Navigation Links
Advanced Life Sciences' Restanza Demonstrates Efficacy in Treating Anthrax Infection

CHICAGO, Aug. 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive results from an animal study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) that was conducted to measure Restanza's therapeutic efficacy in treating inhalation anthrax after symptoms of infection had developed. The results of the placebo-controlled non-human primate study showed that a 14-day course of Restanza achieved up to a 60% survival rate when administered after animals demonstrated clinical symptoms of anthrax infection as a result of an inhaled dose of aerosolized anthrax spores that was 200 times the median lethal dose of anthrax. None of the animals that received placebo survived. Due to the extreme lethality of anthrax infection once symptoms appear, Restanza's ability to achieve a 60% survival rate is clinically and statistically significant. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), which is a component of the Department of Health and Human Services (HHS), an agency of the U.S. Government.


Today, there are no approved antibiotics for therapeutic treatment of anthrax infection, and the only approved drugs are administered for post-exposure prophylaxis before the onset of symptoms. In the event of an inhalation anthrax attack, victims may not be aware that they are infected with anthrax until symptoms of anthrax are present. The initial clinical signs and symptoms are nonspecific and may include malaise, headache, fever, nausea, and vomiting and are followed by a sudden onset of respiratory distress and chest pain. The onset of respiratory distress is followed by shock and death, with close to 100% mortality.

The results of this pivotal study complement previously reported efficacy results from two non-human primate studies showing that Restanza is highly effective in protecting animals from death after being infected with inhalation anthrax (post-exposure prophylaxis before the onset of symptoms). In those studies, Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax when treatment was initiated within 24 hours of challenge compared to 0% survival rate in placebo-treated animals.

Under the FDA's "Animal Efficacy Rule," drug sponsors must show that the treatment is effective in two animal species and must demonstrate safety in human clinical studies. The study results announced today will support the efficacy component of the Company's planned regulatory filing for marketing approval in anthrax. In addition, the safety database of over 5,000 human patients enrolled in over 50 clinical studies involving Restanza, which was validated in a positive 11-3 vote by a recent FDA advisory committee for the indication of community-acquired pneumonia, can support the safety component of the regulatory filing for marketing approval in anthrax.

"The successful outcome of this pivotal study, combined with our substantial data set showing the Restanza efficacy preventing anthrax infection post-exposure, provides strong validation of Restanza's broad utility as a life-saving treatment for anthrax and as a potent new biodefense agent," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "We believe that the government continues to be pleased with our progress and we anticipate achieving important milestones in our biodefense program in the near-term. We expect key data to be available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009. If these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, we plan to meet with the FDA to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010."

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.

In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.

FDA's "Animal Efficacy Rule" and the Use of Non-Human Primates

The FDA's "Animal Efficacy Rule" allows for approval of new drug products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the "Animal Efficacy Rule" is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product's approval was based on efficacy studies conducted in animals alone.

The non-human primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to the FDA's "Animal Efficacy Rule" (21 C.F.R. Section 314.600-650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.

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. For more information, please visit us on the web at

Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Advanced Health Media Named to 2009 Inc. 5000 List of Americas Fastest Growing Private Companies
2. Quality of Medicines Advanced by Agreement Between USP, Mexican Standards Body
3. Palliative care intervention for patients with advanced cancer provides quality of life benefits
4. Oral Drug Ups Survival in Advanced Prostate Cancer Cases
5. Foundation Radiology Group and Vital Images Partnership Brings Advanced Visualization to Small Medical Communities Nationwide
6. Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prostate Cancer
7. Londons Barts Hospital Selects Varian Equipment to Offer Advanced Radiotherapy to More Cancer Patients
8. New Kodak Training Facility Showcases the Latest in Dental Technology, Solutions from Advanced Automation: Networking Solutions, Dental Practice Management and Dental X-Ray Integration
9. Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix for injection) for Advanced Prostate Cancer Treatment
10. Advanced targeted therapies effective as first-line treatment for lung cancer
11. Smith & Nephew Highlights Advanced Wound Management Progress
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... ... giving viewers the lowdown on sciatica in a new episode of "Success Files," ... on current events and innovation and investigates each subject in-depth with passion and ...
(Date:10/12/2017)... WILMINGTON, Del. (PRWEB) , ... October 12, 2017 ... ... technology and advisory services for healthcare compliance program management, will showcase a range ... and National Association for Assisted Living (NCAL) Convention and Expo to be held ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ), one ... an innovative new design of the shoulder pad. The shoulder pad provides optimal ... controlling your pain while using cold therapy. By utilizing ice and water that is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the Los ... article to the newly revamped Cosmetic Town journal section, featuring articles ... procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi says ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and ... 2017 Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will ... Friday, Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... FLINT, Mich. , Oct. 2, 2017 ... acquired 8th Day Software and Consulting, LLC , ... 8th Day Software, based in Tennessee ... Management LLC. 8th Day expands EnvoyHealth,s service offerings for ... product development. "In ...
(Date:10/2/2017)... Oct. 2, 2017  AllianceRx Walgreens Prime, the combined ... Walgreens and pharmacy benefit manager Prime Therapeutics LLC (Prime), ... which included the unveiling of new signage at its ... well as at a few other company-owned facilities across ... to patients, some of whom will begin to see ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... ...
Breaking Medicine Technology: