* from DXer … documents related to interactions between Dr. Bruce Ivins and University of Michigan researchers
Posted by DXer on March 1, 2010
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The New York Times says the FBI’s anthrax case has “too many loose ends.” Find out where some of those looses ends might have originated in my novel CASE CLOSED. Sure it’s fiction, but many readers, including a highly respected member of the U.S. Intelligence Community, think my premise is actually “quite plausible.”
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******
from DXer …
documents related to interactions
between Dr. Bruce Ivins
and University of Michigan researchers
******
… see documents below …
from DXer …
- Records recently provided by the US DOJ suggest that Dr. Ivins did not know that one of the two researchers coming was not a US-citizen.
- Tarek Hamouda, the head of a DARPA project, was from Cairo, Egypt and had a green card.
- Permission was granted after his arrival to work with Bruce Ivins in the B3 laboratory.
- The researcher, Tarek Hamouda, and his co-inventor, James Baker, were working on a decontamination agent that later was tested at the US Capitol clean-up and pitched to postal workers as a hand cream.
- Lab tech Michael Hayes accompanied Dr. Hamouda to do the work with Dr. Ivins in May 1998.
- The Ann Arbor researchers thanked Bruce Ivins for supplying them the Ames and also thanked Patricia Fellows, Mara Linscott, and Arthur Friedlander for technical assistance.
- DXer has reported that a lifelong childhood of Dr. Hamouda, “Tawfiq” Hamid, has published on his experience of being recruited into the Egyptian Islamic Jihad by Ayman Zawahiri in a room set aside for that purpose at the Cairo Medical School.
- Dr. Hamid consults with the Intelligence Community.
- The recruitment occurred while he and Dr. Hamouda were both attending Medical school. Dr. Hamouda graduated in December 1982 and then got his PhD from Cairo Medical in 1994. By 1997 he was in Ann Arbor and head of the DARPA project.
- Before 911, Dr. Hamid called his friend Dr. Hamouda to ask about patents and Dr. Hamouda reportedly said it was all in the marketing.
- DXer reports that Dr. Hamid told him that Dr. Hamouda would visit Cairo from Khartoum and they would go to the comic store together with Dr. Hamid’s brother, a St. Louis MD.
- DXer asks:
- Why wasn’t Dr. Ivins told that he was being asked to supply virulent Ames to a non-citizen?
- Why are the nearly 20 pages concerning that research not provided until 2005?
- Why is it Dr. Ivins’ fault that a non-citizen was sprung on him without notice?
CASE CLOSED ... what really happened in the 2001 anthrax attacks? 
DXer said
The fictionalized National Geographic tv yarn about the Amerithrax investigation of Bruce Ivins — inspired by actual events — has a curious brief snippet. It involves a search of USAMRIID by the squad that was investigating a foreign lead. Each squad, we knew from the start of the investigation, was to stay in their own lane. The handsome muscled Ryker asked the fellow who headed the squad investigating foreign leads — who was retrieving massive documents from USAMRIID — what he was doing there. (And the fellow responded that Ryker should keep his eyes on his own paper, or words to that effect). What would have been been doing there? Would he have been investigating the lead to the Egyptian scientist from the University of Michigan who Ivins had supplied Ames? That scientist did the research in the BL3 at USAMRIID, and at LSU and elsewhere. I emailed the fellow to ask if we knew former or current members of the Egyptian Islamic Jihad in common but he didn’t respond.
Or did it involve the scientist who shared the suite with leading Ames researchers at the DARPA-funded biodefense center at GMU. The one with the Russian defector Ken Alibek and the members of his company. His name is Ali Al-Timimi. Imam Ali Al-Timimi, whose counsel Jonathan Turley described him as an “anthrax suspect” in a court filing. GMU shared facilities with ATCC, which had the largest biological repository in the world. I once spoke to Ali’s gracious wife Ziyana but she was not authorized by counsel to answer any questions.
DXer said
R. Scott Decker wrote in his book published last year that “my PhD from Michigan had been my ticket in.” — “Recounting the Anthrax Attacks.”
Comment:
The fellow calling around gaining assurances that all samples had been sent in, R. Scott Decker, got his PhD at the University of Michigan. Given the patents said that the Michigan researchers were supplied virulent Ames, what did Decker do to confirm that they they in fact had not been supplied Ames (in contrast to the claim that they had been in the numerous sworn patents). Or rather, what did Scott do to confirm that they only had only ever done the research at USAMRIID, LSU, Dugway and Johns-Hopkins.
What did Michael Hayes say? Michael was a technician who was one of the pair that came from the University of Michigan. I called Michael Hayes, the technician who worked alongside Bruce and asked. He said “You don’t want to know.” But I do want to know.
I also called the illustrious James Baker and he emphasized that the research was done under the supervision of Bruce Ivins, not him. James had no hands-on responsibility. He suggested that it would be illegal for Michigan to have it and therefore they wouldn’t. He apparently was unaware that anthrax was a BL-2 pathogen in liquid form before 9/11 and Michigan did have the required BL-2 labs. So the transfer only would have been illegal if one was made and no EA-101 had been filled out. (EA-101 was a new law and researchers took a while to embrace it; Ivins said that transfers made at USAMRIID prior to 2002 were not recorded.
I emailed Dr. Hamouda but he did not respond.
Anthrax, Al Qaeda and Ayman Zawahiri: The Infiltration of US Biodefense
http://www.amerithrax.wordpress.com
DXer said
The documents about the visit by the University of Michigan researchers appear to have been faxed to the FBI by Dr. Friedlander, after he obtained them from Bruce Ivins.
