Robustaflavone is a novel anti-hepatitis B virus (HBV) chemotherapeutic agent derived from natural sources. Hepatitis B is one of the most common, serious infectious diseases in the world, with an estimated 350 million people worldwide who are already chronic carriers of HBV. Hepatitis B is also one of the leading causes of death worldwide, resulting in over one million deaths every year.

Robustaflavone is the first non-nucleoside analogue reported to be active against hepatitis B, and its unique molecular structure is expected to possess a different resistance profile than drugs that are currently available. Robustaflavone has been found to act synergistically with nucleoside analogues, which makes it an attractive drug candidate for combination therapy for hepatitis B.

Robustaflavone is currently in preclinical development. In vitro testing has confirmed that Robustaflavone demonstrates potent inhibition of HBV replication, and is believed to be an inhibitor of the viral DNA polymerase enzyme. Advanced Life Sciences has initiated in vivo efficacy and toxicity testing of Robustaflavone.

Advanced Life Sciences, in collaboration with MediChem, has patented 2,3-DABA, a novel anti-inflammatory therapy for the treatment of Adult Respiratory Distress Syndrome(ARDS). This serious, and often fatal illness is estimated to effect over 150,000 people each year in the U.S. alone. What is even more startling is that the mortality rate for this illness ranges from 40% to 60%.

ARDS is triggered by inflammation to the lungs stimulated by conditions such as infection or trauma. An effective drug for the treatment of ARDS has not been developed and no specific therapy for ARDS currently exist. 2,3-DABA offers an advantage in ARDS therapy in its ease of manufacture, and its apparent low toxicity. Its oral and IV formulation properties also add to its convenience.

2,3-DABA is currently in preclinical development. In vivo studies have confirmed the synergistic effect of ibuprofen and 2,3-DABA in increasing the acute inflammatory response that is directly associated with the severe lung tissue injury inherent to ARDS. An important use of this drug combination is to block disease processes associated with ARDS. Animal toxicology studies have demonstrated an absence of toxicity, even at high doses.

MCR-47 is a novel anti-cancer agent discovered by scientists at MediChem in 1998 under the support of an initial SBIR grant from NIH. MCR-47 has been found to be a potent topoisomerase I inhibitor. Topoisomerase I is an attractive therapeutic target for the development of anti-cancer agents. This lead compound has demonstrated strong activity against colon, ovarian, and prostate cancer cells lines.

Advanced Life Sciences has an exclusive worldwide licensing agreement with the University of Illinois at Chicago for the development of betulinic acid, a compound that has shown activity against malignant melanoma. Malignant melanoma, commonly known as skin cancer, is increasing in its incidence and severity, and is on pace to become one of the most common cancers in the 21st century. Further pre-clinical and clinical development studies will be conducted by Advanced Life Sciences under this agreement. Scientists at the University of Illinois at Chicago originally isolated betulinic acid from the stem bark of Z. mauritania found in Zimbabwe. The compound was discovered to have cytotoxic activity specific for melanoma cells both in vitro and in vivo. A UIC research team, led by John Pezzuto, College of Pharmacy associate dean for research and graduate education, discovered the compound's therapeutic properties as part of a National Cancer Institute funded, systematic study of the world's plants and other natural sources for their potential to treat cancer. The researchers have shown that betulinic acid kills melanoma cells in tissue culture through apoptosis (a process whereby cells program themselves to die) and halts the growth of human melanoma carried in immunodeficient mice. Unlike traditional chemotherapy, betulinic acid has no obvious side effects.

Advanced Life Sciences, Inc. succeeds with its strong outside consultant network. The company has retained a sophisticated network of consultants with expertise in a variety of drug discovery and development fields including virology, cancer screening, animal toxicology, clinical trial design and management, drug formulation and drug manufacturing.  These consultants have worked with the Company on a number of projects and represent a responsive and reliable resource in achieving project objectives.

• NCI CRADA
      Advanced Life Sciences and the national Cancer Institute have established a CRADA to identify and capitalize on the therapeutic value of the Calanolide-class of anti-HIV compounds.

    The objective of this alliance is to combine the chemical research experience of Advanced Life Sciences with the biological expertise of NCI to advance the Calanolide compounds to commercialization.
   

National Cancer Institute Homepage

• ARGONNE CRADA
      Advanced Life Sciences has also established a CRADA with Argonne National Laboratory.  This CRADA was established to combine the synthesis and medicinal chemistry expertise of Advanced Life Sciences with the computational chemistry and structural biology strengths of Argonne.

    The aim of this collaboration is to further the discovery and development of new drug candidates that inhibit Amyloid Fibril Formation which is suspected to be a cause of Alzheimer's disease.  Research work is ongoing between Advanced Life Sciences and Argonne.

     
Argonne Laboratories Homepage

• SOUTHERN RESEARCH INSTITUTE CRADA

   Advanced Life Sciences and Southern Research Institute (SRI) have established a research collaboration to discover and develop novel anti-viral agents.

    The goal of this collaboration is to bring together Advanced Life Sciences' expertise in Conventional and Combinatorial Synthesis and the high-throughput anti-viral screening capabilities of SRI to discover and develop new anti-viral drug candidates.
   

Southern Research Institute Homepage

• BALL HELIX CRADA

   Advanced Life Sciences and Ball Helix, a subsidiary of George Ball Seed Company, a global ornamental seed producer, have established a research collaboration to discover, develop and commercialize new drug candidates found in exotic plant specimens supplied by Ball Helix.

   Ball Helix has the capability to access sources of rich plant biodiversity from many parts of the world.  Advanced Life Sciences' scientists have knowledge of traditional Chinese medicine and skills in natural product chemistry that guide the systematic search for new medicinal agents from Ball Helix plant sources.

• WALTER REED ARMY HOSPITAL CRADA
      Advanced Life Sciences and Walter Reed Army Hospital have established a CRADA to discover and develop novel anti-malaria agents.

    This collaboration is focused on coupling Advanced Life Sciences' expertise in Conventional and Combinatorial Synthesis and the high-throughput anti -malaria screening  capabilities of Walter Reed to discover and develop new anti-malaria drug candidates.