Form 8-K PROGENICS PHARMACEUTICAL For: Oct 05
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 5, 2018
Progenics Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware |
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000-23143 |
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13-3379479 |
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One World Trade Center, 47th Floor, New York, New York 10007 |
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(Address of Principal Executive Offices) (Zip Code) |
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Registrant’s telephone number, including area code: (646) 975-2500 |
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Not Applicable |
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(Former name or former address, if changed since last report) |
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On October 5, 2018, Progenics Pharmaceuticals, Inc. (“Progenics” or the “Company”) issued a press release announcing results of its Phase 2/3 trial of PyL, the Company’s prostate specific membrane antigen (PSMA)-targeted small molecule PET imaging agent that is designed to visualize prostate cancer. A copy of the foregoing press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated in this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release announcing results of the Company’s Phase 2/3 trial of PyL, dated October 5, 2018 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PROGENICS PHARMACEUTICALS, INC. |
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By: |
/s/ Patrick Fabbio |
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Patrick Fabbio |
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Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
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Date: October 5, 2018
Exhibit 99.1
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Progenics Pharmaceuticals, Inc. One World Trade Center 47th Floor, Suite J New York, New York 10007 (646) 975-2500 www.progenics.com |
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Contact: |
Melissa Downs Investor Relations (646) 975-2533 |
Progenics Reports Results of Phase 2/3 Trial of PSMA PET Imaging Agent PyL for the Detection of Prostate Cancer
-PyL highly sensitive, 93-99%, in reliably detecting metastatic prostate cancer lesions and highly specific, 96-99%, in confirming the absence of pelvic lymph node disease-
- Study data highlights the strong positive predictive values of PyL to detect prostate cancer in pelvic lymph nodes and metastatic lesions and supports continued development of PyL-
-Phase 3 trial to commence by year end -
- Conference Call at 8:30 AM Eastern Time-
NEW YORK, NY, October 5, 2018 – Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, today announced data from its OSPREY 2301 Study of PyLTM (18F-DCFPyL). PyL is the Company’s PSMA-targeted small molecule PET imaging agent designed to visualize prostate cancer. In the study, PyL demonstrated high sensitivity in reliably detecting distant metastatic prostate cancer lesions and high specificity in confirming the absence of pelvic lymph node disease. The associated strong positive predictive values (PPV) and negative predictive value (NPV) of PyL imaging in these disease settings indicate its potential high clinical utility.
Dr. Michael Morris, Associate Professor at Memorial Sloan Kettering, and a lead investigator of the trial said, “These are highly encouraging results in a large, well-controlled and rigorous trial showing PyL has excellent positive and negative predictive value in assessing the distribution of disease in men with high-risk prostate cancer. Furthermore, in men intended to go to surgery, the specificity of PyL was exceedingly good. Taken together, a PyL PET avid lesion is a reliable reflection of histologically proven disease and may provide additional important information to men with prostate cancer and their doctors. That information may provide important guidance in the decision-making for their treatment.”
| Progenics Reports Results of Phase 2/3 Trial of PSMA PET Imaging Agent | Page 2 |
Phase 2/3 Trial Results
The trial examined the diagnostic performance of PSMA-targeted PET imaging agent, PyL, to detect prostate cancer in pelvic lymph nodes in patients with high risk locally advanced prostate cancer (Cohort A) and distant metastases in patients with metastatic or recurrent (Cohort B) prostate cancer. The diagnostic performance of PyL PET imaging in this “gold standard” trial was evaluated against histopathology as the standard of truth. The OSPREY study dosed 385 patients with either high-risk locally advanced prostate cancer (268) or metastatic or recurrent prostate cancer (117). The study’s co-primary endpoints were the assessment of specificity and sensitivity of PyL PET imaging in Cohort A to detect prostate cancer in pelvic lymph nodes in patients scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. Key secondary endpoints for Cohort A were positive predictive value and negative predictive value. The study also evaluated several key secondary endpoints in Cohort B, including the sensitivity and positive predictive value of PyL PET imaging in detecting metastatic prostate cancer in patients where lesion biopsies (bone, soft tissues, lymph nodes other than pelvic lymph nodes) were feasible.
In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed a high specificity (96-99% among the three blinded independent readers), meeting the first co-primary endpoint of the trial, with the lower bound of the 95th percent confidence interval (94-96%) exceeding 80%. The sensitivity of 31-42%, did not meet the second co-primary endpoint, as the lower bound of the 95th percentile confidence interval (19-30%) did not exceed the required 40%. The positive predictive value and negative predictive value of pelvic lymph node detection were 78-91% and 81-84%, respectively.
In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and positive predictive value of 81-88% in detecting metastatic lesions. Specificity and negative predictive value were not endpoints specified in the protocol for Cohort B as all men in Cohort B were suspected to have disease.
PyL was very well tolerated. A total of 27 (7%) subjects experienced at least one treatment related adverse event. There were no serious adverse events related to study drug. The most frequent drug related events included dysgeusia (2.1%) and headache (2.1%).
“The data from this trial shows the strength of PyL in prostate cancer detection, and its potential to be highly valuable for disease and treatment monitoring,” said Dr. Vivien Wong, Executive Vice President of Development at Progenics. “While specificity and sensitivity are often used to describe diagnostic performance, PPV and NPV are increasingly considered more relevant indicators of actual clinical utility. Following our discussions with FDA, our Phase 3 trial design will use a primary endpoint based on PPV parameters in the biochemical recurrence setting.”
“PyL imaging holds great promise in transforming how physicians manage and treat high risk, metastatic, and recurrent prostate cancer,” said Mark Baker, Chief Executive Officer of Progenics. “Our data from OSPREY provides strong rationale for continued development, and we look forward to launching our Phase 3 trial by year-end.”
Progenics plans to submit the full results from the trial for presentation at a medical meeting.
| Progenics Reports Results of Phase 2/3 Trial of PSMA PET Imaging Agent PyL | Page 3 |
About PyL™ for PET Imaging of Prostate Cancer
PyL (also known as [18F]DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
Investor Conference Call
Progenics will host a conference call today at 8:30 AM Eastern Time to discuss the approval. The live and replayed webcast of the call will be available through the Company's website at www.progenics.com. To participate in the live call by phone, dial (877) 250-8889 (USA) or (720) 545-0001 (international) and enter the passcode 4282148. The replay of the call will be available for 90 days.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 161,360 new cases of prostate cancer will be diagnosed and about 26,730 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
About Progenics
Progenics develops innovative medicines and other technologies to target and treat cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (1404 and PyL); and imaging analysis technology. Progenics has two commercial products, RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation, which is partnered with Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals International, Inc.)); and AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy.
| Progenics Reports Results of Phase 2/3 Trial of PSMA PET Imaging Agent | Page 4 |
This press release contains "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements are generally accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, market acceptance for approved products; the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations, such as the anticipated launch of a Phase 3 trial for PyL; our ability to successfully develop and commercialize products, such as PyL, that incorporate licensed intellectual property; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission, including those risk factors included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, as updated in its subsequent Quarterly Reports on Form 10-Q. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company's SEC filings.
(PGNX-F)