- February – PNAS published studies elucidating immunotherapeutic mechanisms through which entolimod suppresses metastasis in cancer
- February – Started dosing Phase 2 trial with entolimod in patients with colorectal cancer in Russian Federation
- January – Started dosing Phase 2 trial of CBLB612 in patients with breast cancer receiving chemotherapy in Russian Federation
- January – Granted orphan drug status from EMA for entolimod as a medical radiation countermeasure
- September – Received two development contracts from the Department of Defense for advanced development of entolimod as a medical radiation countermeasure
- July – Reported phase 1 trial results for CBLB612 in Russian Federation
- June – Submitted pre-EUA dossier for entolimod as a medical radiation countermeasure to FDA
- June – Reported phase 1 trial results for entolimod in advanced cancer patients at ASCO
- April – Sold equity stake in Incuron, LLC joint venture
- April – Received Department of Defense breast cancer research program breakthrough grant for entolimod
- March – Completed dosing in Phase 1 study of CBLB612 in Russian Federation
- January – Executed reverse stock split
- December – Dosed first cancer patient with entolimod in Russian Federation
- October – Opened IND for entolimod in the Russian Federation
- October – Dosed first healthy subject with CBLB612 in Russian Federation
- September – Achieved agreement with FDA that existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-Emergency Use Authorization (pre-EUA) submission for entolimod’s biodefense indication
- September – Completed enrollment of Phase 1 advanced cancer trial with entolimod at Roswell Park Cancer Institute
- August – Opened IND for CBLB612 in the Russian Federation
- April – Reported Phase 1 trial for CBL0102 (predecessor to CBL0137)
- December – Completed dosing of CBL0102 Phase 1 trial in Russian Federation
- August – Dosed first cancer patient with i.v. CBL0137
- August – Filed IND for CBLB612 in the Russian Federation
- July – Completed GLP non-irradiated NHP study with entolimod (CBLB502)
- March – Opened IND for i.v. CBL0137 in the United States
- October – Dosed first cancer patient with oral CBL0137
- June – Announced Strong Survival Results for first GLP NHP study with entolimod (CBLB502)
- March – Dosed first advanced cancer patient with entolimod (CBLB502)
- April – Opened IND for oral CBL0137 in the Russian Federation
- October – Opened IND for entolimod oncology studies in the United States
- September – Launched Panacela Labs, Inc.
- August – Science Translational Medicine published breakthrough paper on mechanisms of action of Curaxins
- November – Dosed first advanced cancer patient with CBL0102 in Russian Federation
- November – Granted Orphan Drug status designation by FDA for entolimod (CBLB502)
- September – Received second major development and conditional purchase contract for entolimod (CBLB502) from CBMS/DoD
- July – Granted Fast Track status designation by FDA for entolimod (CBLB502)
- April – Launched Incuron, LLC
- January – Received first European patent for entolimod (CBLB502)
- January – Received first U.S. patent for entolimod (CBLB502)
- November – Entered licensing agreement for CBLB612 with Zhejiang Hisun Pharmaceutical Co. Ltd. In China
- September – Awarded prestigious Grand Opportunities grant from NIAID/NIH
- December – Completed first Phase II study of CBL0102 in Hormone Refractory Cancer Patients
- October – Dosed first healthy volunteer in initial safety study with entolimod (CBLB502)
- September – Awarded first major development contract for entolimod (CBLB502) from BARDA/DHHS
- August – Opened IND for entolimod’s (CBLB502) biodefense indication
- April – Science magazine published breakthrough paper on entolimod (CBLB502)’s radioprotective activity
- March – Awarded first major development contract for entolimod (CBLB502) from CBMS/DoD
- November – Completed first cGMP manufacturing run for entolimod (CBLB502)
- June – Formed strategic alliance with Roswell Park Cancer Institute and relocated to Buffalo, NY
- June – IPO on NASDAQ
- May – Opened IND for CBL0102 in US
- 2004-2006 – Received significant Small Business Innovation Research grant and contract funding from NASA and NIH
- August – Established Cooperative Research and Development Agreement with Armed Forces Radiobiology Research Institute
- June – CBLI founded in partnership with Cleveland Clinic
Cleveland BioLabs, Inc.
73 High Street
Buffalo, NY 14203
Permission to Use
Intellectual Property Rights
Certain Site Content
Any health or medical information included on the Site is for informational purposes only and is not, and is not intended to be, a medical diagnosis or a replacement for advice given by a physician or other healthcare professional, and none of the information included on the Site constitutes, or is intended to constitute, investment advice. Product candidates in development described on the Site have not been found safe or effective by any regulatory agency and are not approved for any use other than in certain clinical trials. Information included on the Site regarding any product approved for marketing is qualified in its entirety by reference to the full prescribing information for such product.
The Site may include certain third-party information or content. This third-party information or content does not represent the views, opinions or beliefs of Cleveland BioLabs, and Cleveland BioLabs disclaims any responsibility for any such third-party information or content.
