Pharmaceutical Headlines for June 6, 2011 ( Monday ).
• Can-Fite BioPharma Signed an Agreement to Spin off Its Ophthalmology Activities to a US Based Public Company More...
• Constellation Pharmaceuticals Raises $15 Million in Additional Funding More...
• Grifols Announces the Completion of its Acquisition of Talecris Biotherapeutics (TLCR) and the Listing of its ADSs on NASDAQ More...
• Generex Biotechnology Corporation (GNBT) Announces Mutual Decision Not to Proceed with Global Medical Direct Acquisition More...
• Emergent BioSolutions (EBS) Acquires Late-Stage Monoclonal Antibody Cancer Therapy from TenX Biopharma More...
• Biomedical Advanced Research and Development Authority (BARDA) Exercises Options With Cangene Corporation (CC:CNJ) Worth US$61 Million Under Botulism Antitoxin Supply Contract More...
• Cellectis BioResearch and VitamFero Collaborate to Develop Vaccines against Parasitic Infection More...
• Waters Corporation (WAT) and PREMIER Biosoft International Announce Collaboration for Advancing Lipidomics Research More...
• GTx, Inc. (GTXI) Announces Agreement with FDA on Phase III Clinical Development Plan Evaluating Ostarine(TM) (GTx-024) for the Prevention and Treatment of Muscle Wasting in Patients with Non-Small Cell Lung Cancer More...
• Elite Pharmaceuticals, Inc. (ELI) Announces Manufacturing and Supply Agreement With Mikah Pharma, LLC More...
• AVI BioPharma, Inc. (AVII) Names Ed Kaye, M.D., Chief Medical Officer More...
• FibroGen, Inc. Appoints R. Wayne Frost, Pharm.D., J.D., Vice President of Regulatory Affairs More...
• Grifols Announces the Appointment of Thomas Glanzmann as Chairman of its New Board of Directors for U.S. Operations More...
• Dr. David Kaplan Joins Kraig Biocraft Laboratories, Inc. Scientific Advisory Board More...
• Tikcro Technologies Reports 2011 First Quarter Results More...
• Johnson & Johnson (JNJ) Unit Ortho-McNeil-Janssen Pharmaceuticals, Inc. Ordered to Pay Record Breaking $327 Million Over Deceptive Risperdal Marketing Claims More...
• Tekmira Pharmaceuticals Corporation Files Amended Complaint in Alnylam Pharmaceuticals (ALNY) Litigation More...
• InfoMedics, Inc. Expands in Europe, Latin America and Asia-Pacific More...
• Roche (RHHBY) Melanoma Drug Cuts Risk Of Death By 63 Percent; Bests Bristol-Myers Squibb Company (BMY) In Study More...
• Pfizer Inc. (PFE)'s Aromasin Blocks Breast Cancer in Healthy, At-Risk Women in Study More...
• Ariad Pharmaceuticals, Inc. (ARIA) and Merck & Co., Inc. (MRK)'s Cancer Drug for Bones-Tissue Extends Patient Lives in Study More...
• Pfizer Inc. (PFE) Lung Cancer Pill May Double Survival More...
• United Therapeutics Corporation (UTHR)'s FREEDOM-M Phase 3 Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint More...
• American Regent, Inc. Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates More...
• Incyte Corporation (INCY) Submits New Drug Application for Ruxolitinib in Myelofibrosis to the US FDA More...
• Finally, a Pill for Men 'With No Side-Effects' Which Could be on the Shelves in a Few Years Columbia University Study More...
• New Generation Asthma Drug Could Improve Metabolism, Garvan Institute of Medical Research Research Suggests More...
• Epilepsy Drugs' Risk of Birth Defects May Be Dose-Dependent, Karolinska Institute Study More...
• Chiasma Inc.'s Octreolin(TM) (Oral Octreotide) Shown to Inhibit Growth Hormone in Healthy Subjects More...
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| Daily Digest Stockinvestips |
Upgrades for June 6, 2011 Monday:
1) American Eagle ( NYSE: AEO) upgraded from sell to hold by Brean Murray.
2) City Holding Co ( NASDAQ :CHCO ) upgraded from hold to buy by Standpoint Research.
3) Digital Globe ( NYSE: DGI) upgraded from Mkt Perform to Outperform by Morgan Keegan .