USAMRIID researchers make breakthrough with anthrax vaccine
http://www.fredericknewspost.com/news/health/usamriid-researchers-make-breakthrough-with-anthrax-vaccine/article_5fbf4f0c-f9c2-5711-83d6-2bfcc9ececce.html
Frederick News Post (subscription)-13 hours ago
Researchers at Fort Detrick are seeing promising results with a new anthrax vaccine, which could be the first major advance in the field since …
The discovery comes 15 years after the 2001 anthrax mailings. Envelopes containing anthrax bacteria in powder form were mailed to U.S. senators and news media organizations.
The late Dr. Bruce Ivins, a researcher at USAMRIID, was the FBI’s main suspect in the anthrax mailings.
Five people who came into contact with the bacteria died, and 17 more were sickened.
Friedlander said the knowledge of those mailings still motivates his work.
“There’s still a threat, and we’re trying to optimize the protection,” he said.
DXer said
Colonel Elliot should have obtained these documents in November 2001 upon the IG’s inspection. Instead, it appears that they were first obtained in February 2005. Colonel Elliot’s civil deposition can be requested under FOIA.
DXer said
The former DARPA-funded Zawahiri associate supplied virulent Ames by Bruce Ivins had his decontaminant tested against Bacillus subtilis (aka Bacillus globigii – BG) at Dugway.
http://www.amerithrax.wordpress.com
Antimicrobial nanoemulsion technology was developed by Dr. James Baker at the …technologies at Dugway, UT, against an anthrax surrogate, Bacillus globigii .
(Reformulated NanoBio Nontoxic Hard Surface Sanitizer/Disinfectant …
cfpub.epa.gov › … › Extramural Research › Research Project Search)
Did Dr. Majidi know Tarek while at Wayne State?
Dr. Majidi dismisses the views of all the notable scientists who criticize an Ivins Theory on the basis that that they knew Bruce Ivins — and thus their professional opinion doesn’t count.
Okay. So under his reasoning, I should ask:
Vahid, did you know Tarek at Wayne State? He did his post-doc there. What years were you there?
For you to not swab suspect labs seems to demonstrate a singularly incurious mind.
At Eastern Michigan and Wayne State, you learned that science provides answers but then generates additional questions.
The key is to have good judgment on what might be probative. You have said that most of the non-traditional forensic methods you used did not bear fruit.
Moreover, you have withheld all the tradiitional forensic reports — and those reports, when they finally are produced, will be shown to have been exculpatory of Dr. Ivins. (see examination of paper, ink, photocopy toner etc.)
Most everyone disagrees with your decision not to swab suspect labs for subtilis.
DXer said
http://www.fiercevaccines.com/story/uks-hpa-lands-64m-anthrax-vaccine-research/2012-10-31
U.K.’s HPA lands $6.4M for anthrax vaccine research
FierceVaccines-by Alison Bryant-2 hours ago
HPA will use its expertise in anthrax vaccine antigens with NanoBio’s adjuvant technology that enables a vaccine to be delivered in fewer … and by an intra-nasal device
DXer said
It was James Baker who arranged the visit for Tarek Hamouda to USAMRIID to work with Bruce Ivins with virulent Ames even though he was not a citizen (unbeknownst to Ivins).
James Baker this month was appointed as senior vice president of its global vaccine business.
http://www.crainsdetroit.com/article/20121009/FREE/121009891#
October 09, 2012 2:16 PM
Ann Arbor biotech NanoBio Corp. names CEO
By Tom Henderson
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Ann Arbor-based NanoBio Corp. announced Tuesday that David Peralta has been promoted to CEO, replacing company founder James Baker, M.D., who recently joined the New Jersey-based drug giant Merck & Co. Inc. as senior vice president of its global vaccine business.
Previously, Peralta, who joined the company in 2006, had been COO and CFO.
Baker will continue to serve on NanoBio’s board of directors.
NanoBio has been one of the most successful fundraisers among local biotech and tech companies, raising more than $80 million in equity capital over the past decade.
DXer said
Excerpt from 2012:
“By Tom Henderson
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Ann Arbor-based NanoBio Corp. announced Tuesday that David Peralta has been promoted to CEO, replacing company founder James Baker, M.D., who recently joined the New Jersey-based drug giant Merck & Co. Inc. as senior vice president of its global vaccine business.”
I used to correspond with James Baker, who became the vice president of Merck’s global vaccine business. He told me that the reason he knew University of Michigan did not have Ames that was virulent was that it was not authorized to have virulent Ames. I could see from his patents involving the virulent Ames supplied by Bruce Ivins that he was a very smart man. So I was surprised that he said something that made so little sense. In any event, James Baker would be someone who might be able to explain the situation with these vials labeled “smallpox.” Had they been irradiated? Richard Ebright, who has closely observed the proliferation of biological agents, would also be highly quotable.
DXer said
James Baker’s statements were especially clueless because he apparently did not realize that prior to 9/11, anthrax in its liquid form was a biolevel 2 pathogen and not biolevel 3 pathogen. So his statement was provably false on its face.
DXer said
These documents about the research that the former Zawahiri associate did with Bruce Ivins in the B3 at USAMRIID were faxed on February 18, 2005. Did the FBI really not know about the research and have these documents until then? Wouldn’t they have obtained the documents pursuant to the late 2001 subpoena directed to the University of Michigan and Louisiana State University? What does Art Friedlander say? What does Martin Hugh-Jones say?
~A said
In your last response that you disagreed with me on the fact that money can buy your way into anywhere… I completely agree with you on that point. And on the contrary have seen and heard where that has been the case in other circumstances… But to buy your way into a government lab/pharmaceutical or out of something big or whatnot is a lack of character, morals, honor and self respect.
On to the bullet points of the FBI document above UCD Date 12-17-2008 BY 60324 UC BAW/DK/TH.
Indication that records provided by the US DOJ suggest that Bruce Ivins did not know the associate was a (Non-US Citizen) …
In response to that I bring up this… What in sam hell is a Foreign National Citizen or not. Being a Non citizen, why would Tarek Hamoudas information not be fully disclosed to the researchers???
