| This week's sponsor is AMRI. |  | | |
Today's Top Stories
1. Jennerex cheered by early efficacy data for cancer-killing virus
2. Roche CEO Schwan believes diagnostics will be key to success
3. Cash-strapped Oxigene lays off staffers, shelves PhIII study
4. Beleaguered Xoma CEO Engle turns in his walking papers
5. Delcath shares slump after chemo system fails to deliver in PhII cohort Also Noted: Novella
Spotlight On... ReNeuron cleared to proceed with groundbreaking stem cell study
Pfizer extends offer for Icagen; Maryland readies new biotech funds; and much more... More Fierce Life Sciences News:
1. Merck taps Zymeworks' high-tech antibody shop in $187M deal
2. Infant rotavirus shots may benefit the unvaccinated
3. Promega adding molecular-biology capacity with new plant
| Sponsor: Okta FierceLive! Webinars > Webinar: Active Directory & the Cloud for Biotech & Pharma Sept. 21, 2pm ET / 11am PT
> Inside the mHealth Revolution with Welch Allyn: Realizing the Potential of Connected Devices, September 22, 11am ET / 8am PT
Events > Roche Colorado Peptide Symposium - September 12 -14 - Boulder ,CO
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA
> 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011
> 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK
> LES Meeting: Network with Top Licensing & Business Development Execs! - October 16-19 - San Diego, CA
> BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA
> Canadian Annual Meeting 2011: New Models - New Frameworks - New Partnerships - November 1-2, 2011 - Ottawa Ontario, Canada
Marketplace > Capitalizing on the Outsourcing Option - New Fierce eBook
> Free White Paper: The FDA Review Process: a Technical Look
Jobs > Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics
> Need a job? Need to hire? Visit FierceBiotech Jobs
* Post a classified ad: Click here.
* General ad info: Click here | Today's Top News 1. Jennerex cheered by early efficacy data for cancer-killing virus
A small, mid-stage study of Jennerex's genetically engineered virus offered some important preliminary proof-of-concept data on its ability to zero in on cancer cells with just a single infusion. Reporting in Nature, investigators said biopsies confirmed the virus was replicating inside the tumors of 7 of the 8 people with metastatic cancers who were given the engineered dose, leaving healthy tissue untouched. Researchers noted several weeks after treatment the tumors in half of the group had stopped growing, indicating their cancers may have stabilized, and that in one case tumors appeared to shrink. San Francisco-based Jennerex turned to the vaccinia virus for its raw material. Investigators then armed the virus, which is known to stealthily slip past the immune system, with a protein that launches an immune system attack on cancer cells, according to an article in MIT Technology Review. A second marker gene was used to track replication in samples. "Our platform technology opens up the possibility of selectively expressing multiple transgene products with complementary mechanisms of action at high concentration in tumors systemically," says Jennerex CEO David Kirn. "This is a first in medical history. We believe it will take truly innovative, multi-mechanistic approaches to significantly prolong survival, and to potentially cure patients with metastatic solid tumors. JX-594, with its ability to reach tumors systemically after IV infusion, coupled with its three complementary mechanisms of action, represents a bold new approach to the treatment of metastatic cancers." With such a small patient population, Jennerex is still a long way away from offering convincing efficacy data. But the early positive indications will help fuel a hot field in the cancer drug discovery side of the biotech business. If cancer-killing viruses continue to build up promising efficacy data, it will help attract a group of Big Pharma companies interested in capitalizing on a new generation of oncology drugs. For Jennerex, which raised $8.6 million just days ago, the news sets the stage for a Phase IIb clinical trial of JX-594 that starts later in the year involving liver cancer patients who have failed to respond to Nexavar. Researchers have a number of big hurdles to overcome, including finding out whether the human body will adjust quickly to these viral approaches, potentially eliminating their effectiveness. - here's the Jennerex release
- get the story from MIT Technology Review
- check out the report from Reuters Related Article:
Transgene teams with Jennerex in $116M cancer pact Read more about: Jennerex, JX-594
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 | Webinar: Active Directory & the Cloud for Biotech & Pharma
Sept. 21, 2pm ET / 11am PT
Biotech and pharmaceutical companies are leaders cloud/SaaS technology adoption. This webinar will discuss the pros and cons of extending Active Directory to Cloud/SaaS Apps for single sign-on and automated provisioning/de-provisioning. Register today. |
2. Roche CEO Schwan believes diagnostics will be key to success
