CytRx, Nycomed Enter Purification Supply Agreement

CytRx Corp. (Atlanta) has entered a supply agreement with Nycomed Inc. (Rennsselaer, NY) whereby Nycomed will provide CytRx with commercial-scale quantities of bulk drug for CytRx's Flocor purified poloxamer 188. Nycomed will perform purification, testing, and release of purified poloxamer 188 in accordance with CytRx specifications and procedures in a cGMP-compliant facility. Nycomed will also perform equipment and process validations and assist with regulatory interactions.

J. Michael Grindel, CytRx's VP of Drug Development, remarked that he hopes his company's relationship with Nycomed will be "long-term," noting that the deal complements an existing agreement CytRx has with Abbott Laboratories. "Under the Abbott agreement, Abbott will sterile fill Flocor for Injection as well as assist with regulatory interactions on the final drug product. With the consummation of the Nycomed agreement, we now have secured long-term suppliers for the complete manufacturing cycle for Flocor."

Flocor is a highly purified form of the non ionic surfactant poloxamer 188. Structurally, Flocor is composed of a central block of hydrophobic poly(oxypropylene) flanked by chains of hydrophilic poly(oxyethylene). The average molecular weight of Flocor is 8,500 daltons.

CytRx's relationship with Nycomed represents more than a simple purification agreement. Some time ago, CytRx discovered that low-level impurities—mostly unreacted monomer and small-molecular weight oligomers—present in commercial grade poloxamer 188 (then dubbed RheothRx) were contributing to the renal toxicity in clinical subjects. CytRx then devised a supercritical fluid extraction process for removing the nephrotoxic impurities without altering the beneficial properties of the compound. Flocor, the ultra-purified material resulting from the new purification scheme, is 63% less toxic than RheothRx. Flocor's more favorable therapeutic index—much more of the drug can be administered before adverse events crop up—made RheothRx obsolete.

"CytRx has some supercritical fluid extraction capacity," said R. Martin Emmanuele, CytRx R&D Director, "but not on the scale needed to supply product for this stage of our development efforts. Also, Nycomed already has a GMP manufacturing infrastructure in place. So we're paying to have a building constructed on their premises, we're stocking the plant with extraction equipment, and eventually we'll train Nycomed on how to run the process."

Flocor intravenous solution is currently in pivotal Phase III clinical trials for treating acute painful crisis in sickle cell patients. Flocor is also in a Phase I/II trial in patients with acute lung injury and a Phase I trial in sickle cell patients with acute chest syndrome. If Flocor is approved for sickle cell anemia, CytRx will soon thereafter seek approval for other acute vaso-occlusive disorders such as stroke, shock, and heart attack.

Aside from Flocor CytRx's research pipeline includes anti-infectives, gene and drug delivery, vaccines, and animal feed additives.

For more information: R. Martin Emanuele, VP of Research & Business Development, CytRx Corp., 154 Technology Parkway, Norcross, GA 30092. Tel: 770-453-0107. Fax: 770-448-3357.

By Angelo DePalma