May 2005

Armand M. Karow, Ph.D.Xytex Corporation

Augusta, GA

Women at Risk ofCytotoxic Sterility:

Federal Involvement in Reproductive Tissue

Preservation

Xytex Corporation

Cytotoxic therapy:

• Chemotherapy• Radiation therapy

Curative but also reproductive sterility• Cancer• Bone marrow transplants• Autoimmune diseases

Xytex Corporation

Xytex Corporation

Talking points:

• Avoiding reproductive sterilization• Avoiding federal involvement in

clinical practice

Xytex Corporation

Xytex Corporation

Follicle Cells

Injured by Cytotoxic Rx

• Oocytes• Granulosa• Thecal cells

Xytex Corporation

Xytex Corporation

Consequences (50%)

Premature ovarian failure

Premature menopause

Sterility

Xytex Corporation

Xytex Corporation

Consequences: Fertility (40%)

With:Early pregnancy loss

Premature labor

Low birth-weight infant

Xytex Corporation

Xytex Corporation

Protecting FemaleReproductive Capacity

Physical Shield

Pharmacological Shield

Xytex Corporation

Xytex Corporation

Isolation and Storage of Female Germinal Material

Tissue Cryopreservation

Xytex Corporation

Xytex Corporation

Embryo Cryopreservation40% pregnancy rate

Isolation and Storage of Female Germinal Material

Xytex Corporation

Xytex Corporation

Oocyte Cryopreservation< 3% pregnancy rate

Isolation and Storage of Female Germinal Material

Xytex Corporation

Xytex Corporation

Ovarian Tissue Cryopreservation

New Option Being Tried in Humans

Isolation and Storage of Female Germinal Material

Xytex Corporation

21 CFR Part 1271Human Cellular and

Tissue Based Products25 May 2005

Xytex Corporation

21 CFR Part 1271Regulates the Processor

Not the Tissue

Not the Process

Xytex Corporation

Xytex Corporation

21 CFR 1271- Subparts

A. General ProvisionsB. Procedures for Registration and

ListingC. Donor EligibilityD. Current Good Tissue PracticesE. Additional RequirementsF. Inspection and Enforcement

Xytex Corporation

Xytex Corporation

21 CFR 1271Processors of Autologous

TissuesA. General ProvisionsB. Procedures for Registration and

ListingC.D. Current Good Tissue PracticesE. Additional RequirementsF. Inspection and Enforcement

Xytex Corporation

Xytex Corporation

21 CFR 1271Processors of Autologous

Reproductive Tissues

A. General ProvisionsB. Procedures for Registration and

ListingC.D.E.F. Inspection and Enforcement

Xytex Corporation

You are regulated by21 CFR 1271 if:

You minimallymanipulate tissues.

(IVF programs DO these activities)

Xytex Corporation

Xytex Corporation

You are NOT regulated by21 CFR 1271 if:

You receive transplantable tissues from a regulated

entity.

Xytex Corporation

Xytex Corporation

Copy of 21 CFR 1271 from

www.xytex.com

Xytex Corporation