Activated Cell Therapy Inc. (ACT) announced Wednesday thatit has appointed Russell Hays as president and chief executiveofficer. Hays held similar positions at Enzytech Inc. Beforejoining Enzytech, which merged with Alkermes Inc. lastFebruary, Hays was vice president and general manager of theImmunotherapy Division of Baxter Biotech, a subsidiary ofBaxter Healthcare Corp.

Hays' experience in immunotherapy will dovetail with ACT'sclinical focus. The Mountain View, Calif., company was foundedin 1992 to develop living cell therapies and related productsfor the treatment of cancer, autoimmune disease and chronicviral infection.

According to the company, ACT has developed a method of"selectively enriching" peripheral blood stem cells (PBSCs) andother specific blood-cell populations based on cell densities. Asa short-term goal, ACT hopes to develop an application of thistechnology for restoring immune system function in patientsfollowing ablative high-dose chemotherapy or radiationtherapy.

The enrichment is accomplished through what is essentially aspecialized centrifugation process, Hays told BioWorld. Specificsubsets of cells can be isolated through the company'sproprietary process and then proliferated in vitro before beingreintroduced to the body. Transplanted cells used in theprocess may either come from the donors themselves or fromfamily members.

Hays said the process will decrease time to immune restorationfollowing treatments such as chemotherapy and will lowertreatment costs in comparison with traditional bone marrow orPBSC transplantation procedures. The company also believes itsdensity gradient technology will reduce graft-vs.-host disease(GvHD) while maintaining beneficial graft-versus-leukemiaeffects. Clinical trials of the company's immune restorationtechnique will take place this year under the sponsorship ofthe Stanford University Institutional Review Board, Hays noted.He added that ACT can conduct its enrichment process withoutthe use of any exogenous biological products and believes thismay streamline the regulatory review of its products.

ACT intends to develop cell enrichment-based therapies for Bcell lymphoma, breast cancer, acute and chronic leukemia, AIDSand prostate cancer.

In addition to immune restoration, two additional technologiesbased on the company's cell enrichment technology may helpACT realize this goal. The first involves double-negativesuppresser T cells (DNS cells), which the company believes cansuppress GvHD. A cytokine produced by DNS cells called naturalsuppresser factor can block cellular response to a wide range ofantigens. ACT hopes DNS cells and the suppresser cytokine canbe used in bone marrow and other transplants, and againstautoimmune diseases such as severe rheumatoid arthritis.

ACT is also developing a technology to activate cytotoxic Tlymphocytes against specific tumor or viral antigens. Thecompany said it can isolate rare bone marrow-deriveddendritic cells that are highly efficient in presenting antigensfrom the peripheral blood stream. The cells can then be used toimmunize patients against the same antigens, ACT said. Thetechnology will be used in a transplant therapy to eliminateremaining tumor cells after ablative chemotherapy andimmune restoration, ACT said. The company hopes to later usethis technology for the treatment of breast cancer and othertumors and chronic viral diseases.

ACT became operational in 1993, funded by $5 million in seedcapital from HealthCare Investment Corp. of Edison, N.J. Theinvestors have committed to financing the company with anadditional $5 million by the end of the year, Hays said. Itsthree technologies were developed by its scientific co-founders,Samuel Strober and Edward Engleman of Stanford University.The technologies have been licensed from Stanford.

-- Karl A. Thiel Business Editor

(c) 1997 American Health Consultants. All rights reserved.