Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Last week, Cleveland Biolabs (NASDAQ:CBLI) announced that it had raised approximately $8.39 million in a registered direct offering with what termed "a single institutional investor." Apparently, the company agreed to sell 1,400,000 shares of its common stock at a discount price of $5.99 per share despite the fact that the stock was trading over $7 when the deal was announced.

Having a name like this take a position in the stock will bring credibility to the company and help call more attention to all the great things it has lined up for the weeks and months ahead, much less for the long term.

While it may not seem fair to the retail investors who have been paying over $7+ for shares of the stock at the time, we believe Michael S. Dell,will soon be revealed as that investor. As many on Wall Street know Dell has a strategy like Warren Buffett’s, and his investing philosophy and top holdings speak for themselves.

Our sources tell us that he went out of his way to reach out to CBLI personally and told them of his interest in the company. He wanted in and he wanted in as quickly as possible. Could it be that Dell is hearing the same things about additional government funding and orders set to start coming into the company for their FDA fast tracked anti-radiation countermeasure, CBLB502? Several analysts, think shares of the company could double or triple from current levels during Q1 of 2011. As I told readers when the shares were trading at $3 just months ago, CBLI is a multi-billion dollar company waiting to happen.

According to a recent article in Fortune magazine, Michael Dell’s personal investment is managed by MSD Capital. Since started in 1998, the firm's track record and achievements have taken them over the $12 billion mark for asset management while investing in public equity, special opportunities, private equity, real estate and partnerships.

According to the MSD website, "make long-term equity investments in a limited number of outstanding companies, both in the United States and abroad. We employ a disciplined, research-intensive analytic process in searching for businesses that possess sustainable long-term competitive advantages and are managed by honest, astute and shareholder-minded management teams. We firmly believe that businesses create wealth for their owners through the long-term generation of net free cash flow. Although we typically invest as a minority owner of publicly-traded companies, given the long-term perspective that we take when we make investments, we consider ourselves to be a partial owner of the businesses in which we invest. We focus on the absolute value of businesses, not their value relative to other "peer" companies or general stock market indices."

Dell founded Dell in 1984 and in 1992 became the youngest Chief Executive Officer of a company ever to earn a ranking on the Fortune 500. He is easily considered a visionary leader and has earned titles like “Entrepreneur of the Year” from Inc. magazine, “Man of the Year” by PC Magazine, “Top Chief Executive Officer in American Business” from Worth Magazine and “Chief Executive Officer of the Year” by Financial World and Industry Week magazines. The fact that he believes strongly enough in CBLI will speak volumes to the rest of the biotech industry.

Did the company, in essence, pay for that additional exposure and "credibility?" In a sense, yes. I think so. Will it be worth it? Definitely.

Pipe: http://www.cbiolabs.com/product.php

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

@b00n

CBLI interessiert mich von der Firma her.

Cleveland BioLabs, Inc. (Nasdaq: CBLI) announced that they have entered into a registered direct offering with an accredited institutional investor for the sale of up to 1.4 million shares at a price of $5.99 per share.

Warum pendelt der Kurs denn immer noch um die 7 herum?

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Why would the company agree to sell so many shares at $1 per share less than the rest of the market was willing to pay?"

"Why do they need to raise more money if they're about to start getting these big government orders from the U.S. and abroad?"

"More dillution?! You said the company wouldn't do this!"

Having a name like this take a position in the stock will bring credibility to the company and help call more attention to all the great things it has lined up for the weeks and months ahead, much less for the long term.

While it may not seem fair to the retail investors who have been paying over $7+ for shares of the stock at the time, we believe Michael S. Dell,will soon be revealed as that investor. As many on Wall Street know Dell has a strategy like Warren Buffett’s, and his investing philosophy and top holdings speak for themselves.

Our sources tell us that he went out of his way to reach out to CBLI personally and told them of his interest in the company. He wanted in and he wanted in as quickly as possible.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs to Raise Approximately $8.39 Million in Registered Direct Offering With Single Institutional Investor

Read the full report: http://biomedreports.com/2010122361780/cleveland-biolabs-to-raise-approx...$8.39-million-in-registered-direct-offering-with-single-institutional-investor.html#ixzz19iBhTtG2

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Danke b00n, was denkst du, fällt CBLI noch etwas oder bekommt die Aktie durch den neuen Investor und die PR durch BMR erst richtig Schub?