Maybe it wasn’t disclosed to Bruce and colleagues, but I bet the Commander of the Base at the time of visits knew about it, just as well as a few others in the Intelligence community. In my opinion that’s a definite.
Next who was it “exactly” that granted him and “Anyone” permission to enter the lab? And. Any other US government Lab that in the instance that any average person were to enter, requiring a Federal BGC and waiting period of 6-12 months…
When was Tarek Hamoudas first written application for coming to the US and knowing full well on both governments accountability that he would be visiting Ft. Detrick and be allowed to have access to the BSL-3 or and part of the lab… And certain the CIA, NSA, NIA would have been aware of their upcoming visits. They may deny it, but that to me would be like saying the sky is not blue…
To not have 24/7/365 closed loop video recording of every single inch of any lab like this is unacceptable Period!
Next to ask, were any of the (Non-US Citizens) that all have visited any government lab were they interrogated by the FBI and given a polygraph for a few hours? Or did other governments disapprove of this? In the wake of things, trying to get to the bottom of things, one would think that any self respecting country, would polygraph and Interrogate anyone that has had any type of access to any lab in the world not just USAMRIID. If no, why the heck not?
How simple would that be to make up some story about being all nice to help and to have other ulterior motives to gain access to Ames or any of the other pathogens in storage.
Personally I’ve seen more security given to body parts in hospital bio-freezers soaking in formaldehyde than what was/has been given to some of the most deadly things in the world that could kill thousands up to millions of people. Again “Unacceptable” Schools have “Zero” tolerance why not the US government on all objectives from biological to politicians… Seems only fair and standard to me.
If I’m not mistaken there are a few Universities here in the US that can all tie into the Ames Strain samples being sent by Bruce Ivins, along with pharmaceuticals and other government agencies that would have known or relevant information that ties directly to those involved with Non-citizens gaining access to US Labs by means of our own government, which I’m inclined to say that this also is perhaps another key piece of the puzzle that is being withheld from the public at the FBI’s records/evidence holding location. Anyone with common knowledge of locations could point out many places that had access to, sent or given live samples of Ames for other uses outside the work scope directive.
Another point to look at… was it a marketing scheme with governments and the pharmaceutical companies trying to make millions on something they needed tested that they all know, “could not be legally done” unless there was a full team planning this all from the very beginning, and those in charge did not want to know any details on how anything would be carried out, just in-case something went wrong, or the obvious that there would still be people that will not stop probing until justice is served on those who did take part or know about this, in any way shape or form…
One of your bullet points talks about “It’s all about the marketing” Humm… That right there would confirm that something is up.
One thing to look at is anyone who was a US citizen, or non-us citizen… Were they really who they were supposed to be, or were they “really” someone else??? Reference high tech movie magic/makeup/mask… Along with setting up extra bank accounts in a certain person’s name, and using someone else’s bank cards or means of money transactions to send anyone who might come looking all over the world and keep hitting dead ends… Theoretically speaking…
Another point is what reasoning is the FBI giving in “them” the FBI not disclosing the other locations?
Even more so, why wasn’t Klein’s strain tested by the FBI at Arizona (ASU) if I remember reading correctly somewhere that is…
Did the FBI exclude other labs from testing/or poly? If so why?
Lastly is no one has claimed responsibility for the attack… Even if it were Bruce which I believe he was just the wrong person at the wrong place at the wrong time, he would have made it clear why he did it, if he did which I don’t think is the case at all, along with anyone else with any common sense. I believe he would still be alive today, if not for the FBI’s sloppy work and mistakes all over this investigation.
Also any BAU or psych profiler would know that nothing at all fits with Bruce even being the person who did all this…
Anyone who commits suicide leaves something behind, especially if they did something that tragic. It’s textbook profiling, that they would want the credit, and then would highly likely give a reason why it was done. It’s obvious that this is not the case here…
DXer said
Professor Guillemin says that Art Friedlander knew of the research for DARPA making “pure spores.”
“Others at USAMRIID, certainly John Ezzell and Art Friedlander, knew better but remained silent and let the Spertzel claim [that USAMRIID didn’t have equipment] stand…”
It’s Dr. Friedlander who first faxed the 16 pages about the visit by the former Zawahiri associate to work alongside Bruce Ivins, Pat Fellows and Mara Linscott — he faxed the 16 pages, now produced by the FBI, 4 years after 9/11 and the investigation was launched. I believe the delay is explained by the fact that he only then had been given a copy by Bruce. But he could best explain the reason for the 4 year delay.
If Dr. Friedlander knew about the DARPA research involving making a dried powder out of Ames, did the fellow DARPA researcher Tarek working with Dr. Ivins and Dr. Friedlander know? He was a non-citizen and before working alongside Dr. Ivins worked alongside Professor Heba Zawahiri.
Tarek thanked Dr. Friedlander, along with Pat and Mara, for providing technical assistance. He thanked Bruce for supplying virulent Ames.
DARPA researchers like Dr. Ezzell used virulent Ames from Flask 1029.
DXer said
Investigators dismantled a suspected al-Qaeda anthrax lab in an unnamed overseas location and transported it to the USA for investigation, eventually concluding there was no evidence it played a role in the attack.
Panel can’t rule out other sources of deadly anthrax spores
“The (panel’s) overall conclusion that the scientific data did not ‘confirm’ solidly the FBI’s allegation that Dr. Bruce Ivins was the sole culprit is NOT the same thing as implying that the scientific data somehow ‘cleared’ Dr. Ivins,” says an e-mail from biologist Phil Hanna of the University of Michigan-Ann Arbor.
Comment:
Dr. Hanna is certainly a quotable expert. But reporters should interview the researchers from University of Michigan who actually worked alongside Bruce with virulent Ames at USAMRIID to get their take on the report.
