approval to market its products in the United States and foreign countries, it will not be permitted to commercialize its product candidates; if Telik is unable to contract with third parties to manufacture its product candidates in sufficient quantities and at an acceptable cost, clinical development of product candidates could be delayed; and if Telik is unable to raise adequate funds in the future, it will not be able to continue to fund its operations and clinical trials to develop its product candidates. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its quarterly report on Form 10-Q for the quarter ended March 31, 2005. TELIK, TRAP, TELCYTA and TELINTRA are trademarks of Telik, Inc. All other brand names or trademarks appearing in this press release are the property of their respective owners. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
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Source: Telik, Inc.
Has anyone looked into WEDX (Westaim - a Canadian company with $103 million, no debt, and currently has a market cap of $227 million)? It seems like an interesting company with two very different subsidiaries under its umbrella (Nucryst - which provides anti-microbial wound care products and pharmaceuticals, and iFire - Low cost flat-panel displays/Televisions.)
Just wondering if anyone else has looked into this company at all.
TIA,
10nis
Just a very old article that's worth another laugh. At least this time, Cramer choose to make a fool of himself on television...
http://www.thestreet.com/funds/smarter/891820.html
The Winners of the New World
By James J. Cramer
2/29/00 9:42 AM ET
Editor's Note: James J. Cramer is the keynote speaker at the 6th Annual Internet and Electronic Commerce Conference and Exposition, held today at the Jacob Javits Center in New York City. We're running the full text of that speech here.
You want winners? You want me to put my Cramer Berkowitz hedge fund hat on and just discuss what my fund is buying today to try to make money tomorrow and the next day and the next? You want my top 10 stocks for who is going to make it in the New World? You know what? I am going to give them to you. Right here. Right now.
OK. Here goes. Write them down -- no handouts here!: 724 Solutions (SVNX:Nasdaq - news), Ariba (ARBA:Nasdaq - news), Digital Island (ISLD:Nasdaq - news), Exodus (EXDS:Nasdaq - news), InfoSpace.com (INSP:Nasdaq - news), Inktomi (INKT:Nasdaq - news), Mercury Interactive (MERQ:Nasdaq - news), Sonera (SNRA:Nasdaq - news), VeriSign (VRSN:Nasdaq - news) and Veritas Software (VRTS:Nasdaq - news).
We are buying some of every one of these this morning as I give this speech. We buy them every day, particularly if they are down, which, no surprise given what they do, is very rare. And we will keep doing so until this period is over -- and it is very far from ending. Heck, people are just learning these stories on Wall Street, and the more they come to learn, the more they love and own! Most of these companies don't even have earnings per share, so we won't have to be constrained by that methodology for quarters to come.
There, now that that's done with, can we talk about the methodology that produced those top 10 so that you can understand how, in a universe of a gazillion stocks, we arrived at those, so you too can figure it out? I hope we can because I have another 10 and still another 10 and another. They all do the same thing: They make the Web faster, cheaper, better and easier to access anywhere, anytime. They allow you to get on the Web securely anywhere in the world. They make the Web economy the only economy that matters. That's all they do.
We try to own every one of them. Every single one. And if I had my druthers, I wouldn't own any other stocks in the year 2000. Because these are the only ones worth owning right now in this extremely difficult, extremely narrow stock market. They are the only ones that are going higher consistently in good days and bad. I love every one of them, just as I loathe the rest of the stock universe.
How did this stock market get like this, to where the only people who can make a dime in it are the people who are interested in the most arcane subject, the moving of data from one space to another, via strange new machines and software? How did it get to the point where nothing else matters, most particularly the 90% of the stock market I have studied for the last 20 years? How did all of that knowledge become totally irrelevant and the only stocks that work are the stocks of companies that didn't exist five years ago and came public in the last two or three years?
Let's start with the world in the early 21st century, a world where capital is abundant for a chosen few and nonexistent for just about everybody else. It is a world where the whole of Wall Street and Silicon Valley is at your fingertips if you are creating the infrastructure for the New Economy, and a world where neither Wall Street nor Silicon Valley could give a darn about you if you are using that infrastructure.
Or in other words, we don't care if General Motors (GM:NYSE - news) and Ford (F:NYSE - news) are going with Oracle (ORCL:Nasdaq - news) or with i2 (ITWO:Nasdaq - news) for their new parts procurement process. We don't want to own GM or Ford on any occasion. In fact, we would rather own the loser in that tech bake-off than the winner in nontech, because in this new world, there is so much business to be done for the i2s and the Oracles that the capital will remain plentiful for them, win or lose a particular piece of business.
Just yesterday I found myself wishing I had bought i2 when it lost out to Oracle for the giant business-to-business contract for the Big Three automakers. Others had the same idea because i2, the loser Friday, was up much more Monday than GM and Ford could be this year. i2 can own the world because the company with the access to cheap capital always wins. And the companies with no access have to lose.