4) First Financial ( NASDAQ: FFBC) upgraded from neutral to outperform by Robert W. Baird.
5) Gap ( NYSE: GPS) upgraded from hold to buy by Standpoint Research.
6) MakeMyTrip ( NASDAQ: MMYT ) upgraded from perform to outperform by Oppenheimer.
7) New Oriental Education & Technology ( NYSE : EDU ) upgraded from neutral to outperform by Robert W. Baird.
8) Olympic Steel ( NASDAQ: ZEUS) upgraded from neutral to buy by Davenport.
9) Weyerhaeuser ( NYSE: WY ) upgraded from underperform to neutral by DA Davidson.
10) Xueda Education ( NYSE : XUE ) upgraded from neutral to outperform by Robert W. Baird.
See More
Downgrades for June 6, 2011 Monday:
1) Lorillard ( NYSE : LO) downgraded from buy to neutral by Davenport.
2) Scotts Miracle-Gro ( NYSE : SMG ) downgraded from buy to neutral by Longbow.
See More
Coverage Initiated for June 6, 2011 Monday:
1) Capstone Turbine ( NASDAQ : CPST ) coverage initiated with outperform by FBR Capital.
See More here at stockinvestips
Tech Five: Technology Headlines for June 6, 2011 ( Monday ) !!
1. Sony, for once, isn't in the hacking news this morning: Instead game making rival Nintendo is now reporting a serious attack on its servers. The company claims no sensitive information leaked out, but it is the very first time such a large-scale assault has targeted Nintendo--although LulzSec's attack was aimed at exposing similarly big security holes as those which enabled precious user data to be stolen from Sony's servers.
2. Meanwhile in happier Nintendo news, we're learning about its next-gen Wii successor. A publication that was previously accurate in predicting the DSi and 3DS has said the Wii games console will have a controller with integrated six-inch touchscreens to tap into the tablet OC vibe, that each controller will be playable as its own portable console, will sport a camera, and will arrive late 2012.
3. The battle between Google and China is getting weird: Last week Google blamed Chinese sources for a sophisticated cyberattack, using phishing techniques aimed at government officials and Chinese political campaigners. Now a Chinese paper, the People's Daily (paper of the ruling Communist party) is warning Google that it's become a "political tool" and its business will be made to suffer when the "winds shift direction."
4. The Kno tablet was highly praised when its prototype hit the scene last year, aimed squarely at students with a textbook and lecture-centric interface. But the iPad phenomenon changed the scene so much that Kno abandoned its hardware plans. The firm since reinvented its business model as an iPad app, which launched this past weekend promising reduced prices on tens of thousands of educational textbooks and other bonuses. Will the new plan succeed?
5. AT&T's Ralph de la Vega has revealed that his firm is collaborating in the design of a next-gen, even smaller SIM card for mobile phones--prompting speculation that he's referencing the plans of that famous Cupertino-based PC and smartphone maker. A smaller card for smaller phone designs is a "no-brainer," he said, while also mentioning that Windows 7 phones weren't selling as well as either AT&T or Microsoft would have hoped.
( Source: Fast Company )
( Source: Fast Company )
Biotech Mover: Rxi Pharmaceuticals ( NASDAQ: RXII ) announced positive Phase II efficacy results of NeuVax (E75) , Stock jumped 15 % to $1.56.
Below is the News Release:
RXi Pharmaceuticals Announces Positive NeuVaxTM (E75) Phase 2 Efficacy Results After 36 Months of Follow-Up
NeuVax (E75) demonstrates statistical significance in 3-year Disease Free Survival (DFS) in adjuvant breast cancer, with 0% recurrence in the treated group versus 22.2% in the untreated group
NeuVax continues to demonstrate an excellent safety and tolerability profile
Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study expected to initiate in 1H 2012 under FDA approved Special Protocol Assessment (SPA)
WORCESTER, Mass.--(BUSINESS WIRE)--RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer.
“We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
The NeuVax Phase 2 trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS), the same endpoint in the FDA approved SPA (Special Protocol Assessment) for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study.