ANTHRAX AND AL QAEDA: THE INFILTRATION OF US BIODEFENSE
http://www.blurb.com/bookstore/detail/1443811
100+ graphics –
http://www.anthraxandalqaeda.com
DXer said
DXer said
Judith Miller writes of “What the Russian Spy Story Tells Us.”
http://www.foxnews.com/opinion/2010/06/29/judith-miller-doug-schoen-obama-medvedev-russian-spies-arrests-starbucks-fbi/
But she never told us what Ayman Zawahiri’s book on running covert operations told us.
If it had become known that the Administration had allowed this infiltration — the Bush Administration would never have won a second term.
https://caseclosedbylewweinstein.wordpress.com/2010/03/31/if-it-had-become-known-that-the-administration-had-allowed-this-infiltration-the-bush-administration-would-never-have-won-a-second-term/
See also
Zawahiri’s Correspondence With Infiltrating Scientist Was Part of Parallel Compartmentalized Cell Operation
https://caseclosedbylewweinstein.wordpress.com/2010/02/20/from-dxer-infiltration-of-u-s-biodefense-zawahiris-correspondence-with-infiltrating-scientist-was-part-of-parallel-compartmentalized-cell-operation/
DXer said
Dr. Hamid’s lucid account of being recruited by Ayman Zawahiri in a room set aside for that purpose at the Medical School is found at:
Tawfiq Hamid, INSIDE JIHAD: Understanding and Confronting Radical Islam (May 6, 2008)
http://www.amazon.com/Inside-Jihad-Understanding-Confronting-Radical/dp/0981547109/ref=sr_1_fkmr0_1?ie=UTF8&qid=1267459708&sr=1-1-fkmr0
Along with Archibald Cox and Ralph Nader, he is one of my heros.
Old Atlantic said
Does he have a view on the anthrax attacks? Does he think they are al Qaeda?
DXer said
I didn’t ask him as my purpose was to obtain factual information. I’m also a very shy person and having the presence of mind to ask all the relevant questions often alludes me. He said his brother in St. Louis no longer spoke to him because of his cooperation with the IC. And so talk concerned how to make respectful inquiries of Dr. Hamouda given that Dr. H was not responding to any of my inquiries and Dr. Baker, while responding to emails, was not telling me when the research with Bruce Ivins occurred and University of Michigan failed to provide me any documents.
For that matter, Patrick Easter… at EPA said that EPA had no documents relating to NanoProtect which a simple google I gave the FOIA person showed to be untrue.
I am very disappointed that USG FOIA officers don’t take their job more seriously. Relatedly, a Mr. Gottesman at the EPA similarly chose to bill me $38 / hour before EPA would look for any documents.
Behind every failure of intelligence due to a failure to share information is a FOIA officer writing boilerplate letters denying requests without regard to the terms of the FOIA statute.
DXer said
One needs to distinguish between Al Qaeda and Egyptian Islamic Jihad. They are two different groups. Most EIJ members were opposed to joining Al Qaeda. Ayman Zawahiri in a May 2001 letter sent to colleagues from years earlier explained that the “School” had merged with the contractor but there had been no consultation. Zawahiri just did it on his own.
Then, moreover, there were splinter groups with the Egyptian Islamic Jihad. For example, Yasser Al-Sirri, of the London cell, in 1996 formed The Jihad Movement which was distinct from Vanguards of Conquest. He was consulting Postal worker Abdel-Sattar, the blind sheik’s liaison, in conference calls with Montasser Al-Zayat (who announced anthrax would be used) and Mustafa Hama (the Egyptian Islamic Group military commander). (The IG is much bigger than EIJ).
So given the intention to use anthrax was announced by EIJ shura member Al-Najjar, the EIJ military commander Mabruk and the blind sheik’s lawyer Montasser Al-Zayat, I think of the purpose of the anthrax was as stated when the announcement was made: to retaliate for the rendering of senior EIJ / VOC leaders. In January 2001, the threat was sharpened to say anthrax would be mailed of bail were denied VOC #2 Mahmoud Mahjoub. See Feb. 2001 PDB from the CIA to President Bush cited in the 911 Commission Report. (That PDB needs to be declassified as it is highly relevant as the August 2001 PDB on the “planes operation”). Then Mr. Mahjoub’s bail was denied on October 5, 2001. The mailer dropped what he was doing and rushed to mail the anthrax.
DXer said
Of course, the last thing in the world the Bush Administration wanted the public to learn was that
(1) it was in retaliation for rendering and torture; and
(2) the White House had given Salafist Al-Timimi a letter of commendation for his classified work for the Navy while at SRA.
If it had come to be known, the Bush Administration would not have won a second term. I think the obstacles to a solution were myriad, though, and there are numerous conflicts of interest.
DXer said
September 26, 1998, Saturday – 09:01 Eastern Time
Novavax Anti-Microbial Agent Shown to Destroy Anthrax, Data Presented at ICAAC;
‘New Anti-Microbial Agent Destroys Anthrax, But Doesn’t Hurt Animals or the Environment’ Say University of Michigan ScientistsLEXIS-NEXIS Related Topicsno targeted Topics.
DATELINE: SAN DIEGO, Sept. 26
Novavax, Inc. (Amex: NOX), announced today that BCTP, an antimicrobial “nanoemulsion,” destroyed anthrax spores in two preclinical studies. BCTP inactivated spores both in a culture dish and in mice exposed to anthrax through a skin incision. The data were presented by University of Michigan (U-M) researchers at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego. The studies were directed by James R. Baker Jr., M.D., professor of internal medicine in the U-M Medical School.
BCTP is an emulsion or “nanoemulsion” developed at the Novavax laboratories in Rockville, Maryland, by D. Craig Wright, M.D., chief scientific officer at Novavax, Inc.
