CLEVELAND, Oct. 26 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. (NASDAQ:CBLI)(Boston Stock Exchange:CFB), announced today a letter to the Company's shareholders from its President and CEO, Michael Fonstein, Ph.D. The letter is included in its entirety below:

Dear Fellow Shareholder,

It has been just three months since Cleveland BioLabs Inc. (NASDAQ:CBLI) has become public and we are making great strides in our development. Several significant positive events occurred recently and others are expected in the near future. Although these events are beginning to be reflected in the rise of our stock, we believe they are not yet fully appreciated by the market and that our stock is significantly undervalued at today's price. We have undertaken an aggressive market communications strategy and retained investor relations counsel to aid in this effort.

    Over the last few months, CBLI achieved a number of important milestones:
     * We received FDA approval to start a Phase II trial of our Curaxin
       CBLC102 compound for advanced, refractory prostrate cancer;
     * We reported highly successful results for our non-human primate
       efficacy trial of Protectan CBLB502 for radiation protection
       (injected prior to exposure);
     * We received two phase II awards from NIH totaling $1,500,000
       (and fundable scores for three more) bringing the total number of
       grants we received from NIH, DOD and NASA to 14; and
     * We very recently achieved a breakthrough in our radiation protection
       program, demonstrating CBLB502's efficacy in mice after exposure to
       radiation and significantly expanding the market potential for this

Cleveland BioLabs' mission is to develop drugs, which treat cancer and protect us from radiation and other deadly diseases acting through similar molecular mechanisms. This development is based on our original research in the area of apoptosis (programmed cell death) and the discovery of a unique source of molecules modulating this process.

Apoptosis (programmed cell death) is a basic cellular defense mechanism, which responds to DNA damage and various other stresses and determines whether a damaged cell should be repaired, or killed. Through this mechanism, apoptosis prevents improperly repaired, or damaged cells from becoming cancerous, which means that cancerous cells need to block this mechanism in order to successfully develop. If we unblock this mechanism in a mature cancer cell, it will recognize the cancer signals and kill the cell. Conversely, external stresses, like radiation, induce apoptosis and at high doses kills too many potentially repairable cells, causing damage in critical tissues and death of an organism. In this case, delaying the apoptotic response and enabling cells to recover can drastically reduce radiation's negative impact on the organism.

CBLI's drugs act on both sides of this equation. Curaxins turn apoptosis on to kill cancer cells, and Protectans temporarily turn apoptosis off to protect against radiation or other stresses.

Our lead Curaxin, CBLC102, is an oral drug that demonstrated cancer- killing effects in vitro, in animal models, and in live tumors removed from patients and put in Petrie dishes. The FDA has approved a Phase II efficacy study at the Cleveland Clinic and Case Western Reserve University Hospital and enrollment will be starting momentarily for advanced, refractory prostrate cancer. Independent research has shown that nearly 90% of all cancers can be targeted by our drug candidate based on this mechanism of suppression of apoptosis.

Our lead Protectan, CBLB502, shows unprecedented protection against radiation when injected into mice prior to exposure. This has resulted in the survival of the animals after exposure to super-killing doses of up to 14 Gy of total body irradiation. CBLB502 can prevent both hematopoietic (HP) and gastro-intestinal (GI) acute radiation syndromes and is the first known substance that protects from the lethal GI syndrome.

CBLB502 also showed strong radioprotection in non-human primates, enabling survival of the majority of animals that received deadly doses of whole-body radiation. This drug is undergoing an accelerated development program under the FDA two-animal rule, which requires us to show efficacy in two animal species (including primates) and only safety in humans.

Based on our efficacy demonstrated in monkeys and our progress in developing GMP manufacturing, we believe that we are less then 24 months from submission of an NDA to the FDA. In addition, there is a possibility that we could receive commercial orders from the Department of Defense in an even shorter timeframe. CBLB502 is initially being developed as a radiation antidote for the military, first responders, nuclear plant workers and eventually for all people who would live near major nuclear fall out areas.

Very recently, we achieved a significant breakthrough in our radiation protection program. We demonstrated that CBLB502 is effective even after mice have been exposed to a near-lethal radiation doses up to 9Gy. This will significantly expand the drug's market potential, adding the ability to use it for the general population following radiation exposure.

Experiments with cancer-bearing mice have also established the potential for Protectan CBLB502 to be used as an adjuvant to radiation therapy for cancer treatment. Its use enables an increase in tolerable doses of radiation, with no protective effect on tumors, thus increasing the therapeutic effect of the treatment.

We are very excited about all of these advances and continue to leverage our strategic relationships with the Cleveland Clinic Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute to further our development. Our partnership with the Cleveland Clinic has given us access to state of the art facilities and world-accomplished researchers to help develop our compounds. In fact, the company has the exclusive right to all intellectual property developed by two major labs at the clinic in the area of cancer and tissue protection. In addition, ChemBridge has a library of more than 250,000 chemical compounds and is a powerful partner in drug development. The Armed Forces Research Radiobiology Institute has also been critical in progressing our Protectans as radiation protector candidates with the Department of Defense.

The Company has sufficient capital to proceed with our development strategy for the next 22 months and have a steady flow of grant funding from the NIH, DOD and NASA. We recently received two Phase II awards from NIH totaling $1.5 million and (and fundable scores for three more), bringing the total number of grants we have received to 14.

We have submitted 14 patent applications to protect our compounds and their applications and have confidence that they will be granted. It is our goal to build a strong intellectual property portfolio around the work we are doing to ensure secure returns for our investors.

We have the right team and partnerships in place to succeed and have taken every measure possible to minimize development risks.

    We believe CBLI will be successful because of our:
     * Proprietary technology platform;
     * Late-stage products with accelerated development pathways;
     * Extensive pipeline; and
     * Near-term value drivers.

We are committed to delivering shareholder value and appreciate your support.

    Michael Fonstein, Ph.D.
    President & CEO

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute. To learn more about Cleveland BioLabs Inc., please visit the company's website at

This press release contains forward-looking statements that reflect our current view with respect to various aspects of the events described above. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption "Risk Factors."

    The Global Consulting Group
    Rachel Levine
    T: (646) 284-9439