“These encouraging clinical results underscore the potential for cancer immunotherapy to develop into potent and well tolerated targeted therapies,” stated Dr. Beth Mittendorf, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who was also named the primary investigator for the Phase 3 trial. “The results of this trial suggest that NeuVax addresses an unmet medical need and clearly warrants a randomized, multicenter Phase 3 study to confirm efficacy and safety in a larger population.”
Key highlights from the Phase 2 trial include:
Statistically significant increase in disease free survival (DFS) at 36 months in the NeuVax treated group vs the control group for the planned Phase 3 patient population (p=0.035). The vaccine treated group showed no recurrences of cancer (0% recurrence rate), while the control group demonstrated a 22% recurrence rate which is consistent with historical norms. The planned Phase 3 patient population as defined in the FDA approved Special Protocol Assessment (SPA) includes breast cancer patients who are node positive, have low to intermediate HER2 expression (HER2 1+ and 2+ by IHC), are HLA A2+ & A3+ and who are disease free following standard of care therapy.
An excellent safety profile, with no serious adverse events (SAE’s) related to drug reported to date. All adverse events (AE’s) reported were minor and resolved within 24 hours.
In the ITT (intent to treat) population who received all ranges of doses and schedules, the low to intermediate HER2 expressers continued to show significant activity in improvement of DFS (p=0.045), with the vaccine group demonstrating a reduction of 66% in relative risk for recurrence. This data demonstrates strong support for targeting of low to intermediate HER2 expressers, a group for which there is currently no HER2 directed therapies.
The optimally dosed (1 milligram of E75 plus 250 micrograms of GM-CSF) group continues to demonstrate superior efficacy compared to sub-optimal doses (varying doses from 100 - 500 micrograms E75 plus 125 – 500 micrograms GM-CSF), with a recurrence rate of 3% for the optimally dosed group vs 12% for the sub-optimally dosed group and 14% for the control group.
“These promising results strongly build upon and support previously reported efficacy and safety data,” commented Dr. Mark Ahn, CEO and president of RXi. “We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
About NeuVax™ (E75)
NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase II trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for a Phase 3 clinical trial in adjuvant therapy of women with low-to-intermediate HER2+ status.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for Human Epidermal growth factor Receptor 2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease are eligible for Herceptin® (trastuzumab; Roche-Genentech) which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2 positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2 targeted adjuvant treatment options to maintain their disease free status.
About RXI-109
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a self-delivering RNAi compound (sd-rxRNA) for the reduction of dermal scarring in planned surgeries. RXI-109 is designed to reduce the expression of CTGF (connective tissue growth factor), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. RXi is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. Pending FDA review, the company intends to use an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. For more information, visit www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the future expectations, plans and prospects of the development of RXi Pharmaceuticals Corporation's products. These forward-looking statements about future expectations, plans and prospects of the development of the Company's products are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in the Company's most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
Did the Swedish king visit strip clubs, and why did his friend seek a gangster's help to snuff out the scandal? Those questions have the nation in a tizzy and are posing the monarchy its most serious challenge during Carl XVI Gustaf's nearly four decades on the throne.
The media, much less enthralled by the royal family than the public, is attacking the 65-year-old monarch with unprecedented fury.
One leading newspaper has even urged the king to step down. Others suggest he should go if it turns out he was lying when he denied visiting strip clubs in the U.S. and Slovakia, claims first presented in a book published last year.
"His reputation has of course been hurt by this and he's had a difficult time defending himself," said royal commentator and writer Roger Lundgren. "But this has certainly taken on proportions that are approaching the grotesque."
At the heart of the scandal is "The Reluctant Monarch," a book released in November that for the first time put into print long-standing rumors about the private life of Carl Gustaf, who has three adult children with his German-born wife, Queen Silvia.
The book alleged that the king had a secret love affair in the 1990s and described how he and his friends frequented private night clubs in Stockholm where they were entertained by scantily clad women. It also claimed he visited exclusive strip clubs during foreign visits — in Atlanta during the 1996 Olympics and in Slovakia in 2008 — citing former employees of those establishments.
Many of the allegations are poorly sourced and critics say the book, which was presented as a biography, amounts to nothing more than a gossip magazine in hard cover.
The king's supporters say he's the victim of a malicious slander campaign fueled by republican forces who normally don't get much attention in Sweden.
