Short List (comments).
OXGN (neutral or short) updated to speculative trading
May 11, 2011 by BiotechInvest
Today is a red day for almost all biotech stocks but OXGN is green with almost +25% plus.
OXGN has Shares Out. 9.5M but today volume was 16M. How it is possible? It seems like that it was "day trader" game and winners were only who leave this game at right moment. Funds and institutions are not players here, only biotech gamblers did all this volume.
OXGN was pumped only by these "news":
"Today MomentumHunter.com announces seven stocks to watch closely: Raptor Technology (OTCBB: RAPT), Barrista Coffee Co. (BCCI), FBC Holdings (FBCD), Oxigene (OXGN), Lithium Exploration (LEXG), Uniontown Energy (UTOG), Jammin Java (JAMN), Sirius (SIRI)."
So, what is this company? And what the news biotech investors are waiting?
"OXiGENE, Inc. (Nasdaq:OXGN - News), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, will report first quarter 2011 results on Thursday, May 12, 2011. A conference call and webcast hosted by OXiGENE management will begin at 4:30 pm EDT (1:30 p.m. PDT)."
This company indeed has phase III trial "Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer"
The purpose of the study is to determine the safety and efficacy of combretastatin combined with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC).
Primary Outcome Measures:
* Overall survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
* To evaluate the safety and tolerability of the triplet combretastatin+paclitaxel+carboplatin combination [ Time Frame: one year ] [ Designated as safety issue: Yes ]
CA4P + carboplatin + paclitaxel
Intervention: Drug: combretastatin A-4 phosphate (CA4P)
Drug: combretastatin A-4 phosphate (CA4P)
CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
2: Active Comparator
Paclitaxel 200mg/m squared on DAy 1 followed by carboplatin 6 AUC on Day 1 for 6 cycles
* Drug: paclitaxel
* Drug: carboplatin
200mg/m squared on Day 1
6 AUC on Day 1 following paclitaxel
Other Name: Paraplatin
Estimated Enrollment: 180
Study Start Date: July 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
In March 21, 2011 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has received minutes from a Type C meeting held on March 16, 2011, between OXiGENE and the US Food and Drug Administration (FDA) to discuss next steps in the development of ZYBRESTAT as a potential treatment for anaplastic thyroid cancer (ATC).
As the company anticipated, the FDA indicated at the meeting that the data from the FACT trial are suggestive of possible clinical activity that may warrant continued development, and that to seek regulatory approval, OXiGENE should plan to conduct an additional clinical trial with a survival endpoint. The FDA also confirmed that, as the company had expected, the Special Protocol Agreement (SPA) that had been agreed upon at the start of the study is no longer in effect.
"We appreciate the candid discussions and constructive feedback we received from the FDA representatives," said Peter Langecker, Chief Executive Officer of OXiGENE. "We believe that the totality of the data, which showed that of 84 ATC patients treated with ZYBRESTAT, 20 (approximately 24%) survived one year or longer as compared to a historical rate of less than 10%, provides a compelling basis for further study."
Dr. Langecker added: "We continue to be encouraged by the outcomes in all of our clinical studies to date, including the ATC study, and are reviewing our options to further develop our VDA therapies and the additional funding that would be needed through strategic partnerships and equity financing."
The company has submitted an abstract and expects to present the final data from the FACT study, an 80-patient, randomized, controlled trial of ZYBRESTAT in combination with carboplatin and paclitaxel in patients with ATC at ASCO in June 2011."
Phase 2/3 Study Results
The FACT Study is a controlled, randomized Phase 2/3 study investigating the addition of ZYBRESTAT (fosbretabulin tromethamine, or CA4P) to chemotherapy (carboplatin and paclitaxel) in patients with anaplastic thyroid cancer (ATC). The FACT study initially anticipated enrollment of 180 patients. Enrollment in the study was truncated and a total of 80 patients were enrolled with 55 in the ZYBRESTAT + chemotherapy arm and 25 in the chemotherapy arm. The treatment arms were well balanced with regard to key patient characteristics except for a greater percentage of females in the control arm. Patients on the study arm received ZYBRESTAT each week and chemotherapy on day 2 of treatment every three weeks. Patients on the control arm received chemotherapy every three weeks. Patients on the study arm could elect to receive CA4P alone as maintenance therapy after completing 6 cycles of therapy. Maintenance therapy continued until disease progression.