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cancer drug sales are slowing down in the U.S., Reuters reported Monday. According to pharmaceutical research firm IMS Health, U.S. sales of oncology drugs increased only 3.5 percent in the first nine months of 2010, compared to sales growth of 23 percent in 2006, 14 percent in 2007, and 9 percent in 2008 and 2009. The slowdown in sales growth is primarily being caused by price increases as well as the entry of new generics as older, established drugs lose patent protection. The article also noted that many recent drugs are simply variations of existing drugs that wind up jostling for space in an already crowded market.

The article notes that the oncology field will largely be driven by innovation. Those seeking the cancer innovators of tomorrow might take a look at the following companies:

Coronado Biosciences and Cleveland BioLabs (CBLI) are both developing drugs that target the process of apoptosis, or programmed cell death. Cleveland BioLabs recently dosed the first patient in a multicenter Phase Ib trial of curaxin in patients with liver tumors. The company was also awarded a $244,479 grant under the QTDP program.

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CBLB502

Cleveland BioLabs, Inc.'s CBLB502 Granted Orphan Drug Status From FDA

Tuesday, 30 Nov 2010 11:26am EST

Cleveland BioLabs, Inc. announced that CBLB502, a drug under development to treat exposure to radiation, has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Cleveland BioLabs, Inc. Receives Notice Of Patent Allowance From China For CBLB502

Tuesday, 19 Oct 2010 09:00am EDT

Cleveland BioLabs, Inc. announced that it has received a notice of grant of patent for CBLB502 from the State Intellectual Property Office of the People's Republic of China. Allowed claims cover the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502. CBLB502 is a bio engineered derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

Cleveland BioLabs, Inc. Secures Contract From United States Department Of Defense

Friday, 17 Sep 2010 07:00am EDT

Cleveland BioLabs, Inc. announced that it was awarded a $45 million contract (including options), from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile CBLB502 as a medical radiation countermeasure. Under the terms of the contract, the CBMS-MITS will initiate funding for Cleveland BioLabs' advanced development of CBLB502 through Food and Drug Administration (FDA) approval in the amount of $14.8 million (including options). Upon FDA licensure, the contract provides options for the purchase of $30,000,000 worth of CBLB502 troop equivalent doses.

Cleveland BioLabs, Inc.'s CBLB502 Receives Fast Track Status From U.S. Food And Drug Administration

Thursday, 22 Jul 2010 08:30am EDT

Cleveland BioLabs, Inc. announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

seit seehr, zu langem, auf watch, nun in, erste tranche 7.15 :oops:

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

As the company pointed out in their own press release, orphan drug status qualifies CBLB502 for an accelerated review process, tax credits, financial assistance for development costs, and seven years of marketing exclusivity upon approval by the FDA for this indication. The designation also allows for a possible exemption from the FDA-user fee and assistance in clinical trial protocol design.

Orphan drug designation program also provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 people but are not expected to recover the costs of developing and marketing the treatment.

"We are very excited that CBLB502 has been assigned orphan drug status for its lead indication and look forward to working closely with the FDA as we complete development," said Michael Fonstein, Ph.D., president and chief executive officer of Cleveland BioLabs.

In July 2010, CBLB502 was granted fast track status from the FDA for reducing the risk of death following total body irradiation during or after radiation disaster. There is currently no FDA approved medical countermeasure for this indication.

We continue to be very bullish on CBLI and agree with analysts that the stock has significant potential to start trading at multiples greater than the current trading levels within a relatively short period of time.

Aside from pending U.S. and foreign government orders, the company's entire pipeline and development portfolio with potential applications for oncology and cancer treatments points in the right direction and CBLI could easily become a multi-billion dollar company within the next 12-18 months.