Most Swedes want to preserve the constitutional monarchy even though it's widely seen as contradicting the principles of democracy and equality that underpin Swedish society. The monarchy's survival hinges to a large degree on its popularity.
"The Swedish royal court, like the Danish and Norwegian, depends on widespread trust from the public," political editor Peter Wolodarski wrote in the Stockholm daily, Dagens Nyheter. "The day people start to doubt whether the top representatives of the royal court are telling the truth, they (the royals) live dangerously."
A recent poll showed about 44 percent of the Swedes wanted Carl Gustaf to remain king, while 17 percent said he ought to give way to his eldest daughter, the popular 33-year-old Crown Princess Victoria.
Research institute TNS-Sifo interviewed 1,000 people for the May 25-26 poll. The margin of error was 2 to 3 percentage points.
A similar poll around 12 months ago, showed 64 percent of Swedes wanting the king to stay on the throne.
Carl Gustaf first addressed the allegations in a somewhat confused monologue to reporters at his annual moose hunt in November, saying his family was "turning the page." He didn't deny the allegations, which was seen by many as a partial admission.
It might have been expected to end there. After all, the king was not accused of anything illegal and Swedes don't get into a moral panic about extramarital affairs. But the question of strip club visits — frowned upon in Sweden's egalitarian society — would not go away.
And suggestions the king may have spent hefty sums on such visits raised questions about whether the public should be provided more information about how the royal court uses its annual 122 million kronor (nearly $20 million) taxpayer-funded stipend.
In May, the story took a new twist when Swedish Radio aired a secret recording in which one of the king's friends, Anders Lettstrom, was heard discussing the scandal with a reputed gangland figure. Their conversation centered on Mille Markovic, a former night club owner and a key source in the book who claims to have pictures of the king's entourage in compromising situations.
Swedish Radio broadcast parts of a conversation where Lettstrom wanted to know exactly what material Markovic had and how much it would cost to make him hand it over.
After initial denials, Lettstrom issued a statement to Swedish news agency TT admitting he had contacted criminals in a misguided attempt to find out "how so many lies about me and others" could have been spread in the book about the king. Lettstrom said he had acted alone and that the king knew nothing about it.
Under mounting media pressure, the king agreed to an interview with TT about his private life on Monday. In the interview, Carl Gustaf rejected any knowledge of Lettstrom's contacts with criminals and said he no longer considered Lettstrom a friend. He also denied having visited the specific strip clubs mentioned in the book.
In answer to whether he had ever visited a strip club, the king asked the reporter to define what exactly he meant by one, then recalled a visit to a cabaret in Paris.
The interview didn't go down well with the public or the media.
Tabloid Aftonbladet, one of Sweden's biggest newspapers, called on the king to abdicate, saying his credibility had been tainted.
"If it turns out that the king lied straight into (Swedes') faces, we could be one step closer to a republic," another newspaper, Goteborgs-Posten, said in an editorial.
The TT reporter also asked the king whether the situation had made the monarch think about passing the crown to Victoria.
"I think that's hard to understand, that question. It's not relevant," the king said. "By tradition and custom, that's not how it works."
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
An Indian defense ministry official says the country's cabinet has approved a proposal to buy 10 American C-17 military aircraft for more than $4 billion, the largest defense deal between the two nations.
The official, who could not be named because he wasn't authorized to discuss the subject, said the deal requires the aircraft maker, Boeing Co., to invest 30 percent of the $4 billion in defense-related industries in India.
The news comes after Boeing and another American defense manufacturer, Lockheed Martin, were rejected for a multibillion-dollar contract to supply fighter jets to the Indian air force.
India is expected to spend $80 billion over the next decade to upgrade its military.
The agreement still must be signed by both countries.
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Apple Chief Executive Steve Jobs returns on Monday to the stage at San Francisco's Moscone center to take the wraps off what investors hope will be the next source of growth for the world's most valuable technology company.
Jobs, who has been on medical leave for months and last took the stage in March to present the iPad 2, will unveil the iCloud, a Web-based service that lets consumers stream music they bought to any Apple device, pitting it against rivals Google and Amazon.com.
That expansion into cloud computing is seen as crucial if the company is to stay competitive with increasingly popular open-sourced software, such as Google's Android operating system, according to analysts and investors.
The iCloud has the potential to make Apple's iTunes even more powerful, making it tougher for rivals to keep up, Sterne Agee analyst Shaw Wu said.