Key Study Results
-- Median survival time was 5.1 months for patients who received ZYBRESTAT
and chemotherapy, and 4.1 months for patients who received chemotherapy
alone. Hazard ratio (95% CI): 0.71 (0.42, 1.22).
-- At one year, 23% of patients whose treatment included ZYBRESTAT were
alive compared to 9% of patients treated with chemotherapy alone.
-- At six months, 48% of patients whose treatment included ZYBRESTAT were
alive compared to 37% of patients treated with chemotherapy alone.
-- In patients less than 60 years of age, median survival time was 10.9
months for patients who received ZYBRESTAT and chemotherapy, and 3.1
months for patients who received chemotherapy alone. Hazard ratio (95%
CI): 0.38 (0.16, 0.88).
-- In patients with stage IV C disease, median survival time was 5.0 months
for patients who received ZYBRESTAT and chemotherapy, and 3.8 months for
patients who received chemotherapy alone. Hazard ratio (95% CI): 0.63
-- In patients with tumor sizes of greater than 6 cm, median survival time
was 5.7 months for patients who received ZYBRESTAT and chemotherapy, and
3.9 months for patients who received chemotherapy alone. Hazard ratio
(95% CI): 0.51 (0.22, 1.19).
-- The improvement in survival in patients with stage IV C disease and with
tumor sizes of greater than 6 cm whose treatment included ZYBRESTAT
suggests greater antitumor activity of ZYBRESTAT and chemotherapy in
more advanced tumors.
Well, when I see that new experimental anti-cancer drug is mixed in cocktail with 2 old anti-cancer drugs it's already "red flag" for me.
Why not test it as a single entity? Is it too weak to show any efficacy alone?
And what is this combretastatins?
"The combretastatins are a class of natural stilbenoid phenols. A variety of different natural combretastatin molecules are present in the bark of Combretum caffrum, commonly known as South African Bush Willow. Despite having a similar name combretastatin is unrelated to statins, a family of cholesterol lowering drugs."
Members of the combretastatin family possess varying ability to cause vascular disruption in tumors. Combretastatin binds to the β-subunit of tubulin at what is called the colchicine site, referring to the previously discovered vascular disrupting agent colchicine. Inhibition of tubulin polymerization prevents cancer cells from producing microtubules. Microtubules are essential to cytoskeleton production, intercellular movement, cell movement, and formation of the mitotic spindle used in chromosome segregation and cellular division. The anti-cancer activity from this action results from a change in shape in vasculature endothelial cells. Endothelial cells treated with combretastatin rapidly balloon in shape causing a variety of effects which result in necrosis of the tumor core. The tumor edge is supported by normal vasculature and remains, for the most part, unaffected. As a result it is likely that any therapeutic use will involve a combination of drugs or treatment options."
Wait a minute... Taxol (or paclitaxel) has a similar mechanisms action i.e. it stabilizes microtubules and stop cancer cells division
(Paclitaxel-treated tumor cells arrest in the G2-M phase of the cell cycle, leading to apoptotic cell death).
So, OXGN ZYBRESTAT is just another chemotherapy drug. It inhibits tubulin polymerization i.e. microtubule formation.
Cisplatin and carboplatin, as well as oxaliplatin, interact with DNA, akin to the mechanism of alkylating agents.
So, OXGN just add one more chemotherapy drug to cocktail of 2 old chemotherapy drugs... It seems like a trick to fool investors.
OXGN tests CA4P + carboplatin + paclitaxel against active comparator carboplatin + paclitaxel.
