AAA announces first patients dosed in 2 clinical studies with PSMA-R2 for prostate cancer

Saint-Genis-Pouilly, France, June 22, 2018 – Advanced Accelerator Applications S.A. (AAA), a Novartis company and leader in nuclear medicine theragnostics, today announced that the first patients have been dosed in two Phase I/II clinical studies of radiolabeled PSMA-R2, a urea-based ligand of Prostate-Specific Membrane Antigen (PSMA), which is commonly expressed on prostate cancer cells.

The PROter study is an open-label, multi-center, dose-escalation/dose-expansion trial evaluating treatment with 177Lu-PSMA-R2 RadioLigand Therapy in patients with PSMA positive progressive, metastatic castration-resistant prostate cancer following previous systemic treatment. Primary objectives for Phase I include characterizing the drug's safety profile and tolerability, as well identifying a recommended Phase II dose. The primary objective for Phase II is assessment of antitumor activity, as measured by radiographic progression-free survival. Other objectives include prostate-specific antigen (PSA) response, time to PSA progression and overall survival. Approximately 96 patients are expected to be enrolled in the PROter trial.

The PROfind study is an open-label, multi-center trial evaluating Positron Emission Tomography (PET) imaging with 68Ga-PSMA-R2 in patients with biochemical relapse and metastatic prostate cancer. The primary objective of the study is to assess the safety and tolerability of a single administration of 68Ga-PSMA-R2. Secondary objectives include evaluation of pharmacokinetics, biodistribution and dosimetry of 68Ga-PSMA-R2, as well as comparison with conventional imaging modalities. Approximately 30 patients are expected to be enrolled in the PROfind trial.

"Advancing PSMA-R2 into clinical studies is a major milestone for AAA," commented Germo Gericke, M.D., Head of Research and Development at Advanced Accelerator Applications. "This is the second theragnostic program in our oncology pipeline and we are eager to explore the full potential of this innovative platform in large patient populations, such as prostate cancer."

Prostate cancer is the second most common type of cancer in men worldwide leading to substantial morbidity and mortality1. It represents the second most common cause of cancer death in men in the USA and the third most common cause of death in developed countries2,3. Most cases of prostate cancer are curable if diagnosed at an early stage. Nevertheless, up to 40% of the patients with prostate cancer develop biochemical relapse within 10 years after initial local treatment with curative intent4 and some patients will progress to metastatic prostate cancer. Despite the effectiveness of hormone therapy in the treatment of metastatic prostate cancer, patients who live long enough will ultimately succumb to metastatic castration-resistant prostate cancer.

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More information about the PROter study may be found at: https://www.clinicaltrials.gov/ct2/show/NCT03490838?term=NCT03490838&rank=1

More information about the PROfind study may be found at: https://www.clinicaltrials.gov/ct2/show/NCT03490032?term=NCT03490032&rank=1

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Advanced Accelerator Applications S.A.

Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing radioligand theragnostics. AAA is an established leader in radiopharmaceuticals for Positron Emission tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging, mainly used in clinical oncology, cardiology and neurology. For more information, please visit: https://www.adacap.com/.

References

1 Torre LA, Bray F, Siegel RL, et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015; 65(2):87-108.

2 Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009; 59:225-49.

3 American Cancer Society. Global cancer facts and figures 3rd Edition. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-3rd-edition.pdf.

4 Isbarn H, Wanner M, Salomon G, et al. Long-term data on the survival of patients with prostate cancer treated with radical prostatectomy in the prostate-specific antigen era. BJU International. 2010; 106(1):37-43.

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