Or, closer to home. We in the stock market don't care that The Street.com Inc. (TSCM:Nasdaq - news), a company I helped create, has built a compelling new brand, has more than 100,000 paid subscribers and has $100 million in the bank. We just want to know which companies TheStreet.com employs to publish each day. We want to know who the host is, which publishing tool works best, which wireless strategy TheStreet.com is adopting and how does it automate its email? (By the way, the answers are Exodus, Vignette (VIGN:Nasdaq - news), Motorola (MOT:NYSE - news) and Kana (KANA:Nasdaq - news) -- all at or near their 52-week highs as TheStreet.com languishes at its 52-week low, a triumph of the arms merchants over the combatants if there ever were one.)
How did this bizarro world where nine-tenths of the companies I have followed as a stock picker for the last 20 years are losers and one-tenth are winners? To answer that question, you have to throw out all of the matrices and formulas and texts that existed before the Web. You have to throw them away because they can't make money for you anymore, and that is all that matters. We don't use price-to-earnings multiples anymore at Cramer Berkowitz. If we talk about price-to-book, we have already gone astray. If we use any of what Graham and Dodd teach us, we wouldn't have a dime under management.
So how do we sort through which stocks get bought and which stocks get assigned to the waste bin?
We have a phrase on Wall Street. It's called raising the bar. If you can raise the bar, or brighten the outlook for your company, if you can see your growth accelerating, your stock will go higher and you will be given the currency to expand, acquire and do whatever you want. That's the secret of the quintessential New Economy stock: Cisco (CSCO:Nasdaq - news). This giant networker has the ability to control its own destiny. It can, as my colleague Adam Lashinsky says at TSC, buy any company it wants to. It can pay any price. Because it has a currency that it better than U.S. dollars: It has Cisco stock. It can do that because it raises the bar every quarter!
But what about the Old Economy stocks? Can Merck (MRK:NYSE - news) raise the bar? Can Pfizer (PFE:NYSE - news)? Can U.S. Steel (X:NYSE - news)? Or Phelps Dodge (PD:NYSE - news)? Union Pacific (UNP:NYSE - news)? No, no, no, no, no and no. So what happens to them? Despite the billions in buybacks and the plethora of strong buys that the Street has put out about these companies, their stocks have no traction. They just stumble along, rising and falling haphazardly with every whim and quizzical speech of the Federal Reserve chairman that still controls their destiny. If Greenspan indicates that there is more tightening ahead, these traditional companies, the ones that you measure with traditional matrices, get pole-axed as we worry about where the capital will ultimately come from if credit gets choked off, while the arms merchants in the Web war, with capital to burn, just go higher.
It is no secret that the Dow, made up principally of companies that can't raise the bar, is down 12% while the Nasdaq, which is made up of companies that can raise the bar, is up 12%. And in the self-fulfilling jungle that is Wall Street, only growth can maintain growth!
So how do we find what are the great growth companies, knowing that growth and not cheapness of stock to company is what matters? We have to look for the fastest-growing industries and then select the companies that can make the infrastructure happen the fastest and the cheapest in those industries. The growth must be positively organic, if not viral. There must be heavy technological barriers to entry. And there must be an ability to scale without any thought to human cost. These companies must be able to dominate their businesses or be willing to become part of a larger institution that dominates.
So, whom does that eliminate? First, any company that is a commodity producer simply can't be owned, no matter what. The New Economy makes those be simply a function of low-cost producer with no ability ever to raise price. This, of course, is the crying shame of the way the Fed is trying to break the economy because the only place that could stand for a little inflation is in the deflationary commodity industries. But their inflation revolves around the ability to build inventory to anticipate future price hikes and the Fed is taking short rates to a height that makes it uneconomic to stockpile.
Second, it eliminates any bricks-and-mortar company that doesn't embrace the Net. To not embrace the Net is to give a cost edge to a competitor who does. It does so because the Net removes the middleman that was a product of the regional economy. There is $4 trillion worth of wholesaling that gets instantly eliminated by the Net. Before only the largest orders could be processed by the biggest companies because it was too expensive otherwise. Now all orders can be processed by the biggest companies through the Web. There is no need for the jobber or the wholesaler. Obviously, if you are still using that old distribution network, you can't compete against those who do.
