Making $$ in the Market
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
hang on!!!
Shake,,Shake,,,Shake...
Strong Morning @ NEPH0 up 26%!
Another great pick Sheff-WOW!
GLTA
Investor 100
Thanks Investor 911
Perhaps the Japanese government is contracting with HEB for help!
This flu is terrible news for all of us but companies like HEB will be called upon to help fight the good fight!
GLTA
Investor 100
http://www.mffais.com/heb
Note: Most Wall Street investment firms do not own /trade stock below $5 however I would expect that to change with bigger money /players at the table!
GLTA
Investor 100
Impressive Article Sheff!
You have provided interesting DD on this stock that clearly results with definitive solutions for all hospitals.
Image the number of lives saved in hospitals if this water filtration system was installed- WOW.
FDA stamp of approval would clearly create more excitement and most importantly save lives!
Thanks for sharing this information!
Hold 5K shares.
Investor 100
Solid Day @ HEB!
Buy Volume: 18,359,584
Sell Volume: 14,048,722
Holding: 5,011,540
Last stock purchase today was 36,200 shares @ 3.72 ( $134K )!
Thanks to all for their solid DD!
GLTA
Investor 100
I agree totally fourkids9 pets + a think we'll see a partnership or buy-out when the dust settles...big drug has to be watching this stock just like us!
GLTA
Investor 100
My guess after hours: IMO
1) FDA approval.
2) Japan + Italy govt announce vaccine orders
3) Partnership announcement with bi drug company.
4) None of the above
Congrats to all + great DD from all!
Investor 100
I agree with this comment given the positive news and now global exposure this company has received makes this a real possibility!
Big drug companies have probably already taken notice!!
GLTA
Investor 100
Up 14% Today!
GL
Investor 100
Thanks for sharing investor 911!
I will check it out!
Investor 100
Swine Flu Index Back on the Radar
* On Wednesday June 3, 2009, 12:09 pm EDT
The W.H.O. is near declaring the H1/N1 virus a pandemic, but a hepatitis study drove the Swine Flu Index on Wednesday.
Swine flu fears coverage has abated somewhat in the media, but the World Health Organization suggested this week that it may classify the threat as a worldwide pandemic. To date, 64 countries have been affected by the virus. Select swine flu stocks are flying today, although H1/N1 virus treatments cannot be given credit. Dynavax Technologies (NASDAQ: DVAX - News) reported positive Phase III data for its hepatitis B vaccine, sending the stock up by more than 36%. Overall, the sector is mixed, but some of its peers are following by as much as 15%.
As a whole the Swine Flu and Bird Flu Stocks Index is up by 5.5%. It is now beating the S&P 500 by 33.5% over the last month.
AVI BioPharma (NASDAQ: AVII - News) and Hemispherx Biopharma (AMEX: HEB - News) are both following Dynavax higher by more than 14% today. Both are advancing to new 52-week highs.
Generex Biotechnology (NASDAQ: GNBT - News), Quidel (NASDAQ: QDEL - News), and Gilead Sciences (NASDAQ: GILD - News) are all trading higher by more than 4%.
Approximately half of the Swine Flu Index is in negative territory, led by BioCryst Pharmaceuticals (NASDAQ: BCRX - News), which is down -3%.
Other losers include Sanofi-Aventis (NYSE: SNY - News), GlaxoSmithKline (NYSE: GSK - News), and Novavax (NASDAQ: NVAX - News).
As of this writing the Swine Flu and Bird Flu Stocks Index is in the top-five performing tickerspy Indexes over the last month, gaining 40.2%.
Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.
Looks positive Sheff!
Initial block of 5K @ .57.
Like our chances based upon the DD information.
GLTA
Investor 100
Terrific..hiring in an recessionary economy...like it!
Thanks.
I-100
Thanks Sheff!
The potential looks terrific given the DD!
Took first position today with 5K shares @ .57
GLTA
Investor 100
Thanks Sheff!
It has been a heck of a ride thus far!
