Steptoe Therapeutics Technology Presented at Meeting of the ASRM Conjoint with the Meeting of the International Federation of Fertility Societies (IFFS) (Boston, MA)

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The treatment of a condition caused by fertility drug shows promising results.

Steptoe Therapeutics, Inc., a small biotech private company focused on the development of new treatments for infertility, announced today the presentation of clinical results regarding the use of a cytokine in combination with clomiphene citrate (CC), the most popular fertility drug used for infertility. The abstract (P-384) authored by Dr. Fujii (Kanazawa Medical University, Japan) and collaborators includes the technology covered by US Patent 8,183,205B2 (‘205 Patent) exclusively licensed to Steptoe Therapeutics.

The use of this cytokine (G-CSF) in ovulation induction is investigational and not approved by the Food and Drug Administration (FDA) in the US. The study was entirely conducted in Japan by the authors.

The paper, titled “Granulocyte colony-stimulating factor (G-CSF) prevents luteinized unruptured follicle (LUF) caused by clomiphene treatment” shows a remarkable improvement in ovulation rate in patients suffering from LUF during ovulation induction with clomiphene citrate and hCG. Patients previously diagnosed with LUF underwent a similar stimulation regimen with the addition of G-CSF therapy. Almost all cycles (90.9%) ovulated with documented oocyte release by ultrasound after a single treatment cycle with G-CSF and about 6% (4/66) of them delivered a baby.

“LUF is a rare condition that includes the luteinization of the ovarian follicle without oocyte release. When this happens, indirect markers of ovulation, like elevation of progesterone, are present but no oocyte release occurs. This may partially explain the clinical discrepancy between “ovulation” and pregnancy rates observed in CC cycles. The chances of achieving a pregnancy during LUF cycles are highly reduced or absent,” said Professor Makinoda, M.D. Ph.D., from Kanazawa Medical University, Kanazawa, Japan, the inventor in the ‘205 Patent.

Diagnosis of LUF is difficult, controversial and only performed by serial pelvic ultrasound around ovulation and early luteal phase. There is no current approved treatment for LUF and the condition may be overcome with multiple clomiphene citrate cycle treatment attempts or more successfully with the use of assisted reproductive technologies (ART). In ART, the oocytes are retrieved from the ovary through ultrasound-guided aspiration after controlled ovarian stimulation (COS) with gonadotropins.

Clomiphene citrate is the initial treatment of choice for most anovulatory or oligo-ovulatory infertile women. In a recent trial, 475 women were observed for up to 3 cycles of CC and intrauterine insemination - IUI (Reindollar et al, 2010). There were 123 pregnancies over 1,294 cycles and 98 ongoing or live births (7.6% ongoing or live births per cycle).

In another publication (Qublan et al, 2006) a total 167 patients who underwent first CC cycle, 42 (25%) had LUF. The incidence of LUF was 56.5% in 69 patients who underwent a second CC cycle, of whom 33 patients had LUF in the first cycle with recurrence rate of 78.6%. In 56 patients who underwent 3 consecutive cycles, the incidence of LUF was 58.9% and recurrence rate of 90%. No pregnancies were recorded in patients with LUF during the study period.

The incidence of LUF is highly influenced by the type of ovulation induction therapy used and the presence of other medical conditions like endometriosis.

Steptoe Therapeutics is planning on developing G-CSF for ovulation induction. The company expects to file an Investigational New Drug (IND) application with the FDA early next year starting clinical trials in the US immediately thereafter.

“We believe that there is a chance to improve the outcomes of ovulation induction therapy with clomiphene citrate. This is a very popular entry-level therapy with low pregnancy rates per initiated cycle. Many patients have high expectations with this therapy and it happens that in many cases the ovulation signs are present but the oocyte stays trapped inside the follicle. No egg release no pregnancy and more treatment cycles are needed with increase cost emotionally and financially,” said Dr. Eduardo Kelly, the company CEO, a Reproductive Endocrinologist and Embryologist with 24 years of experience in the reproductive medicine field.

About Infertility
Infertility affects about 7.3 million women and their partners in the U.S., about 12% of the reproductive-age population (Source: National Survey of Family Growth, CDC 2002). Irregular or abnormal ovulation accounts for approximately 25 percent of all female infertility problems. Clomiphene citrate therapy is widely used among OBGYNs and Reproductive Endocrinologists. The Company estimates that about 700,000 CC treatment cycles are prescribed in the US. Failure to conceive after 3 to 4 successful CC-induced ovulation cycles is indication for further evaluation to exclude other contributing causes of infertility, particularly in women >35 years of age (ASRM 2013).

About Steptoe Therapeutics
Steptoe Therapeutics is a small privately owned Biotech Company focused on developing new therapies for infertility patients. The Company’s patented technology includes the use of a cytokine (G-CSF) to prevent and treat a condition called Luteinizing Unruptured Follicle (LUF) caused by the fertility drug clomiphene citrate. Steptoe Therapeutics follows a virtual company model keeping development cost low using the talent of recognized leaders in reproductive medicine. For more information visit http://www.steptoetherapeutics.com.

Contact:
Eduardo Kelly MD
Chief Executive Officer
Steptoe Therapeutics, Inc.
10 Keithway, Suite 3
Hingham, MA 02043
eduardo(at)steptoetherapeutic(dot)com
508-631-4254

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Eduardo Kelly MD
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