Third, it eliminates any industry that does not have a proprietary brand. This is one of those weird features of the Web that people haven't woken up to yet, but it will seem obvious a few months from now. In the New World's economy, the desire to "name your own price" is too great to squelch. An outfit like priceline (PCLN:Nasdaq - news) will change the very nature of brands in this country. It won't destroy the premium brand, but it will force everyone else out of the market. Why? Because the way priceline works is that we are trying to buy the premium brand for the price of the off-price brand. That means the off-price brands, whether they be Colgate (CL:NYSE - news) or Dial (DL:NYSE - news) or Hunt's or Ralston (RAL:NYSE - news), are simply doomed by the Web. Why would you ever buy the second- or third-best when you can get the best via priceline for the same price as the lower tier? Ahh, that's a real killer. It leaves only the top brands to vie for supermarket space. The others won't be worth carrying. They won't move! Oh yeah, same goes for the airlines and the hotels and just about everybody else.
Fourth, it just destroys retail as we know it. Why? Because the companies that embrace the Web more vigorously will eventually be pitted against other companies that embrace the Web more vigorously, creating a virtual constant price war, the kind of war that Marx, of all, actually predicted would happen to capitalism. It will happen to retail once everyone realizes that Amazon (AMZN:Nasdaq - news) recreated Wal-Mart (WMT:NYSE - news) online because it will forever have access to cheap capital. Why do I say forever? Because at a certain point, it will be done with its buildout and will effectively be able to cherry-pick whomever it wants to destroy while having it be subsidized by other areas. It will be Home Depot (HD:NYSE - news) vs. Wal-Mart vs. Amazon in the end. Nobody else. And that's only if Home Depot figures out it better get on the Web and fast.
Fifth, it wipes out everybody who straddles the Old and New Worlds. Let's take the brokerage industry. If you are trying to preserve a price point, because you need those margins, you can't and you become roadkill. Same with journalism. If you are free online and cost offline, you will eventually not be able to charge offline. Why not? Because the Hewlett-Packards (HWP:NYSE - news) and Intels (INTC:Nasdaq - news) and Ciscos are bent on making the online version far superior to the offline version. And they will do it. They, too, have the access to capital to make it happen.
I can tell you from TheStreet.com that we have substantial cost advantages over our printed cousins. We can come out around the clock. We don't require paper, ink, delivery people or trucks. In that sense, we are much more like television, personal television, which is why we were wrong initially to think we could charge for basic news, and right to think we can charge a huge amount for proprietary analysis that can make you money.
The struggle between the offliners and the onliners in banking will also pan out just like these other industries, with huge wins for those with a fresh online culture and hideous losses for those who don't see it coming or are slow to adjust. If you have to preserve your giant branch network and the costs that come with it while someone else perfects secure wireless Internet transactions, you can forget about it. You can't afford to compete. How can Bank of America (BAC:NYSE - news) compete with Nokia (NOK:NYSE ADR - news) as a way to bank? How can Goldman Sachs (GS:NYSE - news) compete with Yahoo! (YHOO:Nasdaq - news) as a way to invest? Isn't Nokia, with its wireless machine that goes everywhere a better bank than one that needs branches? Isn't Yahoo!, with its access to all of the information and quotes in the financial world a better place to buy stocks than Goldman?
Of course they are.
So, if you can't own the retailers, and you can't own transports, and you can't own banks and brokers and financials and you can't own commodity makers and you can't own the newspapers, and you can't own the machinery stocks, what can you own?
A-ha, that just leaves us with tech. That's why we keep coming back to it. That's why, despite the 80% increase in the Nasdaq last year, we are looking at another record year now. It is by that process of elimination that I have picked my top 10. And my next 10 and my next 10 after. Only those companies are worth owning. The rest?
You can have them.
Thank you.
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James J. Cramer is manager of a hedge fund and co-founder of TheStreet.com. At time of publication, his fund was long 724 Solutions, Ariba, Exodus, Digital Island, InfoSpace, Inktomi, Mercury Interactive, Sonera, VeriSign, Veritas Software, Oracle, TheStreet.com, Vignette, Motorola, Cisco, Intel, Nokia, Goldman Sachs, and Yahoo!, and Cramer was long TheStreet.com. His fund often buys and sells securities that are the subject of his columns, both before and after the columns are published, and the positions that his fund takes may change at any time. Under no circumstances does the information in this column represent a recommendation to buy or sell stocks. Cramer's writings provide insights into the dynamics of money management and are not a solicitation for transactions. While he cannot provide investment advice or recommendations, he invites you to comment on his column at jjcletters@thestreet.com.
http://biz.yahoo.com/prnews/050504/new019.html?.v=8
Press Release Source: Genzyme Corporation
Genzyme and Bone Care International Announce Merger Agreement ------------------------------------------------------ Genzyme to Acquire Bone Care, Adding Complementary Therapy to Renagel; Accelerates Commercial Entry into Earlier Stages of Chronic Kidney Disease
Wednesday May 4, 9:21 am ET
CAMBRIDGE, Mass. and MADISON, Wis., May 4 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ - News) and Bone Care International (Nasdaq: BCII - News) announced today that they have signed a definitive merger agreement under which Genzyme will acquire Bone Care in an all cash transaction valued at $33.00 per fully diluted share, or approximately $600 million, net of Bone Care's cash of $119 million.
