FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the Month of April, 2012
Commission File Number 1-32001
Lorus Therapeutics Inc.
(Translation of registrant’s name into English)
2 Meridian Road, Toronto, Ontario M9W 4Z7
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):82-_______________.
SIGNATURE
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, thereunto duly authorized.
Lorus Therapeutics Inc. | ||
Date: April 4, 2012 | By: | /s/ “Elizabeth Williams” |
Elizabeth Williams | ||
Director of Finance and Controller |
EXHIBIT INDEX
99.1 | Lorus Therapeutics News Release dated March 20, 2012 - Lorus Therapeutics Announces Issuance of Patent for Anticancer Drug LOR-253 in Canada |
99.2 | Lorus Therapeutics News Release dated March 27, 2012 - Lorus Therapeutics Announces Positive Results from its Small Molecule Antimicrobial Program |
99.3 | Lorus Therapeutics News Release dated April 3, 2012 - Lorus Therapeutics Presents Positive Data for Lead Anticancer Drug LOR-253 |
Exhibit 99.1
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NEWS RELEASE |
Lorus Therapeutics Announces Issuance of Patent
for Anticancer Drug LOR-253 in Canada
TORONTO, CANADA, March 20, 2012 - Lorus Therapeutics Inc. (TSX: LOR) (“Lorus”), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that the Canadian Patent Office has issued Lorus’ patent for its lead small molecule anticancer drug LOR-253. The patent provides Lorus with exclusive rights to LOR-253 in Canada until 2026.
The Canadian patent covers LOR-253 composition of matter and its use in the treatment of a wide range of cancers, including non-small cell lung, colon, breast, and prostate tumors, as well as melanoma and leukemia. Patents with similar protection for LOR-253 have also been issued in Australia and are pending in other major jurisdictions.
“Lorus is committed to obtaining strong patent protection for LOR-253 in major markets,” said Dr. Aiping Young, Lorus' President and CEO. “This new patent gives us long-term protection for LOR-253 in Canada, and we consider it to be a valuable asset in our expanding IP portfolio for this novel cancer therapy.”
LOR-253 is in a Phase I clinical study in patients with advanced or metastatic solid tumors who are unresponsive to conventional therapy or for which no effective therapy is available. The main objectives of the study include assessing the safety profile and antitumor activity of LOR-253, as well as determining the recommended Phase II dose for subsequent clinical trials. The clinical study is being conducted at Memorial Sloan-Kettering Cancer Center in New York.
About LOR-253
LOR-253 represents a new class of anticancer agent, which we believe may offer a competitive advantage over classical drugs. This drug candidate has shown selective and potent antitumor activity in preclinical investigations with a variety of human cancers, including colon cancer and non-small cell lung cancer, and has demonstrated an excellent therapeutic window due to its low toxicity. LOR-253 is a first-in-class small molecule that has been optimized to inhibit the novel cancer target Metal-Responsive Transcription Factor 1 (MTF-1). MTF-1 is overexpressed in selective cancer indications, and its downregulation by LOR-253 results in induction of the novel tumor suppressor Krüppel-like factor 4 (KLF4), leading to the downregulation of cyclin D1, an important regulator of cell cycle progression and cell proliferation. MTF-1 downregulation also results in decreased expression of genes involved in the adaptation of tumors to hypoxia (low oxygen content) and angiogenesis. Increased angiogenesis and alterations in the cyclin D1 regulatory pathway have been linked to the development of cancer.
About Lorus
Lorus is a biopharmaceutical company focused on the discovery, research and development of novel therapeutics in cancer. Lorus’ goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. The Company also has expertise in antimicrobial drug discovery. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, statements relating to: our research program plans, our plans to conduct clinical trials, the successful and timely completion of clinical studies and the regulatory approval process, our ability to continue as a going concern, our ability to fund future research, our plans to obtain partners to assist in the further development of our product candidates, the establishment of corporate alliances, the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “believe”, “plan”, “expect”, “intend”, “will”, “should”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others: our ability to continue as a going concern, our ability to obtain the capital required for research and operations, the inherent risks in early stage drug development including demonstrating efficacy, development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our Annual Information Form underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
Lorus Therapeutics Inc.’s recent press releases are available through the Company’s website at www.lorusthera.com. For Lorus' regulatory filings on SEDAR, please go to www.Sedar.com.
