Friday, December 14, 2007
"two members of the FDA's advisory committee who opposed the drug's approval -- Howard Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan -- had conflicts of interest.
"There is reason to believe that serious ethics rules were violated by two FDA advisory panel members in their decision, and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time," said the letter, signed by Reps. Mike Michaud, D-Maine; Dan Burton, R-Ind.; and Tim Ryan, D-Ohio.
The congressmen said Scher was a lead investigator for a competing cancer drug..."
Friday, November 23, 2007
SEATTLE, Nov 21, 2007 /PRNewswire-FirstCall via COMTEX/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) , announced that cumulative preliminary results of a phase I trial combining cisplatin with brostallicin in patients with solid tumors that had relapsed or were resistant to front-line treatment were presented at the Highlights in Oncology meeting in Naples, Italy, on Tuesday, November 20, 2007. Cristina Geroni, Ph.D. of Nerviano Medical Sciences (NMS), which developed brostallicin, summarized the basis for the phase I trial design. The trial is based on data demonstrating tumors with high levels of GSH/GST, common in platinum-resistant disease, are more susceptible to the killing effects of brostallicin. High levels of GSH and GST are associated with resistance to most standard chemotherapy drugs
"Our phase I and II experience with brostallicin in over 160 patients demonstrates encouraging anti-tumor activity in a variety of solid tumors, with more than 50% of the patients experiencing at least disease stabilization," said Steven Weitman, M.D., of Systems Medicine.
The preliminary results from the first 21 patients treated in the phase I combination trial with cisplatin showed similar results, with 14 of the patients experiencing stable disease and half (50%) of those 14 patients having durable stable disease for more than six cycles of therapy. Toxicities were mainly hematological and were manageable and reversible in this heavily pretreated patient population
Cell Therapeutics stock falls on treatment study results
Seattle's Cell Therapeutics Inc. reported the results of an early-stage study of a cancer treatment, which combines two drugs, brostallicin and cisplatin, Wednesday. Of the 21 patients with tumors treated in the study, 14 did not show any changes -- positive or negative -- in the progression of their cancer. Cell Therapeutics said side effects were manageable and the company expected to advance its studies. The company's stock fell about 17 cents, or about 6 percent, to close at $2.38 on the Nasdaq stock market.
I believe it was John Allen Paulos who pointed out the medical science can be easily corrupted by psuedoscience. Sick people can either get better, stay the same or get worse. The first 2 situations can be attributed to your drug. Once you apply statistics you have protected yourself with "science". Two thirds of the patients in the Cell Therapeutics study stayed the same. They did not get better. Is this positive news?
More on CTI
Wednesday, November 14, 2007
I've been silent for so long waiting for one big write-up and here the Seattle Times has done it for me. But I will make a few comments regarding the future of Seattle Biotech. The Accelerator companies will soon be facing tougher customers now that they have obtained multi-million dollar payoffs. Of course their investors assume they are just taking off. Cargo Culters know that the main goal is to get paid. The secondary goal is to get out before the S hits the fan. 2008 will be a critical time for VLST and Spaltudaq. Homestead may have already disappeared without any official notice. No thoughts on the others.
So I raise a glass and toast the Cargo Cult Airport otherwise known as Seattle Biotechnology. Many a flight was cancelled or delayed this year. But we'll keep looking up. The Cargo Cult Scientist is always on the lookout.
Thursday, July 12, 2007
Point Therapeutics (POTP) Cuts 76% of Work Force. Recent interim clinical results led the Company's Independent Monitoring Committee to recommend stopping the Company's two Phase 3 talabostat studies as a potential treatment for patients in advanced non-small cell lung cancer, and the talabostat clinical development program was subsequently put on clinical hold by the FDA.
ImClone Systems Incorporated (IMCL) Says Erbitux Fails in Lung Cancer Trial More...
Endo Pharmaceuticals (ENDP) Says Patch Fails 2 Late-Stage Trials; Shares Fall More...
Antisoma PLC (ASM.L) and Novartis Corporation (NVS) Drug Fails in Ovarian Cancer More...
Amgen (AMGN) (Jobs) and Daiichi Sankyo, Inc. Reach Deal on Bone Antibody More...
Monday, July 02, 2007
ZymoGenetics Establishes Global Collaboration With Bayer HealthCare for Development and Commercialization of Recombinant Human Thrombin6/19/2007
ZymoGenetics to receive up to $198 million plus royalties, including up to $70 million in 2007
Bayer HealthCare acquires product rights in all markets outside the U.S..