With the close expected in the third quarter of the year, Genzyme expects the transaction to be neutral in 2005, and accretive beyond. Genzyme will provide specific advice upon completion of purchase accounting.
The acquisition of Bone Care brings Genzyme a complementary line of products and a profitable commercial organization that will strengthen and diversify Genzyme's renal business. Bone Care's Hectorol® (doxercalciferol), a line of vitamin D2 pro-hormone products, is used to treat secondary hyperparathyroidism in patients on dialysis, where it can be used in tandem with Genzyme's Renagel® (sevelamer hydrochloride) and other phosphate binders. Hectorol is available in intravenous form for patients on hemodialysis, and in oral forms primarily used by patients with earlier stage chronic kidney disease (CKD). It is the first and only vitamin D2 analog approved to treat the continuum of chronic kidney disease.
Sales of Hectorol reached $59 million for the nine months ended March 31, 2005. Based on strong third quarter sales, Bone Care increased its revenue guidance on April 26 to a range of $82-$83 million for fiscal year 2005, ending June 30, 2005.
"We are tremendously excited for the opportunity to bring these products to Genzyme," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "The addition of the Bone Care organization and the Hectorol brand will solidify and strengthen our growing renal business, while further broadening our overall product portfolio. This important therapy for patients with earlier stages of chronic kidney disease will provide Genzyme with valuable commercial experience and speed our entry into this much larger market."
Paul Berns, Bone Care's president and chief executive officer, said: "Genzyme has recognized the potential of our strong growth platform and the value our employees bring to patients, clinicians and shareholders. We believe that this merger is a tremendous opportunity to optimize Bone Care's global business potential."
Strong Strategic Fit
The use of Renagel and Hectorol are each supported by a large and growing body of clinical evidence. Both products are well positioned in the National Kidney Foundation's (NKF) K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Renagel, the only calcium-free, metal-free phosphate binder, controls serum phosphorus levels in patients with CKD on hemodialysis. The NKF's K/DOQI guidelines recommend sevelamer hydrochloride as a first-line treatment option to reduce phosphorus. Renagel has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Renagel is used by more than 350,000 people worldwide.
Hectorol capsules are a unique pro-hormone vitamin D2 analog formulation indicated for the treatment of secondary hyperparathyroidism in patients with CKD stages 3, 4, and 5. Hectorol treats secondary hyperparathyroidism, a condition that impacts a significant number of patients with earlier stages of CKD. This condition, if left untreated, can result in bone disease, muscle weakness, reduced immunity, cardiovascular disease and increased mortality. Genzyme estimates that more than 500,000 patients in the United States with CKD stage 3 and stage 4 have elevated PTH levels above K/DOQI targets.
Beyond Renagel's current indication for patients on hemodialysis (stage 5 CKD), Genzyme is developing a next generation sevelamer for use in hyperphosphatemic patients in earlier stages of chronic kidney disease. Genzyme has begun enrolling patients in a short-term clinical trial of sevelamer carbonate to evaluate the product's equivalence to Renagel, and anticipates launching a study later this year to evaluate sevelamer carbonate's potential to benefit hyperphosphatemic patients with earlier stage chronic kidney disease.
Genzyme intends to integrate Bone Care into its own renal operations in the United States. Genzyme will also begin immediate work on the registration of Hectorol outside of the United States, with particular focus on Europe and Asia. Presently, Hectorol is only sold in North America.
"This transaction provides a great strategic opportunity for Genzyme to expand our renal business further, and to raise the visibility of both product lines with nephrologists and renal patients throughout the world," said John P. Butler, president, Genzyme Renal.
In addition to Renagel, Genzyme developed and now markets Fabrazyme, an enzyme replacement therapy for Fabry disease, a degenerative disorder that can lead to kidney failure; and Thymoglobulin, a polyclonal antibody product used to treat rejection of a kidney transplant. Genzyme is also investigating future treatments focused on polycystic kidney disease, and working to improve renal patient care through support of basic research, disease awareness initiatives and treatment access programs.
Bone Care has an active development program for Hectorol and other vitamin D analogs in CKD and a range of other diseases, including psoriasis and cancers of the prostate, breast and colon.
Financial Terms
Genzyme's acquisition of Bone Care will take the form of a merger, with shareholders receiving $33.00 per share. As of March 31, 2005, Bone Care had approximately $119 million in cash and equivalents. Genzyme has access to more than $1.5 billion in cash and equivalents, including an undrawn line of credit. The transaction has been approved by the boards of directors of both companies, and is subject to approval by Bone Care's shareholders and clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to be completed in the third quarter of 2005. Genzyme will issue revised financial guidance after completion of purchase accounting.