In the first study, BCTP inactivated greater than 90% of Bacillus anthracis spores after four hours of incubation. In the second study, which simulated wounds infected with B. anthracis, mice treated with BCTP had greatly reduced skin lesions and swelling compared to untreated mice.
“One of the most remarkable characteristics of this material is its ability to rapidly destroy a wide variety of dangerous bacteria and viruses, while remaining non-toxic to people, animals and the environment,” Dr. Baker said. Concentrated doses of strong disinfectants like bleach or formaldehyde will kill anthrax spores, according to Baker. Unfortunately, they also are toxic to people and the environment, which makes them useless for decontaminating a person, a piece of land or equipment exposed to the bacteria.
“When properly formulated, the components in BCTP form an emulsion of tiny lipid droplets suspended in solvent,” said Dr. Wright. “These lipids fuse with anthrax spores causing the spore to revert to its active state. During this process, which takes four to five hours, the spore’s tough outer membrane changes allowing BCTP’s solvent to strip away the exterior membrane. BCTP’s detergent then degrades the spore’s interior contents. In scanning electron microscope images, the spores appear to explode.”
In recent years military authorities have become increasingly concerned about the threat anthrax and other biological warfare agents pose both to the armed forces and civilian populations.
“Anthrax is often fatal and easily dispersed through air or water,” Dr. Baker says. “We know that countries hostile to the United States have developed strains of anthrax which are resistant to antibiotics and existing vaccines. To counter that threat, the Defense Advanced Research Projects Agency (DARPA), is testing several possible new antidotes — including BCTP.”
University of Michigan plans to conduct additional studies to evaluate BCTP’s effectiveness against inhaled anthrax spores, as well as other bacteria and enveloped viruses. Funding for these studies has come from DARPA’s Unconventional Pathogen Countermeasures Program.
BCTP was developed using Novavax’s proprietary emulsion technology. The technology is currently being tested for additional applications, such as the inactivation of influenza A virus and sperm. In collaboration with the National Institute of Health, spermicidal testing of several of Novavax’s emulsions will begin either late 1998 or early 1999.
Novavax, Inc. is a biopharmaceutical drug delivery company headquartered in Columbia, Maryland. The Company currently has two product candidates in human clinical testing. Novavax’s two lead topical drugs are: ESTRASORB(TM) — a patchless”estrogen replacement cream and ANDROSORB(TM) — a cosmetic-like cream for testosterone replacement therapy in testosterone-deficient men. Also in development is Helicore(TM) — a non-antibiotic, anti-bacterial product designed to eradicate H. pylori, the intestinal bacterium responsible for most cases of peptic ulcer disease. ”
In addition to historical information, statements made in this press release that state the company’s or management’s intentions, hopes, beliefs, expectations or predictions of the future are forward looking statements. Forward looking statements may involve risks and uncertainties, including, but not limited to, uncertainties related to the company’s early stage of development and clinical trials and marketability. These factors are more fully discussed in the company annual report on form 10-K/A for the year ended December 31, 1997.
For additional information please contact Novavax, Inc. or the University of Michigan.
SOURCE Novavax, Inc.
simultaneously by the University of Michigan/
DXer said
The New York Times
October 9, 2001 Tuesday
Late Edition – Final
New Ideas In the War On Bioterror
BYLINE: By ANDREW POLLACK
***
Darpa prides itself on doing long-range, highly innovative research that often fails but can have a huge impact if it succeeds. It was Darpa research that eventually led to development of the Internet and stealth aircraft. An agency spokeswoman said no interviews on bioterrorism were being given. But outsiders and the agency’s own Web site paint a picture of a wide range of projects, some fairly bizarre.
***
Other projects aim at preventing infections or treating them once they occur. Dr. James R. Baker Jr. at the University of Michigan has developed what he and colleagues jokingly refer to as a salad dressing that can kill many types of microbes, including hardy anthrax spores. They say the disinfectant concoction, made of microscopic droplets of soybean oil suspended in water, is safe enough to apply to the skin or to equipment, to spray into the nose to stave off infection and even drink in small quantities.
Dr. Baker explained that when some regular salad dressings are shaken, bubbles of oil get dispersed in the water. Those bubbles contain energy from the shaking, which is stored as surface tension. This energy is released when the oil droplets coalesce again.
Dr. Baker’s disinfectant has extremely tiny bubbles, about 200 billionths of a meter across, which have extremely high energy but are prevented from coalescing by detergent. “But a bacterium is like a big oil droplet and they coalesce with it and blow it up,” he said.
DXer said
Federal Document Clearing House Congressional Testimony
November 8, 2001, Thursday
ANTHRAX DECONTAMINATION
November 8, 2001
Statement of James R. Baker, Jr., MD
Ruth Dow Doan Professor of Medicine and
Director of Biologic Nanotechnology
Chief, Division of Allergy & Immunology
University of Michigan
I am Dr. James Baker, a physician who is the Ruth Dow Doan Professor of Internal Medicine and Director of the Center for Biologic Nanotechnology at the University of Michigan. I am also the head of Allergy and Immunology in the Medical School.
I am a 14-year veteran of service in the U.S. Military, 12 of it on active duty, including service during Desert Storm. With support from the Defense Advance Research Projects Agency, the National Institutes of Health and NASA, my center is applying these technologies to a number of problems in biology including infectious disease therapy and microbial decontamination. I am also the CSO of a startup company, NanoBio Corporation, which is dedicated to commercializing new technologies for antimicrobial applications and decontamination. I have extensively studied the problems involved in preventing illness as a result of bio- terrorism or bio-warfare, and I am pleased to have been invited to testify before the committee this morning.
The Issue of Biological Decontamination
***
2. Despite these technological advances, no building can be sterilized or treated in a way that removes every single spore. Total spore removal is achievable on surfaces, but cannot be done completely in a building given the complexities of the space. Therefore, techniques must be put in place to monitor residual levels of contamination and assure that a medically safe level of residual contamination be maintained.