With half of Roche's late-stage drugs already dependent on diagnostic tests to identify a specific group of patients most likely to respond, it's no wonder that CEO Severin Schwan (photo) believes the day is coming when the majority of the Big Pharma company's portfolio will consist of carefully targeted therapeutics. "In 10 years we would see half of our portfolio to be targeted therapies. And if anything, I would assume in 20 years this percentage is going to increase," Schwan told Reuters. The CEO added the revolution in molecular biology that's under way is just as important as the time when physicians first started to open up patients to see what was ailing them. Schwan is in some ways the ideal champion for the growing use of diagnostics in medicine and drug development. He headed Roche's big diagnostics division before taking the helm, and he sees the company's direct involvement in the field as a major advantage. "We believe that by having it integrated at a very, very early stage, we have a competitive edge," said Schwan. - here's the story from Reuters Related Articles:
Niche cancer drugs highlight the targeting trend in R&D
Pfizer (finally) wins a big one with crizotinib approval for lung cancer
Roche CEO Schwan spotlights Roche's top three blockbuster hopefuls Read more about: Roche, personalized medicine, Severin Schwan, diagnostics
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3. Cash-strapped Oxigene lays off staffers, shelves PhIII study
The once high-flying Oxigene says it doesn't have the cash to fund a late-stage study of its cancer drug Zybrestat and will pink-slip 11 workers--more than half its remaining staff--as the biotech conserves cash for early-stage work. Its shares, which traded at a stratospheric $50 just two years ago, slid more than 20% on the news and were trading at $1.37 by mid-morning. South San Francisco-based Oxigene had been hoping that a Phase III study of the lead drug for anaplastic thyroid cancer would offer pivotal proof that the drug could fight cancer by destroying blood vessels feeding tumors. But it says a Phase II study in non-small cell lung cancer will continue. And it hopes to conserve assets for its most promising early-stage work. Oxigene has been ailing for some time now. In early 2010 the biotech laid off half of its staff, which then numbered 41, and earned a "going concern" warning from its auditors. "Oxigene's management and board have determined that the optimal course of action is to focus on advancing our earlier stage clinical development programs while completing the trials we or clinical investigators have initiated," said CEO Peter Langecker. "We were hopeful that we could further the development of Zubrestat in anaplastic thyroid cancer with internal financial resources, but, in light of the challenges in funding such a rare orphan disease, that is not possible at the present time." - check out the Oxigene release
- here's the Dow Jones report Related Articles:
"ASCO effect" drives up shares of troubled OXiGENE
OXiGENE axes half its staff, halts enrollment in restructuring
OXiGENE filing includes going concern opinion Read more about: layoffs, OXiGENE
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4. Beleaguered Xoma CEO Engle turns in his walking papers
About 5 months after Xoma's ($XOMA) lead drug flamed out in a crucial mid-stage study, Steve Engle has resigned as CEO and chairman of the beleaguered biotech. The company quickly tapped board member John Varian as interim CEO and W. Denman Van Ness, the biotech's lead independent director, as chairman as it launched a search to fill the top spot. Back in March, Xoma's lead drug spectacularly failed a Phase IIb diabetes study, an event that quickly wiped out 37% of the biotech's market value. The trial was designed to track a drop in blood sugar in 421 diabetics assigned to either monthly injections of Xoma 052 or a placebo. But investigators failed to see any significant improvement in the drug group compared with placebo over 6 months of treatment. Engle worked hard to give the data as much of a positive spin as possible, but a number of analysts harshly criticized his leadership. The company's interim leader is staying publicly upbeat about its future. "Given our talented, capable management team, Xoma is well-positioned today to advance its product development programs led by Xoma 052, and we are prepared to maintain positive momentum in all of our core areas during this transition," Varian said. "Key pieces are in place that allow us to achieve our goal of discovering, developing and commercializing our own products in specialized U.S. markets, and we are presented with an opportunity to take a fresh look at our business, potentially finding additional ways to build value in the Company and for our shareholders." - here's Xoma's release Related Articles:
Xoma shares blitzed after lead drug flunks key diabetes study
Xoma snags $505 million pact on its top drug prospect Read more about: Xoma, XOMA 052
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5. Delcath shares slump after chemo system fails to deliver in PhII cohort