About Renagel (sevelamer hydrochloride)
Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel.
For more information about Renagel, including complete prescribing information, please visit http://www.renagel.com.
About Hectorol® (doxercalciferol)
Hectorol® is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease and patients with stage 5 chronic kidney disease on dialysis. Hectorol® should not be given to patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity. Overdosage of any form of vitamin D, including Hectorol®, is dangerous. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The principal adverse effects of treatment of Hectorol® are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of iPTH. Oversuppression of iPTH may lead to adynamic bone syndrome.
About Bone Care
Bone Care is a specialty pharmaceutical company engaged in the discovery, development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life- threatening diseases. The company's current commercial and therapeutic focus is in nephrology, utilizing Hectorol, a novel vitamin D hormone therapy, to treat secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease. In addition to chronic kidney disease, the company is developing vitamin D hormone therapies to treat hyperproliferative disorders such as cancer and psoriasis.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with annual revenues exceeding $2 billion and more than 7,000 employees in locations spanning the globe. With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.
http://biz.yahoo.com/bw/050421/215092.html?.v=1
Press Release Source: POZEN Inc.
POZEN Hits All Primary Endpoints in Second Phase III Pivotal Trial for Trexima
Thursday April 21, 7:30 am ET
NDA Submission Scheduled for 3Q 2005
CHAPEL HILL, N.C.--(BUSINESS WIRE)--April 21, 2005--POZEN Inc. (NASDAQ: POZN - News), announced today that it achieved statistical significance for all regulatory endpoints for Trexima in the second of the two Phase III pivotal trials. Trexima(TM) is GlaxoSmithKline's (GSK) proposed brand name for the combination of sumatriptan formulated with RT Technology(TM) and naproxen sodium in a single tablet. GSK and POZEN are collaborating on the development of Trexima.
POZEN also announced that it has met with the FDA and discussed the results of both Phase III trials and other information required for the submission of the Trexima NDA. Based upon discussions at the pre-NDA meeting, POZEN believes that no additional pre-clinical or clinical trials are necessary for submission. The Trexima NDA submission is now scheduled for the third quarter of 2005.
In the second Phase III study, Trexima demonstrated superiority over the individual components on the primary endpoint and also met all the regulatory endpoints for a new migraine product. For the combination, Trexima demonstrated a superior sustained pain-free response versus naproxen (p<0.001) and versus sumatriptan (p=0.009). With respect to pain relief and the associated symptoms of nausea, photophobia, and phonophobia, Trexima was superior to placebo at 2 hours for all parameters (p=0.007 for nausea, p<0.001 for the others).
"We are obviously very pleased with the pre-NDA meeting resulting in our ability to submit the Trexima NDA early in the second half of this year," said Dr. John R. Plachetka, Chairman, President and CEO. "The team has done a remarkable job in completing the two pivotal studies in less than a year from start to finish."
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of migraine. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel Pharmaceuticals, and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our annual report on Form 10-K for the year ended December 31, 2004 under "Management's Discussion and Analysis of Financial Condition and Results of Operations." We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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Contact:
POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
or
Fran Barsky, 919-913-1044
Director, Investor Relations
CGTK has $4 in cash, no debt, and a stock price at $2.25. Anybody think its worth investing in - even after its recent failures?
TIA,
10nis
Dew,
Was the FDA panel made up of the same people (in regards to the Inamed and Mentor decisions)? I just find it interesting that the overall decisions were not the same.
Thanks,
10nis
http://biz.yahoo.com/rb/050412/health_implants.html?.v=6
Reuters
FDA Panel Rejects Silicone Breast Implants
Tuesday April 12, 6:22 pm ET
By Susan Heavey and Lisa Richwine
GAITHERSBURG, Md. (Reuters) - Inamed Corp. failed to provide convincing evidence that its silicone breast implants are safe enough to win U.S. approval and end a 13-year ban on the devices, an advisory panel narrowly ruled on Tuesday.
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Inamed shares plummeted in after-hours trading, falling 9.4 percent to $60.16 on the Inet electronic brokerage.
The advisory committee voted 5-4 against recommending approval of Inamed's implants. The Food and Drug Administration will consider the advice as it decides whether to lift sales restrictions imposed in 1992 amid concerns that leaking implants could cause long-term, disabling illness.
"I feel that (approval) is premature. I don't feel secure about the safety," said Dr. Amy Newburger, a panel member from Dermatology Consultants of Westchester in Scarsdale, New York.
Studies have failed to find a connection between silicone implants and chronic diseases such as lupus and rheumatoid arthritis. The implants can cause pain around the breast and other complications, and they can break and require repeat operations to replace them.