This Site contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.
These factors include, among others, the Company’s history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company’s need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company’s R&D grants and contracts and its ability to win additional funding under such grants and contracts; the Company’s failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company’s inability to obtain regulatory approval in a timely manner or at all; the Company’s collaborative relationships and the financial risks related thereto; the Company’s ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company’s ability to comply with various safety, environmental and other governmental regulations. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the “Risk Factors” and “Forward-Looking Statements” described in the Company’s periodic filings with the Securities and Exchange Commission.
You may use the Site to contact Cleveland BioLabs with inquiries about information included on the Site. When you provide any information to Cleveland BioLabs, you agree to provide true, accurate, complete and current information and not to use a false or misleading name or a name that you are not authorized to use. You shall not transmit information to or through the Site that: (i) infringes or violates any intellectual property right or privacy right of any third party; or (ii) contains confidential information or trade secrets belonging to you or any third party. Cleveland BioLabs does not want to receive any such information. Any ideas, suggestions, information, know-how, material or other content transmitted to or through the Site will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, nonexclusive right and license for Cleveland BioLabs to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display, (in whole or part), or act thereon without any approval or consideration from you, in any form, medium, or technology now known or later developed for the full term of any rights that may exist therein. Cleveland BioLabs makes no promise, express or implied, that it will not use any such idea, suggestion, information, know-how, material or other content for its own purposes, which may include reproduction, publication, broadcast and posting.
The Site may provide hypertext links to other web sites that are not owned or controlled by Cleveland BioLabs. These links are provided for your convenience only. These web sites are controlled by third parties that Cleveland BioLabs does not control. Accordingly, Cleveland BioLabs expressly disclaims any responsibility for the content of such web sites, for the accuracy or reliability of the information thereon and for the quality of products or services provided thereby or advertised thereon. No link included on the Site constitutes an endorsement of Cleveland BioLabs of any content of, information on or product or service provided by, or advertised on, any such web site. If you choose to hyperlink to another web site, you do so at your own risk. Cleveland BioLabs reserves the right to terminate any hypertext link without notice.
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Compliance with Laws
You may use the Site only for lawful purposes. You agree that you will, at all times, comply with all applicable local, state, national and international laws, statutes, rules, regulations, ordinances and the like applicable to your use of the Site.
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Cleveland BioLabs does not warrant that the Site will be uninterrupted, secure or error-free, that defects will be corrected, or that the Site or the server that makes it available are or will be free of viruses or other harmful components. Information included on the Site may be incomplete, outdated or inaccurate and may contain typographical errors. Cleveland BioLabs makes no commitment to update the information included on the Site. YOUR USE OF THE SITE IS AT YOUR OWN RISK. UNDER NO CIRCUMSTANCES SHALL CLEVELAND BIOLABS OR ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS, REVENUE OR PROFITS AND THE LIKE) ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF THE SITE OR YOUR RELIANCE ON ANY INFORMATION CONTAINED ON THE SITE, WHETHER BASED ON CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR ANY OTHER BASIS, EVEN IF CLEVELAND BIOLABS HAS BEEN ADVISED OF, OR SHOULD HAVE KNOWN OF, THE POSSIBILITY OF SUCH DAMAGES. Because some jurisdictions do not permit the exclusion of certain warranties or the limitation of liability as set forth above, such exclusions and limitations may not apply to you.
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Collection of Personal Information
We collect Personal Information that you submit to us voluntarily through our website. The types of Information we collect are:
For visitors who email us directly via an email hyperlink:
- Email address
- Any content included in the email
For all visitors:
- As you navigate our website, certain passive information will also be collected, including Internet Protocol addresses, cookies and navigational data. This type of information will be used for the purposes of gathering data to provide improved administration of our website, and to improve the quality of your experience when interacting with our website.
Use of Personal Information
In general, Personal Information you submit to us is used either to respond to requests that you make, or to aid us in serving you better.
Disclosure of Personal Information
We do not sell your Personal Information or share your information with other companies or organizations without your consent. The content of any communications you send to us is non-confidential, and we are under no obligation to refrain from reproducing, publishing, or otherwise using such content in any way or for any purpose. We will not reproduce, publish, or otherwise use your Personal Information in connection with such content. We may, however, reproduce or use your Personal Information in connection with any resume you submit to us for employment recruiting purposes. We are free to use the content of any such communications (excluding any resume you submit to us), including any ideas, inventions, concepts, techniques, or know-how disclosed therein, for any purpose including developing, manufacturing, and/or marketing goods or services.
Our website is not designed for children under the age of 13. We will not deliberately gather Personal Information about visitors in this age group, and do not collect any information on this website with respect to age.
Links to Other Sites
Cleveland BioLabs, Inc.
73 High St.
Buffalo, NY 14203
This policy was last updated on June 15, 2012.