Hope you joined us :)
GLTA
Investor 100
NP
GL
I-100
Rock solid day @ HEB
Bases are forming..at the $2.50 price range...
Should continue until the news comes out...
GL
Investor 100
Great recommendation @ Sheff!
I follow Sheff on his board and he knows the bio- stocks!
Good choice- mention me too!
Investor 100
Watching for entry Sheff.
Watching to take initial position into NEPH.
Sheff you suggest an entry price?
I like the odds on this one- thanks!
Holding 10K @ HEB 1K @ KERX
GL
Investor 100
Multiple applications investor911!
My Dd tells me that HEB offers two significant applications which bodes well for those that want to trade the stock short term as well as those that are long term holders.
There is no coincidence that two governments ( Japan / Italy ) has taken a huge interest in this company and its products specifically targeting the flu arena!
Should bode well for those that hold this stock ( IMHO)
GL
Investor 100
Good Run @ HEB today!
Buy Volume: 13.7M
Sell Volume: 10.6M
Holding: 1.62M
Blocks of 17K-14K-10K-8K ....last 5 minutes..WOW
Should be interesting AH and pending announcement!
GLTA
Investor 100
I am in full agreement!
Terrific board with some real deal posters!
Kudos to all and much success with HEB!
Investor 100
It was a great day @ HEB!
Buy Volume: 13.7M
Sell Volume: 10.6M
Holding: 1.62M
Blocks of 17K-14K-10K-8K ....last 5 minutes..WOW
Should be interesting AH and pending announcement!
GLTA
Investor 100
Not til the fat lady sings (LOL)
Holding all shares for announcement!
GL
Investor 100
Added more shares on the slight dip!
GLTA
Investor 100
Over 650,000 more shares bought than sold!
GLTA
Investor 100
Almost 500K more buys than sells!
More folks buying then selling at the moment which is to be expected given the pending decision.
Solid base above $2.00 this afternoon.
GLTA
Investor 100
Solid afternoon @ HEB!
4m shares trading in the past 15 minutes as rumors spread on pending FDA approval AH. Stock climbs to $2.22.
Holding until approval!
GLTA
Investor 100
Thanks Sheff...
What is a good entry point into BVTI?
Looking to add an initial position!
Thanks
Investor 100
Thanks Sheff-Solid PR @ HEB!
This stock is both a short and long term hold given the recent news and potential opportunity with the swine flu situation.
Adding on any dips as the upward potential (IMHO) is terrific!
GLTA
Investor 100
Thanks for the Update Sheff!
Lots of good information for Monday to then make another choice move...hmmm
Holding HEB for FDA announcement.
GLTA
Investor 100
Sheff- Whats in your playbook?
Sold 7500 shares of KERX at $1.40 ( Double )
Hold 6K shares of HEB.
GLTA
I-100
I posted TELK this weekend!
Telik Presents Results at ASCO From ASSIST-5 Trial of TELCYTA in Platinum Refractory and Resistant Ovarian Cancer.
Sheff, another one of your play selections last week!
PALO ALTO, Calif., May 31 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) today announced presentation at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, of results from the ASSIST-5 Phase 3 randomized, multinational study of TELCYTA® (canfosfamide HCl) in combination with pegylated liposomal doxorubicin (PLD) vs. PLD alone in second-line therapy in platinum refractory or resistant ovarian cancer.
Study Design: Patients with platinum refractory or resistant ovarian cancer (platinum refractory, primary platinum resistant, secondary platinum resistant) by standard GOG criteria, with measurable disease were eligible for enrollment in the trial. A total of 125 patients at sites in the USA (44), Brazil (15), Belgium (8) and UK (6) were randomized with a 1:1 allocation to receive either TELCYTA in combination with PLD (administered IV at doses of 1000 mg/m2 and 50 mg/m2, respectively, every four weeks), or PLD alone (at 50 mg/m2 every four weeks). Patients were treated until tumor progression or unacceptable toxicity. Tumor assessments were conducted every 2 cycles or 8 weeks.