Fifteen months ago, the FDA rejected an application from Inamed to sell silicone breast implants and told manufacturers to collect more information about how often the devices break apart and what the consequences are. Now Inamed and rival Mentor Corp. are seeking approval to sell the silicone devices.
Inamed officials told the panel the silicone implants, widely available in other countries, were reasonably safe. In the United States, only breast cancer survivors and others needing reconstruction or implant replacements can now receive silicone implants, through clinical trials.
"We believe the risks are acceptably low," said Dan Cohen, Inamed's vice president of global government and corporate affairs. "The risks are largely related to the surgical procedure...rather than the nature of the device."
The panel's ruling followed nearly 12 hours of emotional testimony on Monday both from women who linked the implants to chronic illnesses and from others who touted them as safe and more natural-looking than saline-filled implants.
Both Inamed, which is being bought by Medicis Pharmaceutical Corp., and Mentor have said new silicone implants are more durable, and the gel is stickier and less likely to migrate.
On Wednesday, the panel will review Mentor's studies.
DNDN
New 52-week low. Anyone purchasing more at current prices or waiting for the downtrend to stop before buying more?
Thanks,
10nis
Does anyone see any upside to DSCO (Discovery Laboratories, Inc.)?
TIA,
10nis
TaxDude,
I work for one of the Big 4 and I couldn't agree with you more, however, you can thank the Enron's, HealthSouth, Worldcom's, Global Crossings, Arthur Anderson exec's for the SOX rules. Let me know if you're ever in need of any new staff.
Take care,
10nis
TaxDude,
Where do you work and what is your position?
Does anybody know anything about PSIS (Psychiatric Solutions, Inc.)? It seems like an interesting company although probably a little pricey at current levels. If anyone knows anything about them or has any opinions please express them.
TIA,
10nis
Dew... The GTCB yahoo board is fixed. Last night it was only showing the first 5 GTCB posts. I'm glad to see its back up. Nice rise in GTCB so far today...
Thank you for all of your very informative posts!!
Does anybody know what happened to the GTCB Yahoo board?
- 10nis
GTCB.....
Per Yahoo, the largest institutional investor in GTCB is Heartland Advisors "Heartland Value Plus Fund" owning 3.21%. Does anyone on this board know or work for Bill Nasgovitz (the portfolio manager)? Especially the Wisconsinites on this board. I prepared his tax return way back in 1998, however, I have lost touch with contacts at Heartland Advisors (previously Heartland Funds). I guess I'm just a little surprised by this holding in GTCB, although it definitely falls in the value category. If anyone knows anything...drop a reply.
TIA,
10nis
Anyone buying PFE or MRK today? TIA, 10nis
FYI.........
Marijuana makes blood rush to the head
21:00 07 February 2005
NewScientist.com news service
American Academy of Neurology
Neurology Journal
Smoking marijuana can affect blood flow in the brain so much that it takes over a month to return to normal. And for heavy smokers, the effects could last much longer, a new study suggests.
Regular marijuana use can harm memory and the ability to make decisions, according to Jean Cadet at the National Institute on Drug Abuse in Baltimore, Maryland, US. To find out why, he monitored the flow of blood through the brains of 54 marijuana smokers, among whom the heaviest user smoked 50 joints every day.
People who smoked cannabis had higher blood flow through their brains than non-users. Yet there was also greater resistance to the blood flow, suggesting that cannabis changes the blood vessels in the brain in a way which hinders oxygen in reaching the tissue effectively. In an attempt to compensate, extra blood is sent to that part of the brain, increasing resistance but probably failing to get enough oxygen through the vessels, Cadet suggests.
Cadet and his colleagues used an extremely sensitive non-invasive technique called transcranial Doppler sonography to "see" the blood flow through individual arteries from the head's surface.
After a month without cannabis - during which the volunteers agreed to remain in a clinic, with no access to marijuana - Cadet repeated the sonography. The resistance to blood flow of light and moderate users - who usually smoked an average of 11 and 44 joints per week, respectively - was starting to return to normal.
Neuropsychological problems
But there was no improvement observed in the heavy users, who smoked an average of 131 joints per week. "We were surprised because we'd expected that as marijuana cleared the system things would improve," says Cadet. He now wants to see if there is a link between the changes in the brain's blood flow and the extent of neuropsychological problems.
To eliminate the effect of tobacco in the joints, Cadet compared his results to those obtained from smokers, who showed normal blood flow. But, says William Notcutt of James Paget Hospital in Norfolk, UK, the longer-term effect on the brain may not have been caused by the same substance that produces the high.