CBLI shares saw a 52-week trading high of $7.24 in September when the Department of Defense selected the company's injectable compound, CBLB502, for a contract to protect troops during a nuclear catastrophe. That contract gave Cleveland $14.8 million in immediate funding to be used for completing more tests and the application process with the FDA.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Rein @6.85

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs, Inc. (NASDAQ: CBLI) Downgraded to a “Neutral” Rating

http://www.americanbankingnews.com/2011/01/07/cleveland-biolabs-inc-nasd...

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Bio-Defense Play Update

by M.E. Garza

January 10, 2010

I have an update on Cleveland Biolabs (Nasdaq:CBLI) that you may find interesting. Two weeks ago, after the company announced that they had takena substantial investment from "an individual investor" we got wind that it was Michael Dell and we were of the opinon that when that news became public, the markets would react. Looking at one of the company's most recent press releases, Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, is set to give a presentation today at the Sidoti Microcap Conference in New York City.

We hear on the street that the company is also taking meetings with big institutionals and funds while they are in New York.

Even more intriguing is the chatter that Cleveland Biolabs may be getting even more money from the U.S. Government than I had previsouly reported. Many of the company's proprietary discoveries regarding programmed cell death and treatments for cancer and protection of normal tissues from exposure to radiation and other stresses have been funded by big research dollars from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS).

We had been hearing that sometime before the end of the year, the agency would be awarding the company either a grant or some type of order totalling more than $50 million dollars. As these government contracts and awards always take longer than anticipated to work out its no surprise that nothing has been announced yet. What is surprising is that now we're hearing the monies will be for as much as $90 million- almost double.

Credible chatter has the award occuring some time in February so if you're an options player, it may be wise to look at some calls with a little wiggle room (just in case of another delay). Shares have been down a bit lately, although not much, and if company management starts to spread word about Dell's investment either at their presentation or during their roadshow meetings, we could see a nice appreciation in price prior to the anticipated news.

As I've written before. I've been long CBLI since the stock was at the $3 level and feel (as do other analysts) that share prices could triple or quadruple from current levels as multiple government orders start coming in within the next 6-12 months.

The company announced last summer that their radiation counter-measure, CBLB502 was granted Fast Track status from the FDA for reducing the risk of death following total body irradiation during or after a radiation disaster.

After more research, we will release this news to the rest of our readers sometime within the next 24-48 hours.

Disclosure: Long CBLI

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Presentation sheds light on significant upcoming developments for Cleveland Biolabs

by M.E. Garza

January 11, 2011

As we told our subscribers on Monday, Cleveland Biolabs (Nasdaq:CBLI) has confirmed some significant pending developments in regards to thier radiation counter-measure, CBLB502, which protects mammals from radiation using flagellin or its derivatives.

On Monday afternoon, Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, gave a presentation at the Sidoti Microcap Conference in New York City. He told attendees that a significant BARDA development contract for CBLB502 is being worked on. In addition to a number of other developments and milestones which are on-tap for the company during 2011, Fonstein said that his company is anticipating the publication of a buying request for proposal (RFP) from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) for a radiation-countermeasure.

The bullet-points, which were highlighted in a slide during the company's presentation line up perfectly with some of the rumors we have been hearing for the last couple of months. Cleveland Biolabs- who has been awarded millions by the U.S. government for helping to develop CBLB502- may be close to actually landing tens of millions of dollars in additional grant monies which should lead to a major U.S. government purchase.

That purchase would be followed by an order from the government of Israel- whose leadership and constituency have grown increasingly anxious given the development of Iran's nuclear programs and recent Wikileaks revelations that Iran has obtained North Korean missiles which can strike as far away as Europe. Company officials have been asked by some of these foreign governments not to speak about potential orders, but published reports in foreign newspapers clearly indicate Israel's interest in CBLI's radiation counter-measure.

We are told that management at CBLI has been approached by several other countries who have all, ubiquitously, expressed an interest in obtaining the same product for their own defense stockpiles. Since U.S. Government grants have played a significant role in developing the product, it stands to reason that the U.S. will be first in line and may even have some say about which countries would be allowed to come in behind them for the game-changing bio-defense drug.