The trial design provided for the enrollment of 244 patients. The trial was interrupted by a clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. As a result, 35 patients (21 on the combination treatment and 14 on PLD alone) were discontinued from their study treatment(s) and did not complete their assigned per protocol therapy. Although enrollment was permitted after the release of the clinical hold, Telik decided not to enroll additional patients, which impacted the powering of the study.
Patient Demographics: The treatment arms were well-balanced for patient demographics and key ovarian cancer disease characteristics, including age, ECOG Performance Status, presence of bulky disease and history of prior taxane therapy. A greater number of patients (13, 20%) had platinum refractory disease on the TELCYTA plus PLD arm compared to (8, 13%) with the PLD arm.
Efficacy Results: On an Intent-to-Treat (ITT) basis for the entire 125 enrolled patients, including those affected by the hold, the median progression-free survival (PFS) was 5.6 months on the TELCYTA plus PLD arm compared to 3.7 months on the PLD control arm, p=0.7243 and hazard ratio (HR)=0.92. The overall response rate (ORR) as assessed by RECIST was 12%, including one complete response (CR) for the TELCYTA plus PLD arm vs. 8% for the PLD control arm. The PLD control arm treatment outcomes were consistent with that reported previously in the evidence-based literature of randomized trials in platinum refractory and resistant ovarian cancer in both safety and efficacy.
Efficacy Results - Prespecified Analysis: Of the 125 patients in the ITT population, a pre-specified analysis was conducted for 75 patients (60% of study participants) with platinum refractory or primary platinum resistant disease, including 40 patients (53%) on the TELCYTA plus PLD arm and 35 patients (47%) on the PLD control arm. The median PFS of these patients was 5.6 months for the TELCYTA plus PLD arm compared to 2.9 months for the PLD control arm, p=0.0425 and HR=0.55. The response rate was 15% including one CR for the TELCYTA plus PLD arm vs. 6% for the PLD control arm.
Although the study was not powered for survival, median survival in the platinum refractory and primary platinum resistant population showed a positive trend in survival for the TELCYTA plus PLD arm (11.8 months) vs. PLD alone (7.8 months). In addition, the TELCYTA plus PLD arm achieved shorter median time to response (2.8 vs. 5.5 months), and longer median duration of stable disease (7.4 vs. 4.1 months, HR=0.49, p=0.0439).
As in the overall ITT population, compared with the PLD control arm, the TELCYTA plus PLD arm had a greater proportion of patients with a less favorable prognosis including more platinum refractory patients (13, 33% vs. 8, 23%) and lower prior best response rate (defined as CR plus PR) to platinum agents (17, 43% vs. 22, 63%).
Safety Results: The most common, non-hematologic adverse events, including nausea, fatigue, vomiting, and constipation, were similar in incidence and severity in both arms. In addition, 17% Grade 2-3 stomatitis and 9% Grade 2-3 palmar-plantar erythrodysesthesia (PPE) were observed in the TELCYTA plus PLD arm, compared to 23% Grade 2-3 stomatitis and 21% Grade 2-3 PPE in the PLD control arm. Grade 4 PPE (2%) was only observed in the PLD control arm. TELCYTA may ameliorate the incidence and severity of stomatitis and PPE known to be associated with PLD. There was a higher incidence of hematologic adverse events in patients on the TELCYTA plus PLD arm (66% vs. 44%). The hematologic adverse events were manageable with dose reductions and/or growth factor support in both treatment arms.
About Platinum Refractory and Resistant Ovarian Cancer
Platinum refractory or primary platinum-resistance is defined as those patients whose disease fails to respond or relapses within 6 months of completion of initial platinum-based treatment. Secondary platinum resistance is defined as those patients whose disease relapses after 6 months of completion of therapy and fails a re-induction platinum-based regimen.
About Telik
Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer and inflammatory diseases. The company's most advanced investigational drug candidates in clinical development are TELINTRA®, a modified glutathione analog for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy, and TELCYTA, a tumor-activated prodrug for the treatment of advanced ovarian cancer 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.