"Somebody smoking 50 joints per day is getting a huge number of carcinogens from the marijuana plant," he notes. "We know the cardiovascular effect [of cannabis] is very complex and multi-factorial so it's not as simple as with other drugs. The group that needs to be studied now is people that use high quality medicinal extracts."
He adds that the results may also be different for people that only smoke marijuana occasionally, and so are exposed to lower doses of the toxic substances.
Journal reference: Neurology (vol 64, p 488)
Medicare prescription benefit to cover Viagra
Drug prescribed only when medically necessary
Tuesday, February 1, 2005 Posted: 12:04 PM EST (1704 GMT)
WASHINGTON (AP) -- Sexual performance drugs like Viagra will be covered by Medicare's new prescription benefit beginning next year, along with medications for other conditions like high blood pressure and heart disease, Health and Human Services officials said Tuesday.
And like those other drugs, prescriptions for Viagra will be tightly controlled. The law, which takes effect January 1 at a cost of more than $500 billion over a decade, says Viagra can be prescribed only when medically necessary, and in limited quantities.
"The law says if it's an (Food and Drug Administration)-approved drug and it is medically necessary, it has to be covered," said Gary Karr, spokesman for the Centers for Medicare and Medicaid Services, which administers the health insurance program for older Americans.
Since it was approved by the FDA in 1998, about 16 million men have tried Viagra, according to Pfizer, which makes the drug.
President Bush two years ago signed into law the new voluntary drug benefit, which is expected to cover the drug expenses of 11 million low-income older and disabled people. The government contends the program also could cut drug costs in half for most seniors.
Medicare issued final rules last month for the prescription program, for which low-income people begin registering in June. Other recipients are to sign up in November. The Los Angeles Times first reported Medicare's coverage of sexual performance drugs.
Conservatives say the law opens the door to precisely the kind of big government bureaucracy that they -- and Bush -- campaigned against.
There was never a discussion of what drugs would be covered during Congress's all-night debates on the issue, one analyst pointed out.
"You cannot have a universal entitlement like this without extreme micromanagement," said Robert E. Moffit, a health care analyst at the Heritage Foundation.
"Members of Congress, frankly, are not competent to make these decisions. Is Congress going to start writing prescriptions?" he added. "Micromanagement will institutionalize incompetence."
The signature component of last year's Medicare law, the prescription drug benefit, will vary widely in its impact on the 29 million older and disabled Americans that the Congressional Budget Office projects will enroll, the study said. The CBO said the average savings will be 37 percent in 2006.
Anyone holding some AXYX? I believe Dew you said you don't like AXYX's management/CEO.
I'm just curious of anyone's opinion on its recent market action (down rather significantly of late). I was thinking about buying a few shares to speculatively play the Phase IIB and Phase III results to be announced sometime before the end of Q1, but I thought I would ask before I bought. TIA.
Have a great day,
10nis
Report: Viagra may help enlarged hearts
Sunday, January 23, 2005 Posted: 4:51 PM EST (2151 GMT)
WASHINGTON (AP) -- Viagra may aid in the treatment of enlarged hearts that can result from high blood pressure, tests on animals indicate.
Plans are under way for a trial to determine if similar results occur in humans given the drug widely used to treat erectile dysfunction.
The drug, known generically as sildenafil citrate, blocked and even reversed some of the heart enlargement in mice with blood pressure stress, said researchers led by Dr. David A. Kass of the Johns Hopkins University School of Medicine.
"A larger-than-normal heart is a serious medical condition, known as hypertrophy, and is a common feature of heart failure that can be fatal," Kass said.
He said the findings "suggest possible therapies in the future, including sildenafil, which has the added benefit of already being studied as safe and effective for another medical condition" in male sexual dysfunction.
The report, in Sunday's online edition of Nature Medicine, came as no surprise to Dr. William B. White, head of the hypertension section of the University of Connecticut Health Center.
White, who was not part of Kass' research team, noted that sildenafil originally was discovered by researchers studying blood pressure and heart disease.
The drug, however, is effective only for a short time, he said. It would need to be longer acting to be useful in treating heart enlargement, White said.
Dr. Richard Devereux of Weill Cornell Medical College in New York agreed that sildenafil is too short acting to be a practical medication for heart enlargement in humans.
"But this still constitutes a clue that I personally find very exciting and potentially important," he said in a telephone interview.
The finding can propel a search for compounds related to sildenafil that are longer acting and have similar heart benefits, said Devereux, who did not participate in the new research.
Kass said sildenafil blocks the action of an enzyme called PDE5A, which helps break down a molecule known as cyclic GMP. This molecule helps the heart resist stresses and enlargement, researchers said, so protecting it from being broken down allows it to continue the heart-healthy work.
Sildenafil has proved useful in erectile dysfunction because PDE5A also is involved in the relaxation of blood vessels in the penis.
