Atrix Awarded SBIR Grants For Atrigel Drug Delivery

Atrix Laboratories' (Fort Collins, CO) drug delivery program received a shot in the arm when the company was awarded two Phase I Small Business Innovation Research (SBIR) grants from the National Institutes of Health to support the firm's Atrigel polymer drug delivery system. Each grant provides $100,000 under the SBIR Phase I program for Atrix Laboratories to demonstrate preclinical efficacy with the proposed product.

The first grant, from the National Cancer Institute, is directed toward the development of a sustained release chemotherapeutic product for the intratumoral treatment of head and neck cancer. Cisplatin, a potent anti-tumor agent, will be incorporated into Atrigel to provide sustained release of the drug for up to four weeks. The product will be injected directly into solid tumors of head and neck cancer where high concentrations of the drug for extended periods of time are expected to provide better efficacy and less systemic toxicity than when the drug is administered orally. The preclinical studies are being conducted at the University of Arizona Cancer Center.

Atrigel incorporates a broad range of drugs targeted at several important diseases

The second grant was awarded by the National Institute of Dental Research. In this progect, Atrigel will provide a fibrous film with sufficient porosity to promote the growth of bone cells which are collected from a donor site and cultured in the laboratory in combination with the film. Once the bone cells have reached a critical growth stage, the fibrous film containing the cells is placed into a non-healing boney site, such as a mandible defect, in order to produce new bone. In the initial phase of the program, polymer films with different compositions will be evaluated in cell culture, and the most promising materials will be evaluated preclinically for their efficacy in producing bone in non-healing boney defects. This study is being conducted with the University of Pittsburgh Schools of Medicine and Dental Medicine.

Atrigel Technology

Atrigel is a polymeric drug delivery system, comprised of biologically inert, biodegradable polymers and biocompatible carriers, which can incorporate a variety of different drugs. Although the system can take the form of solutions, gels, pastes and putties, the preferred applications are those in which liquid product is injected with a syringe and a small gauge needle.

When the delivery system interacts with tissue fluids, the polymer precipitates to form a solid implant at the disease site, which releases the drug in a controlled manner and subsequently biodegrades. The system can be designed for either local or systemic therapy. This biodegradable polymer system also has the potential to form biodegradable medical devices in situ. For some applications, the precipitated polymer without a drug may form a useful localized barrier function, such as guided tissue regeneration (GTR), surgery, or the prevention of surgical adhesions. In addition to providing a physical barrier to protect the wound from the external environment, Atrix polymers can also be used to prevent infections and stimulate healing by including antibiotics and growth factors, respectively, in the polymer system.

Atrix's commercialization pipeline. Atrigel for cancer treatment falls near the bottom of the chart, but could become the company's leading product.

Atrigel, which can be applied by pouring, painting or spraying onto the target tissue, is relatively easy and inexpensive to manufacture. Atrix believes that the unique combination of properties of the drug delivery system creates the potential for a wide variety of medical, dental and veterinary applications and provides benefits over traditional methods of drug administration such as pills, injections and continuous infusion as a result of the following benefits:

• Versatility: Atrigel may be used with a wide variety of pharmaceutical compounds from traditional synthetic molecules to peptides and proteins.
• Ease of Application: Atrigel can be injected or inserted as a solution, paste, gel or putty by means of ordinary cannulas and syringes, or through other appropriate means of placement.
• Biodegradability: Products biodegrade and thus are not expected to require removal when the drug is depleted.
• Localized Delivery: Drugs can be delivered directly to the target area, thus potentially achieving higher drug concentrations at the desired site of action and minimizing systemic side effects.
• Systemic Delivery: Atrigel can also be used to provide sustained drug release into the systemic circulation for those applications where the entire body requires treatment and the drug is not active when taken orally.
• Sustained Release: Reducing the frequency of drug administration.
• Cost: Manufactured using a simple and inexpensive process relative to other sustained-release, parenteral, drug delivery systems.
• Patient Compliance: Not an issue since the drug is implanted and released over time.
• Safety: All components of the Atrigel drug delivery system are biocompatible and have independently established safety and toxicity profiles. In addition, the polymers used in the system are members of a class of polymers which have previously been approved by the FDA for human use in other applications.

Examples of the types of drugs delivered with Atrigel include: anesthetics; antibiotics; antigens (vaccines); antimicrobials; antineoplastics; antipsychotics; cytokines; enzymes; growth factors; hormones; narcotic antagonists; and non-steroidal antiinflammatory drugs. Primary target disease applications for the ATRIGEL technology include orthopedic surgery, post-operative pain and solid tumor cancers. Other promising potential areas include osteomyelitis, dermal wounds and ulcers, hormone replacement therapy, chronic anemia, vaccination/immunization, heroin addiction and schizophrenia.

For more information: Vicki Miller, Atrix Laboratories, Inc., 2579 Midpoint Dr., Fort Collins, CO 80525, USA. Telephone: 970-482-5868.