"It looks like Apple will likely offer some base service for free," Wu said. "Competitors, including RIM, Google, Amazon and Microsoft already have a hard time competing with iTunes as it is, but we believe will likely find it even tougher with iCloud enhancements."
The Moscone center in San Francisco — ground zero in the launch of several iconic Apple gadgets such as the iPad — was a hive of activity this week as workers put the finishing touches on banners featuring a giant Apple logo.
Apple has been busy wrapping up negotiations with major record labels to secure licenses for its iCloud service, which is also expected to include a revamped version of its little-known MobileMe storage service.
The licenses will help Apple introduce scan-and-match technology that scans a user's hard drive and provides access to music found there from the company's own servers.
Currently, Google and Amazon require users to upload their library of songs.
Some analysts say the iCloud has the potential to be a new model for media consumption, which could also spark more demand for Apple devices.
It could also enable the consumer giant to design new devices around the service, said Trip Chowdhry, managing director of Global Equities Research.
"iCloud by itself will not be a billion dollar revenue opportunity," Chowdhry said. "It is an enabling technology ... once you have things in the cloud, you can create new devices that (have not) been created right now."
The company, legendary for keeping its agenda under wraps, has been unusually open about what it plans to show at its annual developers' conference, a five-day extravaganza for developers that begins on Monday.
Apart from iCloud, Jobs will introduce software upgrades at the conference, including Lion, its Mac OS X computer operating system and the next version of its mobile operating system.
Still, fans, developers and Wall Street cannot help but feel the consummate showman may have a surprise or two up his sleeve because he typically takes the stage only for major events.
There "certainly could be" a surprise, said Current Analysis analyst Avi Greengart, who often attends Apple events. "Apple is known for just one more thing."
Apple has used the WWDC venue in the past to unveil a new iPhone, but some sources told Reuters they did not expect the new model to appear until September.
But any appearance by Jobs, who survived a rare form of pancreatic cancer, is usually closely scrutinized by Wall Street, given that the fortunes of the $320 billion company are so closely linked with the co-founder.
"One of the things that's going to be interesting to see is how much actual introduction Steve does and how much he is playing emcee," Greengart said.
"He may just come out on stage three times — once to introduce the things, once to punctuate and once to close. Or he may be on stage for two-and-a-half hours," he added.
( Source: Reuters )
Genta Incorporated ( OTC: GNTA ), penny stock moving higher 28 % today and stock up more than 61 % since last 3 trading sessions. Company has announced an updated results of its Phase II clinical trials of Tesetaxel. Investors seeing a hope in the positive results of trials. Traders might keep an eye on the stock before it explode.
Below is the detailed news release from Genta Incorporated
Genta Presents Updated Results of Phase 2 Trial of Tesetaxel in Patients With Advanced Gastric Cancer
Weight-Based Dose Established for Global Clinical Studies
 |
| Genta Inc |
BERKELEY HEIGHTS, N.J., June 3, 2011 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) today announced updated interim results from a trial of tesetaxel used as 2nd-line treatment in patients with advanced gastric cancer. The ongoing trial is lead by the M.D. Anderson Cancer Center in Houston, TX. The data are presented in conjunction with the 2011 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. Tesetaxel is the leading oral taxane in clinical development.
The trial is evaluating 3 cohorts of patients, all of whom had failed one prior chemotherapy regimen that must have included a platinum-containing compound (cisplatin, oxaliplatin, or carboplatin) and a fluoropyrimidine compound (5-fluorouracil [5-FU] or capecitabine [Xeloda®; Hofmann LaRoche, Inc.]). Two patient cohorts were treated over a range of "fixed" (as opposed to "weight-based") doses starting at 40-45 mg (Cohort 1) and 50-60 mg (Cohort 2), whereas Cohort 3 is using conventional weight-based dosing at the previously identified maximally tolerable dose (MTD).