This press release contains "forward-looking" statements. These include statements concerning the potential for TELCYTA to treat ovarian cancer, the effectiveness of TELCYTA in combination with PLD and in patients under certain platinum refractory and platinum resistant conditions, and the effectiveness of TELCYTA upon stomatitis and PPE associated with PLD. These forward-looking statements are based upon Telik's current expectations. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including the risks associated with clinical trials and the interpretation of resulting data. Detailed information regarding these and other 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, 2009. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
Thanks Sheff!
Have a great week and make some money!
Keep those lost of Air France in your prayers ( 228 folks)
GLTA
Investor 100
Pre-Market Shows Strong MOMO- Sheff!
KERX: $1.71 +115%
HEB: $1.95 +15%
CYCC: $1.00 +5%
TELK: .67 Even
CRGN: $1.90 +42%
IMMU: $2.50 Even
CTIC: $1.45 +1%
Sheff you have any others to add or recommended plays?
Could be a great week to make some money!
GLTA
Investor 100
Too funny Sheff!
I-1oo
Upcoming FDA drug approvals.
Sheff, borrowed from another board forum which might be of interest added information.
Investor 100
Symbol Company
Drug FDA Deadline
SLXP Salix Pharmaceuticals
Sanvar 5/19/2009
HEB Hemispherx BioPharma Ampligen
SOON
ACUS Acusphere
Imagify 5/31/2009
ABIO ARCA biopharma
Gencaro 5/31/2009
DSCO Discovery Laboratories
Surfaxin 6/2/2009
BDSI BioDelivery Sciences International Onsolis 6/15/2009
SVNT Savient Pharmaceuticals KRYSTEXXA
6/16/2009
SPPI Spectrum Pharm Zevalin
7/2/2009
DDSS Labopharm
trazodone 7/18/2009
TSPT Transcept Pharmaceuticals Intermezzo
7/30/2009
ADLS Advanced Life Science cethromycin
7/31/2009
CTIC Cell Therapeutics
pixzntrone 12/1/2009
VION Vion Pharmaceuticals Onrigin
12/12/2009
AMRN Amarin Corporation AMR101 Phase
III
OGXI OncoGenx Pharmaceuticals OGX-011 Phase
III
ANPI Angiotech Pharmaceuticals TAXUS
Researching
Telik Presents Results at ASCO From ASSIST-5 Trial of TELCYTA in Platinum Refractory and Resistant Ovarian Cancer.
Sheff, another one of your play selections last week!
PALO ALTO, Calif., May 31 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) today announced presentation at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, of results from the ASSIST-5 Phase 3 randomized, multinational study of TELCYTA® (canfosfamide HCl) in combination with pegylated liposomal doxorubicin (PLD) vs. PLD alone in second-line therapy in platinum refractory or resistant ovarian cancer.
Study Design: Patients with platinum refractory or resistant ovarian cancer (platinum refractory, primary platinum resistant, secondary platinum resistant) by standard GOG criteria, with measurable disease were eligible for enrollment in the trial. A total of 125 patients at sites in the USA (44), Brazil (15), Belgium (8) and UK (6) were randomized with a 1:1 allocation to receive either TELCYTA in combination with PLD (administered IV at doses of 1000 mg/m2 and 50 mg/m2, respectively, every four weeks), or PLD alone (at 50 mg/m2 every four weeks). Patients were treated until tumor progression or unacceptable toxicity. Tumor assessments were conducted every 2 cycles or 8 weeks.
The trial design provided for the enrollment of 244 patients. The trial was interrupted by a clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. As a result, 35 patients (21 on the combination treatment and 14 on PLD alone) were discontinued from their study treatment(s) and did not complete their assigned per protocol therapy. Although enrollment was permitted after the release of the clinical hold, Telik decided not to enroll additional patients, which impacted the powering of the study.
Patient Demographics: The treatment arms were well-balanced for patient demographics and key ovarian cancer disease characteristics, including age, ECOG Performance Status, presence of bulky disease and history of prior taxane therapy. A greater number of patients (13, 20%) had platinum refractory disease on the TELCYTA plus PLD arm compared to (8, 13%) with the PLD arm.