Enquiries:
For further information, please contact:
Grace Tse, 416-798-1200 ext. 380; ir@lorusthera.com
Exhibit 99.2
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NEWS RELEASE |
Lorus Therapeutics Announces Positive Results from its Small Molecule
Antimicrobial Program
- Potent Antibacterial Activity of LOR-220 Includes Drug-Resistant “Superbugs” -
TORONTO, CANADA, March 27, 2012 - Lorus Therapeutics Inc. (TSX: LOR) (“Lorus”), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced promising results obtained from preclinical studies on its lead antimicrobial small molecule compound LOR-220.
The studies examined the antibacterial activity of LOR-220 against drug sensitive and drug resistant bacteria that had been isolated from patients with bacteremia and other bacterial infections. LOR-220 showed potent antibacterial activity against a panel of 330 clinical isolates of bacteria, including Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant enterococci (VRE) among the so-called “superbugs”. In addition, LOR-220 demonstrated higher antibacterial activity than that of Vancomycin and Linezolid, both of which are antibiotics currently used to treat serious bacterial infections.
LOR-220 also significantly improved survival of mice infected with two different species of VRE, which, when left untreated, led to 100% lethality. Lorus previously reported similar effects of LOR-220 in improving survival of mice infected with an epidemic strain of MRSA.
The study was carried out for Lorus by Sichuan Industrial Institute of Antibiotics, a research and development based pharmaceutical organization.
“One of the biggest healthcare concerns world-wide is the limited number of therapeutic options available to treat emerging infections caused by multi-drug resistant bacteria such as MRSA and VRE in hospitals and communities. A significant challenge for combating these infections is finding new antimicrobials that work against novel bacterial targets, to reduce or eliminate cross-resistance to existing antibiotics. These new data, generated against hundreds of clinical isolates, provide strong support for further development of LOR-220 and validate the potential of our antimicrobial program”, said Dr. Aiping Young, Lorus’ President and CEO.
Lorus currently focuses on the development of novel therapies for cancer treatment and has prioritized the development of its clinical stage small molecule drug candidate LOR-253, its immunotherapeutic agent, IL-17E, and its new small molecule program, LOR-500. The Company is in discussions with potential partners to advance the development of LOR-220 as a novel, first-in-class antimicrobial for the treatment of serious infections caused by Gram-positive bacterial pathogens.
About LOR-220
LOR-220 is a small molecule developed by Lorus that targets a class of novel bacterial proteins called kinases, which have recently emerged as critical signaling molecules in bacteria. Previous studies performed at Lorus using reference bacterial strains demonstrated activity of LOR-220 against multi-drug resistant Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and other pathogens that are emerging as a major cause of severe infections in hospitals and communities world-wide.
About Lorus
Lorus is a biopharmaceutical company focused on the discovery, research and development of novel therapeutics in cancer. Lorus’ goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. The Company also has expertise in antimicrobial drug discovery. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, statements relating to: our research program plans, our plans to conduct clinical trials, the successful and timely completion of clinical studies and the regulatory approval process, our ability to continue as a going concern, our ability to fund future research, our ability to obtain partners to assist in the further development of our product candidates, the establishment of corporate alliances, the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “believe”, “plan”, “expect”, “intend”, “will”, “should”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others: our ability to continue as a going concern, our ability to obtain the capital required for research and operations, the inherent risks in early stage drug development including demonstrating efficacy, development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our Annual Information Form underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
Lorus Therapeutics Inc.’s recent press releases are available through the Company’s website at www.lorusthera.com. For Lorus' regulatory filings on SEDAR, please go to www.Sedar.com.
Enquiries:
For further information, please contact:
Grace Tse, 416-798-1200 ext. 380; ir@lorusthera.com
Arash Shahi, 416-644-2020; ashahi@renmarkfinancial.com
Exhibit 99.3
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NEWS RELEASE |
Lorus Therapeutics Presents Positive Data for Lead
Anticancer Drug LOR-253
-New data presented at the 2012 annual meeting of the American
Association for Cancer Research (AACR)-
TORONTO, CANADA, April 3, 2012 - Lorus Therapeutics Inc. (TSX: LOR) (“Lorus”), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced the presentation of new preclinical data for Lorus’ anticancer drug, LOR-253, at the AACR annual meeting taking place March 31 - April 4, 2012 in Chicago, Illinois. The data supports the treatment of lung and colon cancers with LOR-253 in combination with a variety of chemotherapy agents.