Since CA4P acts similar to paclitaxel (prevent microtubule polymerization) they should increase paclitaxel dose in Arm 2
Arm1 is CA4P 60mg/m2 + Paclitaxel 200mg/m2 followed by carboplatin 6 AUC
Arm2 is Paclitaxel 200mg/m2 followed by carboplatin 6 AUC
So, it was possible to increase the Paclitaxel to 250 mg/m2 in Arm 2.
May be we have some pumped "balloon" here and "investomadness" attack. Good moment to short this company.
Disclosure: I shorted OXGN 20k at average $5.09.
May 12, 2011 by BiotechInvest
I see now why all this noise. OXGN just need money and wanted to pump stock price before next dilution. Well, it's wise tactic for OXGN management. Now they can offer the stock at $4 easy.
"At March 31, 2011, OXiGENE had cash, cash equivalents and restricted cash of approximately $2.7 million, compared with approximately $4.7 million at December 31, 2010. During the three months ended March 31, 2011 the Company raised approximately $1,625,000 through sales of its common stock under an at-the-market equity offering sales agreement with McNicoll, Lewis & Vlak, which was executed in July 2010. During the period from April 1, 2011 through May 2, 2011, OXiGENE raised approximately $3,000,000 through this same sales agreement."
May 17, 2011 by BiotechInvest
OXGN is in volatile mode now, all OXGN investors are waiting for good news from Chicago 2011 Annual Meeting (June 3 - 7). So, it's a good opportunity to play "volatile game" with OXGN i.e. buy, sell, short and etcetera...
May 20, 2011 by BiotechInvest
Sold OXGN because some report cooled this gambling. This time Adam F from TheStreet was negative about OXGN and investors believed him.
"At this year's ASCO meeting, a final survival analysis will be presented from the "FACT" phase II/III study of Zybrestat in patients with anaplastic thyroid cancer (ATC). The median overall survival for patients treated with Zybrestat and chemotherapy is 5.2 months compared to 4 months for patients treated with chemo alone. This equates to a 35% reduction in the risk of death favoring Zybrestat, although the survival benefit is not statistically significant, according to a research abstract released Wednesday evening.
While the survival trend is positive, the Zybrestat result is no different than what Oxigene reported from an earlier survival analysis from the same thyroid cancer trial last September.
These data are not good enough to allow Oxigene to seek regulatory approval for Zybrestat. In March, Oxigene said it must conduct a new clinical trial of Zybrestat in thyroid cancer following a meeting with the U.S. Food and Drug Administration."
Will monitor OXGN close to event date i.e.
FACT (Fosbretabulin in Anaplastic Cancer of the Thyroid) Presentation Details:
Oral Presentation Title: A randomized phase II/III trial of a tumor vascular disrupting agent fosbretabulin tromethamine (CA4P) with carboplatin (C) and paclitaxel (P) in anaplastic thyroid cancer (ATC): Final survival analysis for the FACT trial
Presenter: Julie A Sosa, MD, Yale University School of Medicine
Session Title: Head and Neck Cancer
Date: Monday, June 6, 2011
Session Time: 3:00PM - 6:00PM CDT
Location: McCormick Place S406
FALCON (Fosbretabulin in Advanced Lung Oncology) Poster Details:
Poster Title: A randomized phase 2 trial of a vascular disrupting agent (VDA) fosbretabulin tromethamine (CA4P) with carboplatin (C), paclitaxel (P), bevacizumab (B) in stage 3B/4 non-squamous non-small cell lung cancer (NSCLC): Analysis of safety and activity of the FALCON trial
Presenter: Edward B. Garon, MD, UCLA School of Medicine
General Poster Session, Lung Cancer Track
Abstract #7559, Poster Board #34G
Date: Saturday, June 4, 2011
Session Time: 2:00PM - 6:00PM CDT
Location: McCormick Place Hall A
Will we see the "investomadness" attack before June 4 (Saturday)? Some biotech gamblers should start OXGN buying 2-3 days before first presentation i.e. in June 2-3. It will be funny to catch this wave and then short OXGN.