3. Given the differences in the design of the buildings, each one will require an individual approach. For example, it may not be feasible to use the decontamination techniques that would work for smaller, more contained spaces in a building as large as the Brentwood Post Office. Safety for the environment and surrounding communities must be a priority in this process. However, as experience with the different decontamination approaches increases, it may be feasible to do things that we did not feel were possible a few months ago. We should remember that the UK was able to decontaminate an anthrax-contaminated island.
4. It is very important to remember that these decontamination protocols and processes are truly experiments. Nothing akin to this scale of building decontamination has been tried before, and it is not clear how effective this approach may be. Therefore, it is extremely important to conduct this work as an experiment, with appropriate data analysis. Only with this approach can we learn from this process and improve decontamination techniques for the future. The Process of Safe Reoccupation of a Contaminated Building
As part of this experimental approach, I believe it is important to do two things after decontamination. The first is to provide support to those individuals who will be occupying the building after it is decontaminated. This support should involve both medical and psychiatric care so that each individual feels entirely comfortable reentering and reoccupying the space. Individuals displaced by a bioterrorism attack are traumatized to begin with, and will need additional help with reoccupation. Support groups may be very important in this process. Physicians should be readily available for any perceived problem that an individual may have after moving back in to a decontaminated building. In addition, the experiences of individuals should be recorded prospectively so that a better understanding of reoccupation is obtained. This may help to predict and prevent illness and the more data obtained from these individuals the better prepared we will be to handle these problems in the future.
In addition, it may be particularly valuable to set up a review board of scientists and physicians to evaluate the outcome of decontamination and its effect on individuals who are reoccupying these building. This panel could function like the review board of the Challenger accident, but work on a more rapid manner given the immediacy of electronic communication. This is especially important since it is becoming clear that we don’t fully understand the exposure tolerances for individuals to anthrax spores.
My hope is that these recommendations will help in the approach to decontamination of these buildings and will yield a better result for all involved.
DXer said
United Press International
October 11, 2001, Thursday
Biotech firm has anthrax decontaminant
DATELINE: ANN ARBOR, Mich., Oct. 11
A small biotechnology company says it could produce a non-toxic anthrax decontaminant that could be generally available to U.S. citizens and the military over the next six months.
Nanobio of Ann Arbor said it would use nanotechnology and would also need government funding to work on this decontaminant.
The company also said it can produce nasal sprays that could be applied as a preventive measure before a bioterrorism attack — attacking any deadly anthrax spores as they arrive in nasal passages.
With substantial federal support, the nasal spray could be available to the civilian population in about 24 months, Ted Annis, Nanobio’s CEO, told United Press International.
“We are talking to various parts of the federal government, including the military,” said Annis, who declined to offer details about the talks. “We are seeking two things. First, we need direct financial assistance to run animal and human trials. Then, once we have data, we need expedited processing of EPA (Environmental Protection Agency) and FDA (Food and Drug Administration) applications.”
The company said both the decontaminant and the nasal sprays would be based on the company’s patented microbe-killing agent known as anti-microbial nanoemulsions.
Nanoemulsions are water and oil mixtures containing nano-sized droplets that kill anthrax spores, as well as a range of viruses, including HIV and herpes, and bacteria such as E. coli and salmonella. The droplets are 200 to 400 nanometers in size. A nanometer is a billionth of a meter.
The emulsion, which is described a milk-like substance, arose from military-funded research by Dr. James R. Baker Jr. at the University of Michigan. Because the emulsion is non-toxic and non-corrosive, the company said, it can be delivered in gels, creams or liquid products.
“If this is true, it is very impressive,” said Lou Chiodo, a pharmacologist at Texas Tech’s Institute of Environmental and Human Health in Lubbock, Texas. “The key is that it is non-toxic and non-corrosive. We can make corrosive decontaminants that kill anything, but you can’t use them on the body.”
In spray form, the anti-microbial nanoemulsion is applied to the mucosal membranes. There it remains, for a period of time measured in hours, the company said, to inactivate spores, viruses or bacteria that are breathed through the nose. The company said proteins belonging to the inactivated micro-organisms then spark an immune response.
According to the federal Centers for Disease Control and Prevention in Atlanta, inhaled anthrax is usually fatal if not treated with antibiotics quickly, before serious symptoms begin.
Nanobio said the U.S. military in December 2000 tested the nanoemulsion and confirmed its efficacy as a decontamination agent against an anthrax surrogate, B.globigii.
The company also said the Defense Threat Reduction Agency or DTRA demonstrated that the nanoemulsion works as a chemical decon agent.
“Right now the program is under review and is being compared to other technologies for possible use in DOD (Department of Defense) but determination has not been made yet,” said Capt. Bob Bennett, spokesman for DTRA.
“The bio-decon application is closer to implementation than the human protective (nasal spray) treatments,” Annis said. “The decon is used on skin clothing and surfaces so it requires EPA and FDA approval. The human protective treatment requires primate testing and human clinical trials for purposes of FDA approval.”
Annis said the company has no data on the nasal-spray treatment other than that it works on mice.
Despite that situation that only laboratory animals have been tested with the nasal spray, the company’s Web site includes a link where individuals can sign up to take part in human trials.
“They’re a long way off, but we wanted to take people’s names. When we run human trials, we obviously won’t test against real anthrax,” Annis said. “We’ll run them against a surrogate that might give you a cold or the flu. We would use the real stuff on primate tests, but that is extraordinarily expensive. And that’s why we need the government.”
“If it’s everything they say, it’s truly a wonderful thing to come along,” said Dr. Mohammad Akhter, executive director of American Public Health Association in Washington. “Of course there needs to be careful reviews by FDA so people can trust that it works.”