Efficacy Results: On an Intent-to-Treat (ITT) basis for the entire 125 enrolled patients, including those affected by the hold, the median progression-free survival (PFS) was 5.6 months on the TELCYTA plus PLD arm compared to 3.7 months on the PLD control arm, p=0.7243 and hazard ratio (HR)=0.92. The overall response rate (ORR) as assessed by RECIST was 12%, including one complete response (CR) for the TELCYTA plus PLD arm vs. 8% for the PLD control arm. The PLD control arm treatment outcomes were consistent with that reported previously in the evidence-based literature of randomized trials in platinum refractory and resistant ovarian cancer in both safety and efficacy.
Efficacy Results - Prespecified Analysis: Of the 125 patients in the ITT population, a pre-specified analysis was conducted for 75 patients (60% of study participants) with platinum refractory or primary platinum resistant disease, including 40 patients (53%) on the TELCYTA plus PLD arm and 35 patients (47%) on the PLD control arm. The median PFS of these patients was 5.6 months for the TELCYTA plus PLD arm compared to 2.9 months for the PLD control arm, p=0.0425 and HR=0.55. The response rate was 15% including one CR for the TELCYTA plus PLD arm vs. 6% for the PLD control arm.
Although the study was not powered for survival, median survival in the platinum refractory and primary platinum resistant population showed a positive trend in survival for the TELCYTA plus PLD arm (11.8 months) vs. PLD alone (7.8 months). In addition, the TELCYTA plus PLD arm achieved shorter median time to response (2.8 vs. 5.5 months), and longer median duration of stable disease (7.4 vs. 4.1 months, HR=0.49, p=0.0439).
As in the overall ITT population, compared with the PLD control arm, the TELCYTA plus PLD arm had a greater proportion of patients with a less favorable prognosis including more platinum refractory patients (13, 33% vs. 8, 23%) and lower prior best response rate (defined as CR plus PR) to platinum agents (17, 43% vs. 22, 63%).
Safety Results: The most common, non-hematologic adverse events, including nausea, fatigue, vomiting, and constipation, were similar in incidence and severity in both arms. In addition, 17% Grade 2-3 stomatitis and 9% Grade 2-3 palmar-plantar erythrodysesthesia (PPE) were observed in the TELCYTA plus PLD arm, compared to 23% Grade 2-3 stomatitis and 21% Grade 2-3 PPE in the PLD control arm. Grade 4 PPE (2%) was only observed in the PLD control arm. TELCYTA may ameliorate the incidence and severity of stomatitis and PPE known to be associated with PLD. There was a higher incidence of hematologic adverse events in patients on the TELCYTA plus PLD arm (66% vs. 44%). The hematologic adverse events were manageable with dose reductions and/or growth factor support in both treatment arms.
About Platinum Refractory and Resistant Ovarian Cancer
Platinum refractory or primary platinum-resistance is defined as those patients whose disease fails to respond or relapses within 6 months of completion of initial platinum-based treatment. Secondary platinum resistance is defined as those patients whose disease relapses after 6 months of completion of therapy and fails a re-induction platinum-based regimen.
About Telik
Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer and inflammatory diseases. The company's most advanced investigational drug candidates in clinical development are TELINTRA®, a modified glutathione analog for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy, and TELCYTA, a tumor-activated prodrug for the treatment of advanced ovarian cancer 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.
This press release contains "forward-looking" statements. These include statements concerning the potential for TELCYTA to treat ovarian cancer, the effectiveness of TELCYTA in combination with PLD and in patients under certain platinum refractory and platinum resistant conditions, and the effectiveness of TELCYTA upon stomatitis and PPE associated with PLD. These forward-looking statements are based upon Telik's current expectations. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including the risks associated with clinical trials and the interpretation of resulting data. Detailed information regarding these and other 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, 2009. Telik does not undertake any obligation to update forward-looking statements contained in this press release.