Sunday, July 01, 2007
Monday, February 05, 2007
LONDON, Feb 1 (Reuters) - AstraZeneca Plc (AZN.L: Quote, Profile , Research) plans to cut some 3,000 jobs, or 4.6 percent of its global workforce, to ensure future profit growth as generic competition bites and some key drugs start to mature, the company said on Thursday.
ZURICH, Feb 5 (Reuters) - Swiss drug maker Roche (ROG.VX: Quote, Profile , Research) plans to restructure its research and development activities around therapeutic areas to speed up decisions and increase efficiency.
A hard rain is falling. The scientists that are chucked out of the universities are not getting the job done. They are failing time and time again. They are using their scientific credentials to become businessmen. They are leaving the hardest part up to underlings.
A new paradigm must take shape. Scientists must return to the laboratory. They must figure out how to run clinical trials. The age of scientists as businessmen must end. Science is the way. The old way has brought about a hard rain, as Bob Dylan would say. A weeding out process must take place. Those who survive must emerge as scientists.
Monday, January 29, 2007
Wednesday, January 24, 2007
Monday, January 22, 2007
Now CTI, a desperate company, is vying for DOR BioPharma, Inc.
Pfizer, the world’s largest pharmaceutical company, said it would cut manufacturing sites in Brooklyn and in Omaha and would seek to sell a third site in Germany. It would close three research sites in Michigan and said it hopes to close one in Japan and another France.
Pharmaceutical industry analysts have generally been welcoming cutbacks by Pfizer but have said that while cost-cutting is beneficial, the company needs to resume growth by bringing new products to market. Still, Pfizer’s shares were trading down about 1 percent this afternoon.
Pfizer has been suffering from the loss of patent protection on key drugs like the antidepressant Zoloft and the antibiotic Zithromax. Sales of both drugs plummeted more than 70 percent in the fourth quarter of 2006, the company reported today.
At the same time its laboratories have had difficulty coming up with new hits. The company suffered a huge blow in December when safety concerns prompted it to halt development of torcetrapib, a cardiovascular drug that it considered the most promising experimental drug in its pipeline.
The number one drug company in the world today, with billions and billions of dollars cannot come up with new useful drugs. With all of the advances in biological science over the past few decades you would think it would be easier.
The truth about drug science is that scientists all work in cubicles, attend meetings and write reports. They do not go into the lab. After obtaining their PhDs they go out and do what they do best; they talk. They are trained to write grant proposals. They are trained to defend popular notions that they most likely did not think of themselves. They learn to take a certain tone of voice that makes people think they know what they're talking about.
Thursday, January 18, 2007
BOTHELL, Wash., Jan. 18 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) today announced the pricing of an underwritten public offering of 3.25 million shares of its common stock at an estimated total public offering price of up to approximately $42.9 million.
On this news Nastechs stock plunged 94 cents (down 6.69%) to finish the day at 13.12. I'm no stock market genius but offering a stock currently valued at 13.12 for 13.20 might be a hard sell. Time to learn about the old stock market and how it works. Lets keep an eye on this deal.
Think of Nastech as a Cargo Cult airline that carries piles of cash for the investors who are waiting in the Cargo Cult airport lobby. Each of their flights, PYY, PTH, calcitonin, have been delayed. The siRNA airplane is still waiting for take off at an undisclosed location (does this plane really exist?). The investors see someone making their way to the information booth. What could it be? Positive clinical trial results? A new break through in siRNA research? Ewww the anticipation!!!They want more money? Son of a...
The 6 months stock chart tells the story of investor patience.
P.S. Nastech seems to be good at raising the stock price when it's desparately needed. Day traders should take a risk and buy in the morning and sell by the end of the day.
Tuesday, January 16, 2007
This is a cargo cult analysis!
If there are always 50% men and 50% women then a study of men should also indicate that 51% of men live without a spouse as well. In a third and seperate study of married people we should find that 49% of the people who respond to the survey are married.
It's probably true that a greater percentage of Americans are not married these days. You can just look around however and add up your married and single friends and family. Then go back to a previous generation. What generation had a higher population of married people. Then go talk to everyone you can about why they think they are single. Talk to the old people about why they stayed married or why the never married. Wouldn't that be more informative?
Monday, January 15, 2007
Mike Nifong, the prosecuter behind the Duke lacrosse sexual assault case is the type of person who worries me. He was six weeks away from an election when the Duke case came up. Durham voters are divided between black and white. Nifong promised black voters that he would not let the Duke case drop. He indicted two of the players two weeks before the election and narrowly won.