When asked if he thought the FDA should expedite nanoemulsion trials, Akhter said, “I think we are in extraordinary circumstances. I’d say let’s expedite this and go through a quick process to see about these claims.”
“Upon brief inspection, this appears to be a novel approach that looks very promising. I think research should go forward,” said Pamela Nagami, an infectious disease specialist at Kaiser Foundation Hospital in Los Angeles.
DXer said
December 16, 2003 Tuesday
Department of Defense Awards $3.2 Million Contract to NanoBio(R) Corporation
SECTION: FINANCIAL NEWS
LENGTH: 327 words
DATELINE: ANN ARBOR, Mich. Dec. 16
NanoBio Corporation (NanoBio) will use a $3.2 million contract by the U.S. Department of Defense (DOD) to support the development of antimicrobial nanoemulsions.
The award will help fund clinical trials to confirm the safety of these nanoemulsions for human topical use.
Applications of the nanoemulsion technology that are of interest to the DOD include the decontamination of in-fectious agents on humans and the prevention of infectious disease following a bio-terrorism attack.
“This contract validates the government’s interest and commitment to our technology,” stated Dr. James R. Baker, Jr., Chief Scientific Officer of NanoBio. “The DOD funded research leverages our Phase II clinical trials for the devel-opment of commercial applications of our technology.”
NanoBio already has in development pharmaceutical treatments for fungal, viral and bacterial infections of the skin and mucous membranes.
The first topical product, a treatment for cold sores (Herpes labialis) has been approved to begin phase II clinical trials in March of 2004. In addition, trials will begin in June for a topical treatment for nail fungus (onychomycosis). NanoBio’s products have important therapeutic, safety and cost advantages over currently available treatments.
Additional longer-term products in development include treatments for genital herpes, shingles, and a broad-spectrum vaginal infection treatment that is efficacious against fungal, bacterial and parasitic infections.
NanoBio Corporation is a biopharmaceutical company whose mission is to develop and commercialize topical and mucosal pharmaceuticals based on its patented antimicrobial nanoemulsion technology. The technology was developed at the University of Michigan Medical School. NanoBio, a privately held corporation, is the exclusive licensee of this technology.
DXer said
March 2, 2004 Tuesday
U.S. Environmental Protection Agency Awards NanoBio(R) Contract For Development of Anthrax Decontamination Product
SECTION: FINANCIAL NEWS
LENGTH: 493 words
DATELINE: ANN ARBOR, Mich. March 2
NanoBio(R) Corporation announced today that it has been awarded a $70,000, six-month contract from the U. S. Environmental Protection Agency (EPA). This Phase I award is from the EPA’s Small Business Innovation Research Program (SBIR) and will be used to optimize NanoBio’s environmental decontamination product, NanoProtect(TM). The SBIR program provides for an additional $225,000 that could be awarded to NanoBio based on results from these Phase I studies.
NanoProtect’s development plan will result in a safe bio-decontaminant that kills bacteria, viruses, spores and fungi while being uniquely non-toxic to humans or the environment. The EPA’s specific interest relates to their Safe Buildings Program where NanoProtect would be used by first responders in the event of a bio-attack or biohazard accident to decontaminate facilities and equipment. In addition to an excellent safety profile, it is expected that deployment costs will be significantly lower with NanoProtect as compared to currently available technologies.
John Coffey, NanoBio’s Vice President, Business Development states, “The award of this contract identifies the unique role NanoBio’s technology could play in the EPA’s Safe Buildings program. It provides an important focus for the development of this product and facilitates the introduction of NanoProtect to other government agencies to include the Department of Homeland Security.”
Company Background:
NanoBio Corporation is a biopharmaceutical company whose mission is to develop and commercialize topical and mucosal pharmaceuticals based on its patented antimicrobial nanoemulsion technology. The technology was developed at the University of Michigan Medical School. NanoBio, a privately held corporation, is the exclusive licensee of this technology. NanoBio has advanced its pharmaceuticals using $7.5 million obtained from sales revenue, investors, a Michigan Life Science Corridor (MLSC) grant, and a grant from the United States Department of Defense.
In addition to the NanoProtect bio-attack decontamination product, NanoBio is developing its proprietary NanoStat(TM) technology as a pharmaceutical to treat fungal, viral and bacterial infections of the skin and mucous membranes.
It is expected that the first NanoStat topical product, a treatment for cold sores (Herpes labialis) will begin phase II clinical trials in March of 2004. In addition, trials are expected to begin in July for a topical treatment for nail fungus (onychomycosis).
Additional longer-term products in development include treatments for genital herpes, shingles, and a broad-spectrum vaginal infection treatment that is efficacious against fungal, bacterial and parasitic infections. NanoBio’s products have important therapeutic, safety and cost advantages over currently available treatments.
DXer said
Crain’s Detroit Business
August 14, 2006
NanoBio investor has billion-dollar vision;
Perseus says it will wait for company to grow
BYLINE: Tom Henderson
SECTION: COVER STORY; Pg. 1
Norm Selby says his company’s $30 million investment last week in a small Ann Arbor-based spinoff from the University of Michigan – NanoBio Corp. – might seem impressive, but it pales when contrasted to his plans to grow the business.
“We see this as a billion-dollar company,” said Selby, a partner in Washington-based Perseus L.L.C., a private-equity firm that broke its own rules by investing in a small company with no sales and no product ready for market.
The investment was the second largest in the past 10 years for a state biotech company, according to records compiled by the Washington-based National Venture Capital Association, just behind the $31 million Ann Arbor-based QuatRx Pharmaceuticals Co. got in December 2004 to help develop therapies for cardiovascular, metabolic and endocrine diseases.
QuatRx’s venture-capital investors had planned for a relatively quick cash-out. They’d hoped to take the company public this year but QuatRx announced in July it was withdrawing its filing of an initial public offering because of a lack of interest in the market.