Shares of Delcath Systems ($DCTH) slumped 11% this morning after the drug delivery company said its chemosaturation system did not prove effective in a small, mid-stage trial involving a cohort of colorectal cancer patients. Delcath's system is designed to concentrate a burst of chemotherapy at a targeted organ, improving the chances of a successful treatment while minimizing damage to healthy tissue. But when researchers used it to deliver melphalan on 16 patients with very advanced cases of colorectal cancer liver metastasis, the treatment failed to trigger any significant responses. The company said that the patients "had been heavily pre-treated with numerous chemotherapeutic and regional modalities that, along with anatomical and disease-related factors in a few, prevented sufficient melphalan exposure." Delcath says it will try again. "While the efficacy signal from this study was inconclusive due to the factors mentioned above, we believe there is solid clinical and scientific justification to conduct a new Phase II trial in a well-defined metastatic colorectal patient population who are likely to benefit from chemosaturation with percutaneous hepatic perfusion," says CEO Eamonn P. Hobbs. - see the Delcath release
- and read the Reuters story Related Articles:
Delcath in a tailspin after FDA punts back NDA
Delcath shares shoot up on promising trial results Read more about: chemotherapy, Delcath, liver cancer
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Also Noted | This week's sponsor is Novella. |  | Your goal is to enable people to enjoy life's special moments, and we're proud to join you in your pursuit. Our promise is to match your clinical trial specifics with resourcing insight and strategy that moves your program's potential forward.
See how at novelladreamteam.com |
SPOTLIGHT ON... ReNeuron cleared to proceed with groundbreaking stem cell study An independent monitoring board has given ReNeuron a green light to continue with a pioneering study in which stem cells are being injected into the brains of stroke victims. After reviewing the responses of the first three patients, the biotech will now try a higher dose. "Data from the laboratory safety tests, neurological examinations and neurofunctional tests conducted thus far indicate that the ReN001 treatment is safe and well-tolerated at the initial dose," said the U.K. company. Story  @FierceBiotech: Analyst: Benlysta's shortcomings offer blockbuster opening for new lupus drugs. News | Follow @FierceBiotech
@JohnCFierce: Give the big media groups a Ph1/2 cancer drug story success and it spreads like wildfire. Diabetes, etc? Not so much. | Follow @JohnCFierce @RyanMFierce: Just saw this report about a small EDC player called MedNet Solutions, sort of David and Goliath/Oracle story Story | Follow @RyanMFierce > Pfizer says it's extending its controversial tender offer for Icagen by 24 hours as it tries to round up a relatively small number of shares needed to complete the transaction. Report > GeoVax, which is developing HIV vaccines, says the NIH has increased its annual award from $3.6 million to $4.4 million. GeoVax release > Medimmune president Peter Greenleaf is taking the helm of a new authority which will handle the state of Maryland's investments in tech companies. The state is auctioning off tax breaks and using that money to seed startups. Report Pharma News
@FiercePharma: Serious infections in AMD patients injected off-label with Avastin. Supports Genentech case that repackaging=risky Report | Follow @FiercePharma > FTC report IDs new twist on pay-to-delay. Details > Tarceva's new European OK points up Roche's targeted goals. Article > Bain, 2 drugmakers still in race for GSK consumer portfolio. Report Manufacturing News > Promega adding molecular-biology capacity with new plant. More > Fareva moves into U.S. with Pfizer plant buy. Story > Dairy JV nabs India's excipients maker Brahmar. News > Two CMOs to cut more than 100 jobs in NY, Ireland. Report > BASF raises excipient, API prices another 10%. Article > Baxter pumps up lyophilization capacity at Halle plant. Details Vaccine News > New strain of H5N1 lacks vax protection. News > Emory University recieves $26M from NIH. Story > Infant rotavirus shots may benefit the unvaccinated. Report > IOM: Vaccines cause very few side effects. Article > CDC: Teen HPV vaccination rates lagging. Details And Finally... Researchers say they have created tiny devices that can be implanted in hypoxic tumors to generate oxygen, boosting the killing power of radiation and chemotherapy. Release > Webinar: Active Directory & the Cloud for Biotech & Pharma Sept. 21, 2pm ET / 11am PT Biotech and pharmaceutical companies are leaders cloud/SaaS technology adoption. This webinar will discuss the pros and cons of extending Active Directory to Cloud/SaaS Apps for single sign-on and automated provisioning/de-provisioning. Register today. > Inside the mHealth Revolution with Welch Allyn: Realizing the Potential of Connected Devices, September 22, 11am ET / 8am PT After launching a line of connected devices, Welch Allyn immediately viewed it as an opportunity to transform their business. In addition to leveraging connectivity to reduce costs and improving device uptime, Welch Allyn could now generate new sources of revenue with value-added services based on their collected device data. Learn how Axeda enabled Welch Allyn to transform successfully. Register Now!