A little over two weeks ago, after the company announced that they had taken a substantial investment from a mysterious "individual investor" we told our readers that Michael Dell is that buyer. No one from Dell's office, Cleveland Biolabs, the banks or legal firms involved in that transaction have contacted us to correct our report, so we continue to be of the opinon that when that news finally becomes public, the market will react. Dell's $14+ billion fund targets winners with Warren Buffet like accuracy and he reportedly went out of his way make sure his $8.39 million bet on CBLI was in place as soon as possible.

As we understand it, Fonstein will spend the rest of his time in New York City making presentations to institutional investors and hedge-funds. It is not unreasonable to assume that some of those groups will add significant buying pressure to the stock in the weeks ahead- particularly since it appears those the significant BARDA development could come into play as soon as February. Those developments had been expected to occur during Q4 2010, so in some respects they may be considered over-due.

We had been hearing that the agency could be awarding almost twice as much as we had previously reported. The $50 million dollar figure we kept hearing may actually end up being closer to $90 million. Confirmation of those rumors would easily rocket shares beyond analyst expectations for 2011.

We've been covering CBLI since the stock was below $3 and feel more strongly than ever that the company shows the markings of a multi-billion dollar company witing to happen. We anticipate share prices starting to rise significantly during Q1- especially given the number of other significant and forward looking news items that are listed in the 2011 milestones list.

CBLI announced last summer that their radiation counter-measure, CBLB502 was granted Fast Track status from the FDA for reducing the risk of death following total body irradiation during or after a radiation disaster.

Disclosure: Long CBLI

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

stimmt mich auch eher zuversichtlich betr. der weiteren entwicklung:

chart

http://i53.tinypic.com/21ag0g8.jpg

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Jan 20, 2011 09:37 ET

Cleveland BioLabs Announces Potential Direct Anticancer Effect of CBLB502

BUFFALO, NY--(Marketwire - January 20, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it has accumulated preclinical data demonstrating that CBLB502, a drug under development to treat exposure to radiation, has direct anticancer effect in several transplanted cancer models grown in mice and rats including colon and lung cancer, lymphoma and melanoma. In one of the animal models of transplanted colon cancer, CBLB502 treatment resulted in complete tumor regression with no recurrence of the disease in a large percentage of animals.

Experimental results suggest that CBLB502's anticancer effect stems from the same mechanism which underlies its ability to treat radiation exposure and which involves tissue-specific activation of innate immune response mediated by CBLB502's interaction with its receptor, TLR5. Antitumor effects largely depend on the expression of TLR5 by the tumor. However, in the case of tumors residing in the liver, the organ which has been identified as the natural primary target site for CBLB502 activity, tumors become effectively suppressed as a result of host immune system attack regardless of their TLR5 status. This characteristic makes liver metastasis a favorable target for potential anticancer applications of CBLB502.

Andrei Gudkov, Ph.D., D. Sc., Chief Scientific Officer of Cleveland BioLabs and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "We are very excited by these initial results, which extend CBLB502's potential medical applications in cancer treatment from use as a supportive care agent to reduce toxicities of radio and chemotherapy to use as a direct anticancer agent. We believe that clinical development of CBLB502's potential immunotherapy effects may be pursued in parallel to or in some cases as part of, our prior plan for supportive care applications, and we are currently modifying our development plan to integrate this important new opportunity. We expect to complete these adjustments shortly and move forward into the clinic."

William Cance, M.D., Surgeon-in-Chief and Chair of the Department of Surgical Oncology at Roswell Park Cancer Institute, stated, "I have always thought that CBLB502 had the potential to revolutionize several areas of clinical cancer treatment through its ability to protect normal tissues. With this recent demonstration of direct anticancer activity, I believe the potential for CBLB502 to achieve broad clinical application becomes even more likely. I am especially excited about the observations regarding CBLB502's effect on tumors in the liver, as this property could make a significant difference in a currently hopeless category of patients with advanced liver metastasis."

