Columbia University

Technology Ventures

Synthetic Follicle Stimulating Hormone (FSH) for Infertility Treatment

Technology #1143

“Lead Inventor: Joyce W. Lustbader Ph.D.

Infertility Treatment with Follicle Stimulating Hormone (FSH) has Short Half-Life Infertility treatment Follicle Stimulating Hormone (FSH) is a glycoprotein hormone that is comprised of alpha and beta subunits. FSH stimulates the growth and recruitment of immature ovarian follicles in females; while in males, it stimulates sperm production. FSH products are a class of infertility drugs that directly stimulate the development of eggs within the ovarian follicles. However, due to the short half-life, the current formulation of FSH requires daily injection for 8-12 days, which brings about many side effects. Thus, there is unmet need for developing a long-acting FSH requiring less frequent administration. This technology provides novel hFSH analogues that have an increased serum half-life without sacrificing biological activity, offering a significant advantage over current approaches.

FSH Analogues have Increased Serum Half-Life Relative to FSH The technology provides FSH analogues that have an increased serum half-life relative to FSH. It also provides related compositions of FSH analogues and methods of producing these polypeptides. In addition, this invention provides methods for increasing fertility, egg production and spermatogenesis in a subject by administering an effective amount of the instant synthetic FSH.

Applications:
• The technology can be developed into hormonal therapy to treat infertility.
• It can be used to increase the efficacy of in vitro fertilization protocols.

Advantages:
• The composition has an increased serum half-life without sacrificing biological activity.
• These FSH analogues can be expressed as single chain polypeptides and are fully functional hormones without dimerization.
• These analogues are more easily purified than those that require separate expression of different subunits and subsequent dimerization.
• These FSH analogues do not need daily injection, reducing medical costs and injection pain for patients.


Patent Status: Patent Issued (7081446; 7202215) Patent Pending (20080234186) ~ see links below.

Licensing Status: Available for Licensing and Sponsored Research Support

Publications: Klein J, and Lustbadder JW. Pharmacokinetics and pharmacodynamics of single-chain recombinant human follicle-stimulating hormone containing the human chorionic gonadotropin carboxyterminal peptide in the rhesus monkey. (2002) Fertil Steril 77(6): 1248-55.