Posts Tagged var-page

Alexza rockets on re-submission of Adasuve NDA – Pharmaceutical …

Monday, June 25th, 2012 | Permalink

Alexza has stated that it believed the deficiencies were medical device specific and readily addressable. Since the receipt of the CRL, Alexza has received further clarification of the specific deficiencies from the FDA and has …

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Alexza rockets on re-submission of Adasuve NDA – Pharmaceutical …

Severe sepsis causes almost 10% of cancer deaths; $CTSO

Wednesday, January 18th, 2012 | Permalink

In 2004, Dr. Mark Williams and his colleagues from Eli Lilly & Co. in Indianapolis, and Health Process Management, LLC, Pennsylvania analyzed hospitalizations from 1999 across six US states and discovered that ”severe sepsis is a common, deadly, and costly complication in cancer patients. This complication was associated with nearly a three-fold increase in the time spent in hospital. We estimate that the annual hospital costs for these patients exceed US $3 billion annually.” They discovered that “almost 5% of the cancer patients that were hospitalized in the six states were found to have severe sepsis. When extrapolated to the rest of the USA, this corresponds to around 126,000 cases every year.” Hospitalized cancer patients with severe sepsis were more than five times more likely to die than cancer patients who were not severely septic. 37.8% of patients with cancer and severe sepsis died in the hospital in comparison to just 7.2% of cancer patients without severe sepsis. This corresponds to the death of around 46,700 patients every year. ”Our study demonstrates the devastating complication of severe infections in cancer patients. Improvement in infection control, such as early appropriate antibiotics, in this population could have a significant impact on overall cancer survival,” said Williams. Read the full article on Science Blog and the study on Critical Care .  In addition to using antibiotics and other supportive care measures, another promising approach to fight sepsis is the reduction of “cytokine storm” and the removal of other toxic substances from the blood that can cause multiple organ failure – the leading cause of death in the ICU from sepsis and other critical care illnesses. CytoSorbents Corporation (OTCBB: CTSO) , a critical care-focused therapeutic device company, is working on this type of blood purification technology. The company’s flagship product, CytoSorb, is an extracorporeal cytokine filter that uses biocompatible, highly porous polymer beads to actively remove toxic substances from blood and other bodily fluids. It recently achieved European regulatory approval and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in cases where cytokines are elevated. Read more about CytoSorbents and its blood purification technology . 

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Severe sepsis causes almost 10% of cancer deaths; $CTSO

Coronado Biosciences (NASDAQ: CNDO) Debuts on Nasdaq, Moves Two Lead Drugs Forward

Tuesday, December 20th, 2011 | Permalink

Coronado Biosciences (NASDAQ: CNDO) is a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of inflammatory diseases and cancer. On December 15, Coronado received NASDAQ approval for listing. The stock opens today at $6.50. However, CNDO has chosen an unusual path to becoming a publicly listed company. The company raised $47.4 million privately over the last year, then filed a Form 10 with the SEC “so it could become a public company by registering all its private shares as common stock, rather than undergoing a typical, underwritten IPO. Coronado—which moved from New York City to Burlington, MA, in August—was approved to trade over the counter in mid-November.” As former biotech editor of BusinessWeek and current editor of Xconomy New York   Arlene Weintraub  writes, “By choosing to go it alone, without an underwriter, Coronado has shouldered the entire onus of attracting investors. CEO Bobby Sandage says he’s been making the rounds at investment conferences, and working hard to meet Nasdaq’s minimum requirements for publicly listed companies. “We need a certain number of shareholders, and with 550 we’re well above the requirement,” he says. “We needed a minimum bid price of $4 and for the stock to be trading every day. We got our volume up to the 10,000-to-20,000 range.” It also helped that on November 22, an analyst for Roth Capital Partners began covering Coronado in a report declaring the company to be “the caviar of biotech.” In another article about Coronado , written over the summer, Weintraub wrote that “Management’s deliberate decision not to seek out Big Pharma partners to bankroll its clinical trials may seem bold at a time when cash-strapped biotechs need all the help they can get. But Sandage and his team of seven are confident that their two experimental treatments—CNDO-201 [to treat the intestinal disorder Crohn’s disease] and an anti-cancer molecule called CNDO-109—are so promising that they can afford to handle the research themselves, so they can ultimately hold onto all the profits. “They have such broad applications for huge unmet medical needs,” Sandage says, adding that Coronado keeps costs down by outsourcing R&D.” It looks like that confidence is well founded. Both CNDO-201 and CNDO-109 are sparking interest among investors. CNDO is currently preparing to begin Phase 1 studies of CNDO-201, a drug containing 2,500 eggs from a parasite found in pigs. If all goes well, Sandage says, another trial will begin in the second quarter of 2012. The company also presented data from a Phase 1 study of CNDO-109 last week at the annual meeting of the American Society of Hematology in San Diego. The data showed that the drug lengthened remission rates. A second trial is planned for this drug as well, also in early 2012.  As for the company’s stock, Weintraub writes that: “After an early trade at $11 when Coronado was on the OTC bulletin board, shares have fallen back to the $6 range. Because Coronado went public via a Form 10, there was no set offering price—the price will be determined entirely by the market. Sandage isn’t concerned.  “Now there are many more broker-dealers who can trade the stock,” he says. As for Coronado’s speedy route from the OTC market to a true Nasdaq listing, Sandage hopes it sends a positive signal to antsy biotech investors: “I think Nasdaq saw that Coronado was a real company.” Real the full article on Xconomy.com . 

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Coronado Biosciences (NASDAQ: CNDO) Debuts on Nasdaq, Moves Two Lead Drugs Forward

For AEterna Zentaris And Keryx (NASDAQ: KERX), Phase 3 Set For Success; Takeover Likely

Monday, December 19th, 2011 | Permalink

Keryx Biopharmaceuticals (NASDAQ: KERX) is an emerging small-cap biopharma company that has a pair of lead compounds in late-stage, Phase 3 development for the treatment of cancer (perifosine) and renal disease (Zerenex), under Special Protocol Assessment (SPA) agreements with the FDA. KERX is Aeterna Zentaris ’ partner and licensee for perifosine in the USA, Canada and Mexico. On Tuesday, Seeking Alpha contributor Jeremy Richards of Private Wealth Fund wrote: “Without question, our company believes strongly in AEterna Zentaris’ (AEZS) lead drug candidate and the likelihood of a takeover of the company.” Richards summarized some of his previous points and provided additional, new analysis of the clinical data to support his position. About Perifosine Richards wrote: “The P3 Perifosine, in combination with Xeloda (Capecitabine) X-Pect study of Keryx, is a trial for a drug combination used to treat metastatic colorectal cancer (mCRC). The combination is referred to as PCAP for Perifosine-Capacitabine. This is a very important study because the number of deaths occurring each year as estimated by WHO is 610,000 worldwide, including 142,570 new cases and 51,370 deaths in the U.S. in 2010. The death rate from mCRC is about 17 per 100,000 people annually in the U.S. CRC is the second most common cancer after lung cancer and more lives are lost each year to colorectal cancer than to breast cancer and AIDS combined. More than 60% of cancers are detected in their late stages. Preliminary evidence is that PCAP is the most effective drug combination known for mCRC.” Read the full article on Seeking Alpha.

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For AEterna Zentaris And Keryx (NASDAQ: KERX), Phase 3 Set For Success; Takeover Likely