Selby said Perseus has no such short-term hopes for NanoBio, which has products in various stages of Food and Drug Administration-required testing. The first two products, to treat herpes labialis and nail fungus, could be on the market in 2009, according to John Coffey, NanoBio’s vice president for business development.
By 2012, the company hopes to market nasally administered vaccines and products to treat shingles, genital herpes and antibiotic-resistant bacteria.
“We like the area they are in, infections and bacteria,” Selby said. “Ten or 15 years ago, Big Pharma stopping doing research on anti-infectants and anti-bacterials. There are few products along those lines in the pharma pipeline.”
NanoBio’s CEO, Michael Nestor, said the investment will have a modest impact on hiring short-term – he plans to go from eight employees to 16 over the next year – but he said the company should be employing “in the hundreds” over the next few years.
Another selling point for Selby was the company’s intellectual property. According to Coffey, it has been granted four broad-based patents, has seven pending and will be filing for others.
Selby said that while a fairly long time to market for some products – 2012 or later – might have scared off venture capitalists in the past, it was of little concern to him.
“We’re not venture capitalists at all. We’re a classic private-equity firm,” Selby said. He said typically VC firms look for quicker exits than private-equity firms. He said Perseus, the same company that bought the Converse line of sneakers out of bankruptcy, returned it to profitability and then sold it to Nike for $305 million in 2003, is willing to put in the resources and take the time to grow NanoBio.
“Our clear game plan is to execute like hell the next few years and see where we go from there,” he said.
He said the importance of growing NanoBio to a value of $1 billion or more is to differentiate it from a large field of biotech companies.
“There are 500 public biotech companies with a capitalization of $200 million or so. It’s a no-man’s land. You can’t take a company public now, or get any liquidity if you’re that size. The equity markets don’t value them,” he said.
The ideal exit strategy, he said, is to grow NanoBio, develop its products, bring them to market and then sell the company to one of the large pharmaceuticals.
“But we’re in absolutely no hurry to do that,” he said.
Revenue doesn’t always have to be great to yield a high sales price. Pfizer Inc. paid $1.3 billion in 2004 for Ann Arbor-based Esperion Therapeutics Inc., based on the potential of a promising drug that reduces artery-clogging plaque.
Esperion was publicly traded, but was still in the research-and-development phase when it was bought.
NanoBio was founded in 1999 as a result of an experiment gone awry at what is now the University of Michigan Center for Biologic Nanotechnology. The center’s director and NanoBio’s founder, Dr. James Baker, was looking for a medium to deliver genetic material into bacteria.
He and his researchers came up with an emulsion of tiny droplets – each about 1/400th the width of the average human hair – made up of soybean oil and solvent and coated with a lubricant.
But instead of delivering the genetic material into the targeted bacteria, the emulsion exploded it on contact.
“It was salad dressing that kills,” Baker said.
The droplets were so slippery they wouldn’t bind with each other, but they would bind with the bacteria causing it to burst open to form a larger droplet. Tests showed similar results with a wide range of viruses, including HIV and influenza.
The data was so strong, Baker said, he decided to form a company based on the technology, known as nanoemulsions.
Since then, the company has existed largely on the basis of large federal grants, including one for $3.2 million from the Department of Defense and one of $11.8 by the U.S. Defense Advanced Research Projects Agency. It also has received about $9 million from angel investors, according to CFO Dave Peralta, and last July won a $6.3 million grant from the Gates Foundation to develop a nanoemulsion-based vaccine system that uses nasal swabs instead of shots for use in the Third World.
“The Gates Foundation funding was a very big third-party verification for us,” Selby said.”
But until last week, money from more organized investment sources such as venture capital companies or private equity companies was hard to come by. Coincidentally, Nestor said, the same time Perseus made its offer, NanoBio got an offer from an out-of-state venture-capital firm.
Mary Campbell, general partner of EDF Ventures, had heard of the offer from the venture-capital firm and was hoping to be part of a syndicate if one was put together. Generally an out-of-state VC firm will partner with a local company just to have more of a hands-on feel.
Early this year, Campbell said her firm tried to put a deal together to invest in NanoBio. “The exciting market opportunity to us was the treatment of toenail fungus. From the due diligence we did, there clearly was an unmet need that affects a lot of people,” she said.
“But we got caught up in some issues of our own that didn’t allow us to step forward and lead a syndicate. They needed more money to get things to clinical trials than we could afford to raise.”
DXer said
Richard C. Holbrooke – WhoRunsGov.com, a Wash Post Co
President George HW Bush once described Richard Holbrooke as “the most persistent … Holbrooke joined Perseus LLC, a private equity firm as vice chairman. …
http://www.whorunsgov.com › Profiles – Cached – Similar
Richard “the ego has landed” (source: Wash Po) Holbrooke, as I recall, is #3 at Department of State and in charge of Pakistan and Afghanistan. He came to head Perseus. My old law firm handled the transaction where Perseus gained a majority stake in NanBio. Mr. James Baker, the NanoBio stake holder and principal, is fond of the quote that if there are no lions and tigers in the jungles, the monkeys rule.
Then of course there is Bruce who was driven to suicide.
I say let the Department of Justice stand for justice, not obstruction of justice.
Hear me roar, James.
DXer said
The commentators who claim that 100 had access — rather than 350 — appear not to have the record nor even the Amerithrax Investigative Summary.
A summary of a March 31, 2005 interview of Bruce Ivins explains:
“Where the flask of RMR 1029 were kept. Since we had a lab (room 115) in Building 1412 at the time, and since the spores were intended for aerosols, it’s possible that at least one of the flasks was kept int he lab refrigerator in 115 or in the 1st floor coldroom (much less likely) for a certain amount of time. We were eventually – I think it was probably before 2001 – “moved out” of the area by Aerobiology, and at that point may have brought RMR 1029 material back to 1425. I honestly don’t remember, but it would make sense.”