Navigation Links
Advanced Life Sciences Submits Full Proposal to NIAID for Development of Intravenous Formulation of Restanza as a Biodefense Countermeasure

CHICAGO, Nov. 9, 2010 /PRNewswire/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has submitted a full proposal to the National Institute of Allergy and Infectious Diseases (NIAID) under BAA-NIAID-DMID-NIHAI2010097 Development Of Therapeutics For Biodefense.  It is anticipated that one or more awards will be made from this solicitation and that the awards will be made on or about July 29, 2011.



"We are pleased to have submitted a full proposal to NIAID which, if awarded, could significantly advance the development of the intravenous (IV) formulation of Restanza™ (cethromycin) for the therapeutic treatment of bioterror pathogens as well as for the commercial indication of community acquired bacterial pneumonia," stated Michael T. Flavin, Ph.D., chief executive officer of Advanced Life Sciences.  "In addition to the efficacy demonstrated by the oral form of Restanza for post-exposure prophylaxis of anthrax, plague and tularemia, the oral form of Restanza has also shown initial efficacy in treating anthrax infection where symptoms are present.  This is significant because there are currently no agents approved by the FDA for the therapeutic treatment of anthrax, plague or tularemia and we believe that the increased bioavailability of the IV formulation of Restanza offers a promising option as a therapeutic treatment for these infections."

The Company's proposal requests $38 million over 5 years for the development of an IV formulation of its novel antibiotic, Restanza to therapeutically treat anthrax, tularemia and plague.  In addition, the proposal includes pre-clinical development as well as funding for four Phase 1 clinical trials and a Phase 2 clinical trial to evaluate the safety and efficacy of IV Restanza in patients hospitalized with moderate-to-severe community acquired bacterial pneumonia (CABP).

The Company recently announced positive results from preclinical toxicology and pharmacokinetic studies of an IV formulation of Restanza.  Restanza was administered intravenously as a single dose up to 60 mg/kg/day.  Results from this GLP study show that the IV formulation of Restanza was well tolerated and generated 10-fold greater plasma exposure compared to oral administration.  

About Restanza

Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of adults with mild-to-moderate community-acquired bacterial pneumonia ("CABP") and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at or follow us on twitter at

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements represent our management's judgment regarding future events.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.  Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Advanced Life Sciences Awarded U.S. Department of Defense Biodefense Contract Valued at up to $3.8 Million
2. Advanced Life Sciences Announces Second Quarter 2008 Financial Results
3. LUMEDX Introduces Advanced Multi-Modality, Multi-Vendor, Web-Enabled ECG Management Solution
4. Waters Brings Advanced Laboratory Data Management to Microsofts BioIT Alliance
5. Orange Coast Urology Offers Advanced In-Office Patient EVOLVE(R) Laser Prostate Treatment
6. Advanced Pest Control Earns Quality Pro Designation for General Pest Control Services
7. Independent Monitoring Board Recommends Completion of Accrual to Genasense(R) Phase 3 AGENDA Trial in Advanced Melanoma
8. Advanced Chemical Transport Opens Merced Facility
9. Advanced Life Sciences to Host Conference Call to Update Investors on Progress of Corporate Initiatives on October 1, 2008
10. Advanced Instruments Acquires D & F Control Systems Inc.
11. DuPont Meeting Significant 2008 Milestones in Progressing Advanced Biofuels
Post Your Comments:
(Date:11/30/2015)... 30, 2015  AbbVie, is introducing Good Morning ... a daily routine for managing the life-long condition of ... affect the way the body absorbs it so resources ... daily routine are important. The goal of the new ... manage their hypothyroidism by establishing a daily routine, spirit ...
(Date:11/30/2015)... HACKENSACK, N.J. and PETACH TIKVAH, Israel ... Inc. (NASDAQ: BCLI ), a leading developer of ... its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded ... Office of the Chief Scientist (OCS). This grant, ... to Brainstorm for 2015 activities to approximately $1.8 million (approximately ...
(Date:11/27/2015)... , November 27, 2015 ... Growing popularity of companion diagnostics is ... cancer biomarkers market with pharmaceutical companies and ... companion diagnostic tests. . ... Complete report on global cancer biomarkers ...
(Date:11/25/2015)... Md. , Nov. 25, 2015  PharmAthene, Inc. ... Directors has adopted a stockholder rights plan (Rights Plan) ... net operating loss carryforwards (NOLs) under Section 382 of ... --> PharmAthene,s use of its NOLs ... "ownership change" as defined in Section 382 of the ...
Breaking Biology Technology:
(Date:11/19/2015)... 19, 2015  Based on its in-depth analysis of ... BIO-key with the 2015 Global Frost & Sullivan Award ... Sullivan presents this award to the company that has ... needs of the market it serves. The award recognizes ... expands on customer base demands, the overall impact it ...
(Date:11/18/2015)... , Nov. 18, 2015  As new scientific ... children, doctors and other healthcare providers face challenges in ... families and patients. In addition, as more children continue ... a patient,s adulthood and old age. John ... The Children,s Hospital of Philadelphia (CHOP) . ...
(Date:11/17/2015)... , November 17, 2015 Paris ... 2015.   --> Paris from 17 ... DERMALOG, the biometrics innovation leader, has invented the first ... fingerprints on the same scanning surface. Until now two different ... Now one scanner can capture both on the same ...
Breaking Biology News(10 mins):