These findings were the result of research into the tissue specific activity of CBLB502, which was funded by a Grand Opportunities (GO) grant under the American Recovery and Reinvestment Act of 2009 from the Office of the Director and the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

This direction of research follows previous preclinical demonstrations of CBLB502's specific protection of normal tissues versus tumors, and its ability to protect such tissues in animal models of fractioned, localized radiation mimicking clinical regimens.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

neues jahreshoch Smile

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Close-Up: Cleveland BioLabs' Anti-Cancer Effect Excites Inve

Friday, 21 January 2011 11:50 garza

Shares of Cleveland Biolabs (Nasdaq:CBLI) continue to rise in dramatic fashion, one day after the company announced the potential direct anticancer effect of CBLB502.

Will the wonders of CBLB502 ever cease? Andrei Gudkov, Ph.D., D. Sci, the Chief Scientific Officer at Cleveland Biolabs appears to have stumbled upon a game-changing discovery involving his wonder drug.

Gudkov was doing experiments with radiation and chemotherapy on tumor bearing animals aimed at assessing the effect of CBLB502 on treatment side effects (supportive care/palliative). All the experiments had a control arm, in which animals received CBLB502 alone with no radiation or other drug. It was in this group that the scientific team at Cleveland first took notice of the anti-tumor effect of CBLB502 applied as a single agent.

“If the tumor expresses TLR5, it is induced by CBLB502 to attract the immune system,” explains Gudkov. “The organism interprets this situation as salmonella attack going through the tumor.”

As he reminds us, CBLB502 is re-engineered flagellin of salmonella, so the concept is elegantly simple: Once the cancer cells ingest 502, the immune system recognizes the growth as something that must be attacked. The once relatively invisible cells are seen as a threat by the body’s own defense mechanisms.

The implications here are also far reaching when one considers that the company and FDA already know so much about the safety and mechanism profiles of 502. In short, the company already knows so much about how the drug works in humans, that re-designing and adjusting their protocols to simultaneously test the anti-tumor effects as well as the palliative care effects may not only be possible, but also help bring the drug to market more quickly than anyone ever imagined.

“One can test both if the subject is not immunosuppressed,” explains Gudkov. “Otherwise the direct anti-tumor effect would not be visible. Tumors irradiated locally without immunosuppressive chemotherapy, such as those seen in head and neck cancer treatment, offer such an opportunity.”

At the very least, scientists believe that even if tumors are not eliminated, they could be delayed in growth. In fact, 502 shows innate immune attacks within hours by immune cell infiltration. The follow on effect of the drug may require activation of adaptive immune response, which Gudov thinks could take up to two weeks.

One assumption that will need to be confirmed experimentally is whether once the body has recognized the tumor that it will continue to fight the regrowth of those cells. Gudov and his team have some publications under review by peers and/or in the advanced stage of preparation for other discoveries. Investors can also rest assured that the company has filed extensive patents; otherwise they would not be openly discussing the discoveries.

“It is noteworthy that there were previously published observations about TLR5 agonist flagellin- a precursor of CBLB502, having anti-tumor effect in animal models,” says Godov. “Our studies provide the pharmacological agent usable in humans and the rationale for choosing tumors for such treatment. “

Make no mistake, if the drug can be proven to do what has been observed in animal models, it has the potential to change the immunotherapy landscape that so many biotech investors are excited about.

After all, what Cleveland is proposing here is an off-the-shelf drug that does not have to be tailored. It does not involve the timely and expensive re-programming of the body’s dendritic cells and perhaps because of those factors, the potential cost of treatment would not be as prohibitive as some of the existing immunotherapy drugs which are on the way to market now.

This is the same drug candidate that the company has fast tracked through the FDA as a countermeasure against acute radiation injury. The company doesn’t have to get validation for manufacturing. They don’t have to file a new IND and they don’t have to do a Phase I safety study. Instead, if they so choose, they get to move directly into Phase II with 502 as an anti-cancer play.

Remember also that this is the same drug that candidate that the government has spent millions developing as a nuclear attack counter-measure thus far. We continue to hear chatter about additional grants- increasing in value- which may be announced in the very near term. And, we fully anticipate that the drug will be approved by the FDA for its current indication, thereby setting the stage for substantial profitability as requests for purchase begin to roll in from not only the U.S. but foreign governments as well.