| > Roche Colorado Peptide Symposium - September 12 -14 - Boulder ,CO RCCPS 2011 is the premier event of its kind focusing on peptide drug development. The symposium features presentations on clinical peptides, peptide drug delivery systems and formulation and advances in synthesis and analysis of peptides. Join us at the St Julien Hotel and Spa in the Rocky Mountain foothills to learn more about developing tomorrow's peptide based therpaeutics. Full details. > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY IS THIS BIG PHARMA'S LAST DECADE? Hear from leading executives such as Biogen's CEO George Scangos, BMS's CEO Lamberto Andreotti and J & J's Tom Heyman at PSA, the only conference to deliver detailed strategic analysis on the biopharma subjects you need to understand now. www.windhover.com/psa > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011 "Cancer Immunotherapy: A Long Awaited Reality" is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy. For information, please email info@mdbpartners.com or contact Michael Becker or Janet Dally of MD Becker Partners at phone (267) 756-7094. To register or for more information, visit www.regonline.com/mdbpartners > 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK Take your place at the table with global leaders, put your company in the spotlight and help define the future of medicine. Join us for BioPartnering Europe in London this October. Visit: http://www.techvision.com/bpe > LES Meeting: Network with Top Licensing & Business Development Execs! - October 16-19 - San Diego, CA Meet your next partner and connect with execs from Bayer, Celgene, Eli Lilly, GSK, Merck, Pfizer, Roche, Shire, Takeda and more! Featuring Roger Longman and Ed Saltzman on value creation in biopharma plus sessions on emerging markets and dealmaking. Save $100 with code FierceBiotech. Register now! > BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA BioNetwork is the key industry biopharma partnering event that provide the essential meeting place for pharma and biotech companies to develop relationships and move programs forward. Get 25% off with code 10386XZ88EN. For more info and to register now, visit www.bionetworkus.com, call 888-482-6012. > Canadian Annual Meeting 2011: New Models - New Frameworks - New Partnerships - November 1-2, 2011 - Ottawa Ontario, Canada Fostering Innovation to Facilitate Market Access! Drug development, regulatory oversight, and traditional healthcare partnerships continue to evolve due to the continuous emergence of new scientific approaches such as biomarkers and individualized medicines; health care reform; technological advances; and the interplay between safety pharmacovigilance and effectiveness research. Canada must foster innovation to remain competitive and facilitate market access. Share insights and exchange information on how these changes present opportunities to those prepared to meet them. Register Today!
| > Capitalizing on the Outsourcing Option - New Fierce eBook Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.
> Free White Paper: The FDA Review Process: a Technical Look Navigating eCTD regulations is easier said than done. Same goes for assembling and reviewing applications. This white paper covers the full FDA review process to help you create an application that is technically sound, structured correctly, and most importantly, is ready for agency review. Download.
| > Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics Regulus Therapeutics Inc. is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus seeks a motivated 6 plus years of drug development experience to join our efforts in translating microRNA biology into human therapeutics. The position requires proven ability to work in a fast-paced biotech environment. Read more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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