In Cohorts 1 and 2, wide variations in body weight were observed. By example, body surface area (BSA, a composite measure of weight and height), of an average U.S. adult male approximates 1.7 m2, whereas the median BSA for patients in the first 2 study cohorts was 1.9 and 2.0 m2, respectively. One major response was observed in each of 11 and 13 patients in the first 2 cohorts, respectively; however, no episodes of > Grade 3 neutropenia were observed in either fixed-dose cohort, suggesting that patients had been substantially under-dosed. Accordingly, Cohort 3 – which is currently open to accrual – employs a starting dose of 27 mg/m2 with escalation to 35 mg/m2 as tolerated in subsequent cycles. Data from this cohort are too early to evaluate.
Since overall survival (OS) is the primary endpoint in planned Phase 3 studies, an analysis of OS was conducted across all 3 cohorts in which any patient's actual starting dose converted to a weight-based dose of > 26 mg/m2. With early followup, median OS in this group of 12 patients has not been reached, but currently exceeds a median of 7.5+ months. For context, docetaxel (Taxotere®; Sanofi, Inc.), a standard taxane, is approved for 1st-line treatment of gastric cancer. Four publications have reported the use of docetaxel as 2nd-line therapy in gastric cancer that show response rates ranging from 5% to 19% and median OS ranging from 3.5 to 8.4 months.
"While fixed dosing is convenient, the extremes of body weight observed in Western subjects has lead to substantial under-dosing, which in a global study would greatly increase the risk of under-treatment in seriously ill patients," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We now have a broadening experience in 1st and 2nd-line gastric cancer in both Western and Asian patients, both alone and in combination with other agents. Consequently, we have high confidence that safe and potentially effective dosing schedules of tesetaxel have been identified for these disparate populations."
Tesetaxel in Advanced Gastric Cancer
In a completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 patients had also received a 3rd chemotherapy drug. Results showed 7 major objective responses (5 confirmed and 2 unconfirmed) in 35 evaluable patients, with 14 patients having achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Unlike standard taxanes that must be administered intravenously, tesetaxel is a capsule that is taken by mouth. Compared with the standard agents, clinical and preclinical data show that tesetaxel:
Is active in diseases that are resistant to standard taxanes
Is not associated with serious (occasionally fatal) hypersensitivity reactions
Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
Reduces damage to peripheral nerves
Offers flexible and convenient dosing for patients
Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
About Gastric Cancer
Cancer of the stomach (gastric cancer) is the second most common cause of death worldwide due to cancer. The disease is the fourth most common type of cancer, and approximately one million new cases of gastric cancer are diagnosed each year. The illness shows a marked geographic distribution, with most cases arising in East Asia. The disease is especially prevalent in Korea, Japan, and China. The American Cancer Society estimates that approximately 21,000 new cases of gastric cancer will be diagnosed in the U.S. during 2010, resulting in approximately 11,000 deaths.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company is developing tesetaxel, a novel, orally absorbed taxane that is in the same class of drugs as paclitaxel and docetaxel. As the leading oral taxane in clinical development, tesetaxel has been evaluated in a broad program of completed or ongoing Phase 2a/Phase 2b clinical trials. The Company has announced that gastric (stomach) cancer will be the lead indication for Phase 3 registration studies. A second portfolio compound, Genasense® (oblimersen sodium) Injection, is a modified DNA-based antisense drug that may enhance the effectiveness of anticancer therapy. The Company has recently announced that a randomized trial of Genasense did not increase overall survival in patients with advanced melanoma. Genta is exclusively marketing Ganite® (gallium nitrate injection) in the U.S, which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially," "anticipate," "could," "calls for," and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
the Company's ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
the safety and efficacy of the Company's products or product candidates;
the timing of commencement and completion of any clinical trials;
the Company's assessment of its clinical trials;
the Company's ability to develop, manufacture, license, or sell its products or product candidates;
the Company's ability to enter into and successfully execute any license and collaborative agreements;
the adequacy of the Company's capital resources and cash flow projections, the Company's ability to obtain sufficient financing to maintain the Company's planned operations, or the risk of bankruptcy;
the adequacy of the Company's patents and proprietary rights;
the impact of litigation that has been brought against the Company; and
the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2011 and its most recent quarterly report on Form 10-Q.
Penny Stock exploded : Broadcast Mrktg New ( PINK : BDCM ) up more than 420% without any specific news or announcements. Volumes are much above than average but its not significant enough as stock price is just 37 cents.
There is not enough response form penny stock traders as volumes haven't reached a million share trade. Cautious call for trade.
Our Call: Stay away, Don't initiate any positions.
