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 11, 2018
| Oncolix, Inc. |
| (Exact name of registrant as specified in its charter) |
| Florida |
| 333-192405 |
| 46-3046340 |
| (state or other jurisdiction of incorporation) |
| (Commission File Number) |
| (IRS Employer Identification Number) |
| 14405 Walters Road, Suite 780 Houston, TX | 77014 | |
| (address of principal executive offices) |
| (zip code) |
| 281-402-3167 |
| (registrant’s telephone number, including area code) |
| ___________________________________________ |
| (former name or former address, if changed since last report) |
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 (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure
Oncolix, Inc. (“Oncolix” or the “Company”) is furnishing this information pursuant to Item 7.01 of this Current Report, which information shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information furnished pursuant to Item 7.01 in the Report that is required to be disclosed solely by Regulation FD.
On October 1, 2018, Oncolix and IGL Pharma, Inc. (“IGLP”) entered into a patent and technology license agreement and trademark assignment wherein IGLP hereby granted to Oncolix a royalty-bearing, sublicensable, exclusive license to a novel drug for the potential treatment of osteosarcoma, bone metastases and bone marrow ablation. Included in this license are the rights to manufacture, have manufactured, use, import, offer to sell and/or sell products. The license includes a customary upfront payment, milestone payments and royalties on product net sales in exchange for the exclusive global rights to the drug.
Osteosarcoma is a fairly rare disease (U.S. incidence of 800 to 900 patients) that affects both adolescents and adults. While the cure rate in local osteosarcoma is about 70%, in metastatic disease it is fatal. In addition to the need for better therapies to treat the disease, there is also a need to reduce the pain associated with bone cancers. Bone pain is associated with all bone cancers, including bone metastases, which often originate from prostrate and breast cancer.
Although osteosarcoma will be our first target, the preclinical data demonstrate that this drug may be effective for the treatment of bone metastases and bone marrow ablation. Bone marrow ablation is a viable option for many cancers, including leukemia, lymphoma and sickle cell anemia. In the case of sickle cell anemia, bone marrow ablation is the only known cure. The current standard for bone marrow ablation is high doses of chemotherapy, which are known to cause significant side effects.
Item 9.01 Financial Statements and Exhibits.
(b) Exhibits.
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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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| Oncolix, Inc. |
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| Dated: October 11, 2018 | By: | /s/ Michael T. Redman |
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| Michael T. Redman |
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| Chief Executive Officer |
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EXHIBIT 99.1
Oncolix, Inc. Finalizes CycloSam® License
Agreement For Osteosarcoma
HOUSTON, TX, October 11, 2018 – Oncolix, Inc. (OTCQB: ONCX) (the “Company”), a biotechnology company focused on gynecological cancers, announced that the Company has finalized its license agreement from IGL Pharma, Inc., (“IGLP”) for a novel, clinical stage drug for the treatment of osteosarcoma. Other potential indications include bone metastases and bone marrow ablation.
Highlights:
· License includes all uses for the drug, a radiopharmaceutical, Samarium-153 DOTMP (CycloSam®). · The terms include an undisclosed upfront payment, milestones and royalties on product net sales in exchange for the exclusive global rights to the drug. · The license includes the use of the drug for all disease indications, including bone cancers. · The drug has already completed preclinical toxicology studies and has clearance from the FDA to commence a Phase I clinical trial for the indication of osteosarcoma.
Osteosarcoma is a rare disease (US incidence of 800 to 900 patients) that affects both adolescents and adults. While the cure rate in local osteosarcoma is about 70%, in metastatic disease it is fatal. In addition to the need for better therapies to treat the disease, there is a need to reduce the pain associated with bone cancers. Bone pain is associated with all bone cancers, including bone metastases, which often originate from prostate and breast cancer.
Bone marrow ablation is a viable option for many cancers, including leukemia, lymphoma and sickle cell anemia. In the case of sickle cell anemia, bone marrow ablation is the only known cure. The current standard for bone marrow ablation is high doses of chemotherapy, which are known to cause significant side effects.
“We are pleased to license this very exciting drug candidate,” said Michael Redman, CEO of Oncolix. “While our first target will be osteosarcoma, we plan to expand its use into bone metastases and bone marrow ablation, two additional large potential markets. Oncolix now has two promising oncology drugs in clinical stages.”
C. Richard Piazza, IGL’s President and CEO said, “In pursuing the clinical advancement of CycloSam®, the offer from Oncolix presented us with an attractive opportunity to see realization of our drug’s potential.”
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About Oncolix
Oncolix is a clinical-stage biotechnology company developing Prolanta™ for the treatment of ovarian, uterine, breast and other cancers. The Company has a US FDA-cleared IND to commence human testing of Prolanta™ in its first indication, the treatment of ovarian cancer. This Phase 1 clinical trial is currently in progress. Prolanta™ is a prolactin receptor antagonist (or blocker) that has demonstrated efficacy in xenograft models through a unique mechanism of action, autophagy. In addition to ovarian cancer, there is strong preclinical evidence Prolanta™ may be effective in breast, prostate and other cancers. In the current Phase 1 dose-escalation safety trial for the treatment of ovarian cancer, to date there have been no observed serious adverse events and no dose-limiting toxicities. The FDA has approved the designation of Prolanta™ as an Orphan Drug for the treatment of ovarian cancer.
About IGL Pharma
IGL Pharma is a spinout out from IsoTherapeutics Group (Angelton, TX), developers of CycloSam®.
Corporate contact:
Michael Redman
P: 281-402-3167
E: mredman@oncolixbio.com
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