What’s not to like here? As I've been telling our readers for months, this is a winner through and through.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

b00n wrote:

Jan 20, 2011 09:37 ET

Cleveland BioLabs Announces Potential Direct Anticancer Effect of CBLB502

BUFFALO, NY--(Marketwire - January 20, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it has accumulated preclinical data demonstrating that CBLB502, a drug under development to treat exposure to radiation, has direct anticancer effect in several transplanted cancer models grown in mice and rats including colon and lung cancer, lymphoma and melanoma. In one of the animal models of transplanted colon cancer, CBLB502 treatment resulted in complete tumor regression with no recurrence of the disease in a large percentage of animals.

Experimental results suggest that CBLB502's anticancer effect stems from the same mechanism which underlies its ability to treat radiation exposure and which involves tissue-specific activation of innate immune response mediated by CBLB502's interaction with its receptor, TLR5. Antitumor effects largely depend on the expression of TLR5 by the tumor. However, in the case of tumors residing in the liver, the organ which has been identified as the natural primary target site for CBLB502 activity, tumors become effectively suppressed as a result of host immune system attack regardless of their TLR5 status. This characteristic makes liver metastasis a favorable target for potential anticancer applications of CBLB502.

Andrei Gudkov, Ph.D., D. Sc., Chief Scientific Officer of Cleveland BioLabs and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "We are very excited by these initial results, which extend CBLB502's potential medical applications in cancer treatment from use as a supportive care agent to reduce toxicities of radio and chemotherapy to use as a direct anticancer agent. We believe that clinical development of CBLB502's potential immunotherapy effects may be pursued in parallel to or in some cases as part of, our prior plan for supportive care applications, and we are currently modifying our development plan to integrate this important new opportunity. We expect to complete these adjustments shortly and move forward into the clinic."

William Cance, M.D., Surgeon-in-Chief and Chair of the Department of Surgical Oncology at Roswell Park Cancer Institute, stated, "I have always thought that CBLB502 had the potential to revolutionize several areas of clinical cancer treatment through its ability to protect normal tissues. With this recent demonstration of direct anticancer activity, I believe the potential for CBLB502 to achieve broad clinical application becomes even more likely. I am especially excited about the observations regarding CBLB502's effect on tumors in the liver, as this property could make a significant difference in a currently hopeless category of patients with advanced liver metastasis."

These findings were the result of research into the tissue specific activity of CBLB502, which was funded by a Grand Opportunities (GO) grant under the American Recovery and Reinvestment Act of 2009 from the Office of the Director and the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

This direction of research follows previous preclinical demonstrations of CBLB502's specific protection of normal tissues versus tumors, and its ability to protect such tissues in animal models of fractioned, localized radiation mimicking clinical regimens.

hab mir noch gedacht dass das ein willkommener "side-effect" ist

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Jan 25, 2011 09:00 ET

Cleveland BioLabs Receives $1.6 Million Development Contract From Defense Threat Reduction Agency of Department of Defense for CBLB502

http://www.marketwire.com/press-release/Cleveland-BioLabs-Receives-16-Mi...

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@b00n

Wir sind nun so ziemlich genau an der 100 MA. Ob wir wohl noch die $5.99 testen?

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

vlt sogar noch ein klein wenig tiefer. bin mir allerdings nicht sicher

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland Biolabs (NASDAQ: CBLI) set for significant capital appreciation

Tuesday, 01 February 2011

On January 20, 2011 Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced that they had accumulated preclinical data demonstrating that CBLB502, a drug under development to treat exposure to radiation poisoning from nuclear or radiological weapons or from a nuclear accident, has direct anticancer effect in several cancer models including colon and lung cancer, lymphoma and melanoma.

The company shared some very exciting preclinical data in the recent press release. They stated that CBLB502 had shown potential to suppress tumors. In one animal model, it was said that CBLB502 led to complete regression of tumors with little –to-no recurrence.

CBLI also stated that they will be looking at starting Phase I/II trials in cancer patients this year to look at both this new anticancer ability, and the previously discussed potential to offset the horrible side effects of radio and chemotherapy.

For those of you who follow developments in the $50 billion cancer market, both of these potential indications represent huge market dollars, if safety and trends of efficacy are seen in some of these trials.