Nifong had the accuser chose from photos of the 46 white lacrosse players on the team—a multiple-choice test with no wrong answers. He was also aware that there was no DNA evidence linking any of the men to this woman. What he wanted however, was to get re-elected. He acheived his goal.
So how does this relate to Cargo Cult Science. It is about human ambitions. If there is a Cargo Cult airport there are going to people running the airport. How does one get to be an authority when no airplanes have ever landed? In Biotechnology we rely on college degrees, patents, publications and a number of other achievements losely related to scientific work. We often times run into problems discovering new drugs so we change the rules. We set up a long list of candidates and select a few to hammer through. This is just like the 46 pictures of the Lacrosse team. There were no decoys set up to shed light on the decision process. The DNA evidence handling is another method used. When negative data comes up you just don't talk about it. Gone. Simple.
Some people get caught like Mike Nifong. His Cargo Cult leadership skills were too obvious. He wasn't powerful enough to ignore his critics. The lesson is for the public. When we see George and his ilk lying and cheating we must insist that the system be changed. People will never change. If we change the system people like Bush and Nifong will cease to rise up the chain of command.
Thursday, January 11, 2007
Wednesday, January 10, 2007
BOSTON - Former Massachusetts House Speaker Thomas Finneran on Tuesday resigned from his $416,000-a-year job as president of a biotech industry trade group, days after he pleaded guilty to obstructing justice during a redistricting lawsuit.
The board of the Massachusetts Biotechnology Council accepted his resignation, effective immediately. Finneran had taken the job in 2004 after resigning his legislative position.
In exchange for Finneran's guilty plea, prosecutors dropped three perjury charges.
As part of the deal, Finneran admitted making false and misleading statements under oath during his 2003 testimony in the voting rights lawsuit when he was asked whether he had seen and reviewed a redistricting plan before it was filed with the House clerk. Finneran had repeatedly denied doing so.
WASHINGTON, Jan 10 (Reuters) - The U.S. Food and Drug Administration on Wednesday urged a number of pharmaceutical companies to confirm or repeat some studies done for them by a unit of MDS Inc. (MDS.TO: Quote, Profile , Research) (MDZ.N: Quote, Profile , Research) from 2000 to 2004.
FDA said inspections of MDS Pharma Services had raised questions about the validity and accuracy of studies that measure the level of a drug in a patient's blood and could have been used as part of the basis for FDA approval.
Shouldn't the FDA conduct these types of audits before they approve a drug? Shouldn't they insist that the studies be repeated?
Tuesday, January 09, 2007
LOS ANGELES & WORCESTER, Mass.--(BUSINESS WIRE)--CytRx Corporation
(NASDAQ:CYTR - News) today announced that it has contributed its RNA interference (RNAi) assets to RXi Pharmaceuticals Corporation (RXi), which is co-owned by CytRx and several world leaders in RNAi technology. RNAi has been shown to effectively interfere with the expression of targeted disease-associated genes with great specificity and potency. Subsequent to this contribution, CytRx owns approximately 85% of the outstanding stock of RXi, with the remainder owned by RXi's anticipated scientific advisory team. RXi is a "pure play" RNAi company dedicated to developing proprietary RNAi therapeutics and, in addition to current industry leader Alnylam Pharmaceuticals, RXi will be one of the few companies focused exclusively on developing and commercializing products based on RNAi technology. Pending consent from their research institutions, RXi's scientific advisory board will include four leading scientists who have played major roles in discovering and defining the RNAi field:
Craig C. Mello, Ph.D. received the 2006 Nobel Prize in Physiology or Medicine for his co-discovery of RNAi. He is the Blais University Chair in Molecular Medicine at the University of Massachusetts Medical School (UMMS), a Howard Hughes Medical Institute Investigator and a member of the National Academy of Sciences. His RNAi findings were recognized as the 2002 "Breakthrough of the Year" by Science magazine. Gregory J. Hannon, Ph.D. is a Howard Hughes Medical Institute Investigator at Cold Spring Harbor Laboratory. His laboratory is credited with discovering the mechanism of RNAi in human cells (RISC/siRNA) as well as discovering short hairpin RNAi (shRNAi). Dr. Hannon is also a leading expert on oncogene pathways and was formerly an advisor to Alnylam Pharmaceuticals.
Tariq M. Rana, Ph.D., is Professor of Biochemistry and Molecular Pharmacology and Founding Director of the Program in Chemical Biology at UMMS, and has previously advised a number of biotechnology companies including Sirna Therapeutics, where he served as a member of their Scientific Advisory Board. Dr. Rana discovered key technology for the chemical stabilization of RNAi and has obtained RNAi activity in animals by local and systemic delivery.
