BioXell announces start of Phase IIa trial of Elocalcitol in Male Infertility

Milan, Italy, November 19, 2007 - BioXell S.p.A. (SWX: BXLN) today announced the enrollment of the first patient in its Phase IIa trial of Elocalcitol in male infertility, a widespread condition currently with no effective treatment. The trial is designed to test the ability of Elocalcitol to improve sperm quality in infertile male patients. Results are expected for the end of 2008. The randomized, double-blind, placebo-controlled, parallel group study is being conducted at 8 Italian centers that are highly specialized in infertility, under the coordination of Professor Andrea Lenzi of the University of Rome. The trial will involve a total of 234 infertile male patients with poor sperm quality and no known specific causes of infertility, and will test Elocalcitol at doses of 75 mcg and 150 mcg versus placebo for an effect on various sperm parameters. Treatment duration is 4 months, preceded by 3 months of pre-screening/washout and one week of medication-free run-in, and with a one month follow-up after treatment. The primary endpoint is total sperm motility (percentage), with secondary endpoints including forward motility (percentage), total and forward motility (absolute value), morphology (atypical cells), conception rate, IL-8 seminal plasma levels, leukocytes in the semen, and safety and tolerability. Infertile men with leukospermia (increased number of seminal leukocytes) have previously been found to have significantly elevated levels of the chemokine IL-8 in their seminal plasma. Seminal plasma IL-8 levels have, in turn, been shown to be inversely correlated, with high significance, with several measures of semen quality. In a separate clinical trial completed last year, BioXell found that Elocalcitol treatment induced a significant decrease in IL-8 levels in the seminal plasma of patients suffering from chronic prostatitis, a disease which is often associated with infertility. These elements provide a strong rationale for carrying out the newly initiated clinical study, in view of a possible use of Elocalcitol to treat male infertility. Enrico Colli, Chief Medical Officer and Head of R&D at BioXell, commented, "Elocalcitol is emerging, through accumulated evidence from clinical and preclinical studies, as a potential treatment of choice for urological disorders with an inflammatory component. There are strong reasons to believe that male infertility, for which there is a large unmet medical need, may also be one of these indications, broadening the potential therapeutic range of our lead compound." About Male Infertility Infertility is defined by the WHO as the inability of a sexually active, non-contracepting couple to achieve pregnancy in one year. The condition affects about 20% of couples, with male factors at the origin of 50% of cases. Over a third of cases of male infertility are idiopathic, with abnormal semen analysis but no known etiologic factors. There are no FDA/EMEA-approved treatments for idiopathic male infertility, and most proposed treatments are ineffective or of unproven efficacy. A successful treatment would improve spontaneous pregnancy rates and/or improve the results of reproductive techniques. About BioXell BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat important urological, inflammatory, and related disorders with significant unmet medical needs. The Company was founded in 2002 as a spin-out from Roche. BioXell's strategic goal is to become a fully integrated pharmaceutical company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships. BioXell's lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, has successfully completed a Phase IIb clinical trial for Benign Prostatic Hyperplasia (BPH). Elocalcitol is currently in a Phase IIb clinical trial for Overactive Bladder (OAB) and in a Phase IIa trial for male infertility. In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. These include BXL746, to enter Phase IIa trials for post-surgical adhesions in 2008; MNAC13, an innovative new approach to the treatment of pain; and the TREM platform, with TREM-1 in development for the treatment of inflammatory conditions. In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 58 people and has sites in Milan, Italy and Nutley, NJ, USA. More information on BioXell can be found at: For further information, please contact: BioXell S.p.A. Rochat & Partners Alvise Sagramoso or Angela Evans Christophe Lamps or Jonathan Tel: +39 (0)2 210 49 51 Leighton Fax: +39 (0)2 210 49 529 Tel: +41 22 718 37 46 Fax: +41 22 786 54 58 Disclaimer This press release does not constitute or form part, or all, of any offer to sell or invitation to subscribe, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of this press release and any attached and/or referred material, if any, or their distribution form the basis of, or be relied on in connection with, any contract or investment decision in relation to any securities. This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of BioXell, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of BioXell, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on these forward-looking statements. BioXell disclaims any obligation to update these forward-looking statements to reflect future events or developments. --- End of Message --- bioXell S.p.A via Olgettina 58 Milan Italy WKN: A0J3MW; ISIN: IT0004069933 ; Listed: Main Market in SWX Swiss Exchange;