There is not enough response form penny stock traders as volumes haven't reached a million share trade. Cautious call for trade.
Our Call: Stay away, Don't initiate any positions.
Ada-Es, Inc ( NASDAQ: ADES ), stock move up 65 % to $ 16.53 as company announced stake sale in Clean Coal Solutions LLC. The Deal was about 60 million of equity sale.
Our Call : Small buy positions for either trading or investment purpose may be initiated.
Below is the detail news:
ADA-ES Announces $60 Million Equity Sale in Clean Coal Solutions, LLC Joint Venture to an Affiliate of Goldman Sachs
Investor Will Receive An Effective 15% of the Joint Venture
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| ADA-ES Inc |
ADA-ES, Inc. (NASDAQ:ADES) (“ADA”) today announced the sale of a 15.8% equity interest in Clean Coal Solutions, LLC (“Clean Coal”), ADA’s 50:50 joint venture with an affiliate of NexGen Resources Corporation (“NexGen”), by ADA and NexGen for $60 million to GSFS Investments I Corp. (“GSFS”), an affiliate of The Goldman Sachs Group, Inc. (“Goldman Sachs”). Closing of the transaction was simultaneous with signing.
GSFS’s 15.8% equity interest in Clean Coal is represented by Class B Units, which are non-voting except as to approval rights on certain matters. The Class B Units entitle the holder to a targeted return of at least 15%. ADA and NexGen each received gross proceeds of $30 million at closing and ADA will receive an additional $1.8 million payment from NexGen to maintain NexGen’s interest in Clean Coal. Given the 2.5% direct interest both ADA and NexGen retain in the individual entities previously formed to lease the “Refined Coal” facilities, the effective sharing ratio of net cash generated by all expected Refined Coal operations is 15% to GSFS and 85% to ADA and NexGen.
Clean Coal’s patented coal technology, CyClean, is a cost effective coal technology to produce Refined Coal, which reduces emissions of NOx and mercury. The American Jobs Creation Act of 2004 included changes to Section 45 of the Internal Revenue Code that incentivize the production of Refined Coal through an annually escalating tax credit, which is presently $6.33 per ton.
In conjunction with the equity purchase, Clean Coal granted Goldman Sachs the exclusive right to lease Refined Coal facilities targeted to produce up to 12 million tons of Refined Coal per year on terms that will be economically more favorable to Clean Coal than those in effect for the leases that Clean Coal entered into with another affiliate of Goldman Sachs in June 2010.
Dr. Michael D. Durham, President and CEO of ADA, commented, “We are very pleased to welcome this additional investment by Goldman Sachs. We believe that their continued financial interest in Clean Coal further validates the environmental and financial benefits of this proven emissions control technology. As we continue to assess ADA's liabilities resulting from the arbitration panel's recent interim award to Norit Americas, Inc. and related indemnity obligations, this cash infusion enhances our balance sheet and our ability to fulfill those obligations."
Additional information regarding the transaction is available in ADA’s Current Report on Form 8-K, which ADA filed with the United States Securities and Exchange Commission on June 3, 2011.
About ADA-ES
ADA-ES is a leader in clean coal technology and the associated specialty chemicals, serving the coal-fueled power plant industry. Our proprietary environmental technologies and specialty chemicals enable power plants to enhance existing air pollution control equipment, minimize mercury, CO2 and other emissions, maximize capacity, and improve operating efficiencies, to meet the challenges of existing and pending emission control regulations.
With respect to mercury emissions:
We supply activated carbon (“AC”) injection systems, mercury measurement instrumentation, and related services.
We are also a joint venture participant in ADA Carbon Solutions (“ADA-CS”), which has commenced operations at its AC production facility
Under an exclusive development and licensing agreement with Arch Coal, we are developing and commercializing an enhanced Powder River Basin (“PRB”) coal with reduced emissions of mercury and other metals.
Through our consolidated subsidiary, Clean Coal Solutions, LLC (“Clean Coal”), we provide our patented Refined Coal technology, CyClean, to enhance combustion of and reduce emissions from burning PRB coals in cyclone boilers.
In addition, we are developing CO2 emissions technologies under projects funded by the U.S. Department of Energy (“DOE”) and industry participants.
( Source : Business Wire )