Michael P. Czech, Ph.D., is Professor and Chair of the Program in Molecular Medicine at UMMS. He has authored more than 250 papers in the field of insulin action, and was awarded the American Diabetes Association's Banting Medal for Scientific Achievement in 2000 as well as the ADA's Albert Renold Award in 2004. He has used RNAi to discover a number of genes involved in diabetes and obesity.
RXi intends to build on CytRx's RNAi therapeutics programs for the treatment of human diseases, initially focusing on neurodegenerative disease, oncology, type 2 diabetes and obesity. (biotech cargo cult most popular diseases!) The contributed assets from CytRx consist primarily of several key licenses to early fundamental RNAi technologies from the University of Massachusetts Medical School (UMMS) and the Carnegie Institution of Washington, as well as equipment and other tangible assets from CytRx's Worcester, Massachusetts laboratory. The licensed technologies include pending patents on RNAi target sequences, chemical modifications and delivery to cells, and field-specific licenses to a seminal patent application on chemical modification of RNAi filed in 1992 by UMMS and invented by Tariq M. Rana, and to the "Tuschl I" patent. The technologies also include exclusive licenses to patent applications that disclose gene targets for diabetes and obesity, including RIP140, which has been shown to be a master regulatory gene for metabolism in fat cells.
"CytRx has been acquiring, developing and consolidating its RNAi therapeutic assets since 2003. These assets have been created by research performed at UMMS and CytRx's laboratories from 1998 through 2006. We are now moving these assets into an RNAi company exclusively committed to accelerating the commercialization of second-generation RNAi-based therapeutics addressing important diseases, including type 2 diabetes and obesity. We believe this transaction represents the best strategy for CytRx and its shareholders to benefit from the potential value of these RNAi assets, as RXi will have a single, focused purpose positioned to compete directly with other leaders in the industry," said Steven A. Kriegsman, President and Chief Executive Officer of CytRx. The Cargo Cult Scientist believes the CytRx's RNAi program was dragging along with no real results. They are dumping it off in a business way.
Tod Woolf, Ph.D. will serve as Chief Executive Officer of RXi. Dr. Woolf has 20 years of experience developing and commercializing innovative biomedical technologies, and is a recognized leader in RNA therapeutics. He previously worked at numerous biotechnology companies including Ribozyme Pharmaceuticals (now Sirna Therapeutics), where he co-developed a number of lead therapeutic RNA compounds and developed Genbloc(TM) RNA technology, which was spun out to create Atugen. He founded and served as Chief Executive Officer of Sequitur, an RNAi company acquired by Invitrogen in 2003. At Sequitur, Dr. Woolf co-invented and commercialized STEALTH RNAi, one of the most widely used second-generation RNAi research products. Also at Sequitur, he established collaborations with over a dozen major pharmaceutical companies. More recently, Dr. Woolf served as an advisor to Signet Laboratories prior to its acquisition by Covance, and has advised ProNai, Praecis Pharmaceuticals and Invitrogen. Dr. Woolf earned his Ph.D. in biology at Harvard University where he performed seminal work in the then-nascent field of RNA therapeutics. He has recently been serving as a consultant to CytRx in connection with the formation of RXi.
"I have been impressed with Craig Mello's insight and integrity since we met during our graduate program at Harvard and during our work together at Sequitur. It will be an honor to work with him and Drs. Rana, Czech and Hannon. A void was created in the industry by Merck's acquisition of Sirna Therapeutics. RXi intends to fill that void," said Dr. Woolf. "The announcement of our extraordinary scientific advisors and senior management team is the first step in our quest to lead the RNAi therapeutics field," added Dr. Woolf.
RXi has named James Warren, MBA as Chief Financial Officer. Mr. Warren has more than 30 years of experience in financial and general management in rapidly evolving technology-based companies. From 1991 to 1998 he served as Vice President and Corporate Controller for Genzyme Corporation, where he managed an international staff of 120 finance professionals. He also served as CFO of Aquila Biopharmaceuticals, Inc., Harvard BioScience, and ActivBiotics, Inc.. He has been involved in raising over $1 billion at the various biotechnology companies where he was employed. Mr. Warren earned his MBA in operations and research at Boston University, and has recently been serving as a consultant to CytRx in connection with the formation of RXi.
"The clinical potential of RNAi technology is garnering strong attention from the pharmaceutical industry, making the timing excellent to acquire these RNAi assets from CytRx. We believe that RXi's unique assets and pure-play structure make it well-suited to pursue collaborations and compete directly with other leading RNAi companies," noted Dr. Woolf.
So many scientists, so much money, so... where are the drugs?