On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery
WEST LAFAYETTE, Ind., March 3, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Priority review for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during surgery. Many cancers, including over 95%1 of ovarian cancer, over-express folate receptors to enable the uptake of folic acid. Pafolacianine sodium injection is a novel molecule which is shown to bind to folate receptors and illuminate intraoperatively under near-infrared light, serving as an adjunct to provide greater certainty in a complete resection. It is administered via standard IV in as little as one hour before surgery.
The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period from the standard 10 months to six months from the acceptance of the NDA. Pafolacianine sodium injection was investigated for use in ovarian cancer under Special Protocol Agreement and received both Fast Track and Orphan designations from the FDA. Additionally, pafolacianine sodium injection is being investigated in lung cancer under Fast Track designation.
Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. The American Cancer Society estimates that in 2021 about 21,410 women in the United States will receive a new diagnosis of ovarian cancer and about 13,770 women will die from ovarian cancer2.
"Our NDA is supported by our positive Phase 2 and Phase 3 clinical trials. As we move closer to FDA approval for ovarian cancer, we are realizing our mission to intra-operatively visualize more cancer and extend the benefits of a complete resection to patients," said Christopher Barys, President and CEO of On Target Laboratories.
About Fluorescence-guided Surgery
To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories' fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, enabling surgeons to see and remove more cancerous tissue that otherwise may have gone undetected.
On Target's first novel compound, pafolacianine sodium injection, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A single dose of the compound is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared camera.
About Pafolacianine Sodium Ovarian Clinical Results
Clinical trials for the use of pafolacianine sodium as an intraoperative adjunct to aid in the surgical treatment of ovarian cancer have been conducted in the United States and Europe. Phase 2 results were previously published in the journal Gynecologic Oncology, which reported surgeons were able to detect additional lesions, regardless of tissue location, in 48.3% of patients. Further, pafolacianine sodium injection demonstrated a sensitivity of 97% when controlling for detection correlation of multiple lesions within a single patient3.
About On Target Laboratories, Inc.
On Target Laboratories discovers and develops fluorescent markers to target and illuminate cancer during surgery so cancerous tissue can be removed more completely. Their intraoperative molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, aims to reduce the uncertainty associated with finding and removing cancerous tissue during surgical procedures, helping surgeons to provide a more precise and complete surgical resection. Pafolacianine sodium injection, the Company's first product, is currently under priority review for ovarian cancer and is being studied in the Phase 3 ELUCIDATE Trial for lung cancer in the US. It is not yet approved. For more information visit www.ontargetlabs.com.
1.Markert S, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008 (28): 3568-3572.
2.American Cancer Society. 2021. Key Statistics for Ovarian Cancer. Accessed March 2021. https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html.
3.L.M. Randall, R.M. Wenham, P.S. Low, et al., A phase II, multicenter, open-label trial of OTL38 injection for the intraoperative imaging of fola..., Gynecologic Oncology, https://doi.org/10.1016/j.ygyno.2019.07.010
SOURCE On Target Laboratories, Inc.
Posted: March 2021