The company’s first potential line to revenues is still the defense application, however, and we remain bullish on upcoming developments there as well. For example, CBLI has been working with the BARDA (Biomedical Advanced Research and Development Authority) of the Department of Health and Human Services on a potentially significant additional grant to fund remaining development of CBLB502 through and past FDA approval.

Five Reasons to Buy:

1. Potential Direct Anticancer Effect of CBLB502

2. CBLI already received its first conditional purchase order for CBLB502 from the Department of Defense back in September and is moving steadily towards submission for FDA licensure with both fast track and orphan drug status.

3. Expected news on BARDA publishing a formal Request for Proposal or RFP for buying of doses of radiation countermeasures for the national stockpile to protect civilians in this country. If you all recall, BARDA is the agency that has been spending hundreds of millions of dollars on these countermeasures over the past few years.

4. The recent infusion of capital from a single institutional investor, which we believe to be Michael Dell.

5. CBLI is well positioned to continue its climb in valuation.

We are reiterating our strong buy for Cleveland BioLabs based on expected near term drivers in the defense business with more development money from BARDA and hopefully a request for buying of doses.

We also believe that the start of medical trials for CBLB502 in cancer patients will bring a lot more attention from more traditional biotech investors and push the stock to significantly higher levels.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Another analyst thinks Cleveland Biolabs (Nasdaq:CBLI) is headed higher. The stock has been initiated with an Outperform rating and a target price of $10 by Wedbush.

Close-Up: Cleveland BioLabs' Anti-Cancer Effect Excites Investors

Presentation sheds light on significant upcoming developments for Cleveland Biolabs

Wedbush Securities is one of the largest securities firms and investment banks in the nation. The firm notes the company is developing CBLB502, an injectable protein, as a treatment for Acute Radiation Syndrome and as a radio-protectant in radiation oncology.

It further notes that human studies have shown CBLB502 to be safe in a Phase I/II study; animal studies have demonstrated protection against ARS.

The estimates for the total market for CBLB502 is $300 million in annual revenues, taking into account military, civilian and likely foreign demand. Wedbush expects that the company will be awarded a contract to supply the US government with CBLB502 to prevent ARS in the event of a radiological event.

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upcoming news event..

Cleveland BioLabs Inc.(NASDAQ: CBLI) looks primed to hear news about a government grant related to their CBLB502 program. In just the past few weeks, the US Biomedical Advanced Research and Development Authority (BARDA) has filled several contracts that had been expected for sometime. It appears that BARDA-HHS is finally making it’s way through their backlog of applications and getting funding out there. In CBLI’s recent presentation at BIO CEO, management noted that they expect a grant from BARDA-HHS to be over $50 million. We think that more financial commitment from the US government could eventually lead to foreign development contracts with countries like Israel. This grant also sets them up for a potential buying Request for Proposal(RFP) from BARDA for a radiation countermeasure later this year. Of companies competing for these contracts, CBLI is by far the most advanced program in this field, in terms of their lead drug and time to market. Their treatment protects 2 important body systems, the blood and gastrointestinal(GI) tract, that are crucial to improving survival in ARS. All of this additional funding will help CBLI further support CBLB502 thru development in acute-radiation syndrome(ARS) to eventual FDA approval and stockpiling.

Another benefit of CBLB502 is the reduced regulatory pathway due to the Animal Efficacy Rule, which is applied to drugs where the efficacy cannot be directly tested in humans due to ethical reasons. This allows them to bypass large Phase 3 studies, by demonstrating safety in humans and efficacy in 2 animal models along with GMP validation(related to manufacturing). They will be meeting later this year with the FDA to plan out their definitive safety study in humans and complete their pivotal animal effifacy study in primates. The expectation is that these studies, in conjunction with scaling up manufacturing, could lead to a BLA filing with the FDA in early 2012. They are also exploring CBLB502’s role as supportive therapy for cancer patients that have recently received total body irradiation. Their pipeline is also full of potential with CBLB612, as a stem cell inducing agent, which one could see as a competitor to Amgen’s billion dollar drug, Neupogen. They have adequate funding for 2011 and beyond; we expect additional government support to provide more financial stability.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

News of possible nuke reactor meltdown has people buying $CBLI. They should be buying for upcoming BARDA money grant too.