In one experiment cited in Nature Medicine, the Hopkins team induced heart pressure stress in mice by constricting the main artery carrying blood from the heart.
After as long as nine weeks, scientists found that the mice that consumed sildenafil in their food developed only about half as much heart enlargement as those that did not get the drug.
Researchers also found that the mice receiving sildenafil developed 67 percent less fibrous tissue in their hearts and that the treated mice had smaller hearts with better heart function.
In a different experiment, mice that already had enlarged hearts were given sildenafil for two weeks. The researchers said the muscle growth nearly disappeared in those mice, while the hearts continued to enlarge in animals that were not given the drug. Heart function in the mice improved after the treatment.
In both cases, the mice were given 100 milligrams of sildenafil per kilogram of weight per day. The researchers said that produced blood levels similar to those in doses given to humans.
The researchers stressed that the makers of Viagra had no involvement in the design or support of the research.
Their work was funded by the National Institutes of Health, the Peter Belfer Laboratory for Heart Failure Research, Uehara Memorial Foundation, American Heart Association, American Physiological Society and Bernard Family Foundation.
OT.....
U.S. military nixed gay ‘aphrodisiac' weapon
Another idea: ‘Severe and lasting halitosis’ to sniff out enemy
Updated: 11:23 a.m. ET Jan. 17, 2005WASHINGTON - The U.S. military rejected a 1994 proposal to develop an “aphrodisiac” to spur homosexual activity among enemy troops but is hard at work on other less-than-lethal weapons, defense officials said Sunday.
The idea of fostering homosexuality among the enemy figured in a declassified six-year, $7.5 million request from a laboratory at Wright Patterson Air Force Base in Ohio for funding of non-lethal chemical weapon research.
The proposal, disclosed in response to a Freedom of Information request, called for developing chemicals affecting human behavior “so that discipline and morale in enemy units is adversely affected.”
“One distasteful but completely non-lethal example would be strong aphrodisiacs, especially if the chemical also caused homosexual behavior,” said the document, obtained by the Sunshine Project. The watchdog group posted the partly blacked-out, three-page document on its Web site.
Rejected out of hand
Lt. Col. Barry Venable of the Army, a Defense Department spokesman, said, “This suggestion arose essentially from a brainstorming session, and it was rejected out of hand.”
The Air Force Research Laboratory also suggested using chemicals that could be sprayed on enemy positions to attract stinging and biting bugs, rodents and larger animals.
Another idea involved creating “severe and lasting halitosis” to help sniff out fighters trying to blend with civilians.
The U.S. military remains committed to developing less-than-lethal weapons that pass stringent legal reviews and are consistent with international treaties, said Captain Dan McSweeny of the Marine Corps, a spokesman for the Pentagon unit spearheading their introduction.
“We feel it’s very important to offer our deployed service members and their commanders a greater range of options in dealing with increasingly complex operational environments,” said McSweeny, of the Joint Non-Lethal Weapons Directorate.
Dew,
What kind of target price do you put on OSIP?
Thanks,
10nis
Press Release Source: Cortex Pharmaceuticals, Inc.
Cortex Announces $11.26 Million Private Placement
Wednesday December 15, 2:02 pm ET
Funds to Accelerate CX717 Clinical Development
IRVINE, Calif.--(BUSINESS WIRE)--Dec. 15, 2004--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) announced that it has entered into a definitive agreement with new and existing institutional investors relating to a private placement of $11.26 million of securities through the sale of 4,233,333 shares of common stock at $2.66 per share. The agreement also includes five-year warrants to purchase an additional 2,116,666 shares of the Company's common stock at an exercise price of $3.00 per share by the investors. Rodman & Renshaw, LLC served as the placement agent for the transaction.
"Roger Stoll, Ph.D., Chairman and CEO of Cortex stated, "With this financing, Cortex for the first time in its history has the kind of financial resources that will allow us to accelerate the development of CX717 and a follow-on compound from the low impact chemistry group. We can also continue to develop a potential high impact compound and exploit their ability to elevate BDNF, a brain growth factor. If we can get several compounds into clinical trials we can optimize the chance for success for Cortex. We intend to add another three to four healthcare professionals to our staff over the next six months."
The securities were offered to accredited investors in reliance on an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The securities have not been registered under the Securities Act or any state securities laws and the securities may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. In connection with the offering, Cortex has agreed, subject to certain terms and conditions, to file a registration statement under the Securities Act covering the resale of the shares purchased and shares issuable upon exercise of the warrants. This press release does not and will not constitute an offer to sell or the solicitation of an offer to buy shares or warrants and is being issued under Rule 135c under the Securities Act.
About Cortex Pharmaceuticals:
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE® compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer's disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology.
Phase II result leak or just some buying of GENR shares?