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Re: CBLB502

b00n wrote:

Cleveland BioLabs, Inc.'s CBLB502 Granted Orphan Drug Status From FDA

Tuesday, 30 Nov 2010 11:26am EST

Cleveland BioLabs, Inc. announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.

ich gehe von äusserst guter performance ab montag aus

beachtet auch was am freitag geschehen ist als die unsagbar tragische fukushima sache kam..

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Schade, ich habe das nicht geschnallt am Freitag. Habe noch die Shares bei meinem Einstieg zu 6.85. Werde heute bei den Dips dabei sein.

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sharewatch wrote:

Schade, ich habe das nicht geschnallt am Freitag. Habe noch die Shares bei meinem Einstieg zu 6.85. Werde heute bei den Dips dabei sein.

jup.. werd wahrscheinlich, auch ausbauen.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Incredibly, the short interest at CBLI has been growing since late August and is near the all-time high. If we are correct and the stock continues to push higher, the shorts will be squeezed and forced to cover.

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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

If we had to bet on one stock set to get play due to thie terrible news it has to be Cleveland Biolabs (NASDAQ:CBLI). On Friday, as the news of the potential meltdowns began to spread, traders began to scoop up shares of the company whose late-stage, FDA fast-tracked drug dandidate, CBLB502 was born for precisely this type of scenario.

It's a story that I know extremely well.

Just a couple of weeks ago, during BIO CEO in New York City, I spoke to CBLI's CEO, Michael Fonstein, specifically about the drug, on camera, as part of television special that will air nationally once additional photography and post-production are completed. While I am contractually prohibited from speaking or publishing too much about the project, I can tell you that news magazine is described by producers as "60 minutes meets Wired Magazine" and will feature a 12-15 minute segment about the history and journey of the ground-breaking technology which was invented by Cleveland BioLabs’s Chief Scientific Officer, Andrei Gudkov, Ph.D., D. Sci. while he was leading a broad research program focused on virology and cancer drug resistance in Moscow.

It was fascinating to learn that Gudkov's idea of creating a drug to protect humans from acute stresses such as radiation, or nuclear contamination exposure was born while he watched the infamous Chernobyl Nuclear Power Station Disaster unfold. The scientist was forever impacted by the deaths of the heroic firefighters who had climbed to the roof of the burning power plant to extinguish the fires. Fifty units responded to the fire and while they were successful in extinguishing all but the fire in the reactor, they were not wearing appropriate protective clothing.

"One by one they began to experience pressure in the chest, severe coughing, nausea, vomiting, and fainting," writes Grigori Medvedev in his book, The Truth About Chernobyl. "At first they thought it was from the smoke and heat of the fire. They were unaware that they had been walking on radioactive material that was emitting 20,000 roentgens per hour. Doctors found the fire fighters extremely agitated and nervous- suffering from "nuclear frenzy of the nervous system." They had extinguished the fires, but they were burned, many fatally, by the invisible flame of gamma and neutron radiation"

Not long after the fall of the Soviet Union, Gudkov moved to the U.S. and reestablished his lab at the University of Illinois at Chicago where he became a tenured faculty member in the Department of Molecular Genetics. It was that initial impact that led Gudkov and the team at Cleveland Biolabs to be prepared for a disastrous moment precisely like the one we are seeing play out in Japan.

CBLI’s unique approach of pharmacological modulation of apoptosis (programmed cell death) is ideally suited to address the need for effective radiation countermeasures and we would not be surprised to see the company take steps to get doses of their late-stage drug candidate to victims who may need it.

Whether or not a full meltdown can be averted is only part of the equation here. At best, full containment and clean-up efforts will take time and could see more workers and emergency personnel exposed to high levels of radiation. Sadly, the risk still exists for radiation to spread and affect hundreds or thousands in the areas around the power plants as well.

Speculators on Wall Street appeared to sense that too. On Friday we watched option calls of CBLI trade at 5x the average volume and prices jump from $6.80 to $7.19 before closing even higher- at $7.59- after hours.

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