The presentation entitled “Preclinical dose scheduling studies of LOR-253, a novel anticancer drug, in combination with chemotherapeutics in lung and colon cancers” will be given today during the 8:00 am - 12:00 pm session. The results of the study are summarized in an abstract prepared for the presentation (Abstract Number: 3710), and is available online on the AACR website (http://www.aacr.org).
The studies examined the anticancer activities of LOR-253, given in combination with approved anticancer agents, at different doses and schedules. The preclinical data showed that initial treatment of non-small cell lung cancer (NSCLC) cells with chemotherapy drugs docetaxel, paclitaxel, or cisplatin, followed by treatment with LOR-253, had significant and synergistic anticancer activity compared to either drug given alone. In animal studies, LOR-253 plus docetaxel showed significant efficacy against human NSCLC tumors when both drugs were administered at efficacious doses sequentially, compared to treatment with either agent alone at the same dose levels.
Similar anticancer synergy was also seen in colon cancer cells when LOR-253 was combined with the chemotherapeutics oxaliplatin, CPT-11, or fluorouracil. Each of these drugs are currently used for the treatment of colon cancer. In animal studies, LOR-253 plus oxaliplatin showed significant efficacy against human colon tumors when both drugs were administered sequentially, compared to either agent alone at the same dose levels.
“We’re very excited to present these findings on LOR-253 at the AACR Annual Meeting, which is an important international forum for cancer research and therapy,” said Dr. Aiping Young, Lorus' President and CEO. “The results of these studies are important because they demonstrate that LOR-253 significantly improves the antitumor activity of standard of care chemotherapy drugs used to treat NSCLC and colon cancer. These data also provide key information for designing clinical protocols for administering LOR-253 in drug combination strategies”
LOR-253 is in a Phase I clinical trial in patients with advanced or metastatic solid tumors who are unresponsive to conventional therapy, or for which no effective therapy is available. The Phase I study assesses the safety profile and antitumor activity of LOR-253, and will determine the recommended Phase II dose for subsequent clinical trials in combination with chemotherapeutics. The clinical trial is being conducted at the Memorial Sloan-Kettering Cancer Center in New York.
About LOR-253
LOR-253 represents a new class of anticancer agent, which we believe may offer a competitive advantage over conventional drugs. This drug candidate has shown selective and potent antitumor activity in preclinical investigations with a variety of human cancers, including colon cancer and non-small cell lung cancer, and has demonstrated an excellent therapeutic window due to its low toxicity. LOR-253 is a first-in-class small molecule that has been optimized to inhibit the novel cancer target Metal-Responsive Transcription Factor 1 (MTF-1). MTF-1 is overexpressed in selective cancer indications, and its downregulation by LOR-253 results in induction of the novel tumor suppressor Krüppel-like factor 4 (KLF4), leading to the down regulation of cyclin D1, an important regulator of cell cycle progression and cell proliferation. MTF-1 down regulation also results in decreased expression of genes involved in the adaptation of tumors to hypoxia (low oxygen content) and angiogenesis. Increased angiogenesis and alterations in the cyclin D1 regulatory pathway have been linked to the development of cancer.
About Lorus
Lorus is a biopharmaceutical company focused on the discovery, research and development of novel therapeutics in cancer. Lorus’ goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. The Company also has expertise in antimicrobial drug discovery. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, statements relating to: our ability to fund future research, our research program plans, our plans to conduct clinical trials, the successful and timely completion of clinical studies and the regulatory approval process, our ability to continue as a going concern, our ability to obtain partners to assist in the further development of our product candidates, the establishment of corporate alliances, the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “believe”, “plan”, “expect”, “intend”, “will”, “should”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others: our ability to continue as a going concern, our ability to obtain the capital required for research and operations, the inherent risks in early stage drug development including demonstrating efficacy, development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our Annual Information Form underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
Lorus Therapeutics Inc.’s recent press releases are available through the Company’s website at www.lorusthera.com. For Lorus' regulatory filings on SEDAR, please go to www.Sedar.com.
Enquiries:
For further information, please contact:
Grace Tse, 416-798-1200 ext. 380; ir@lorusthera.com
Arash Shahi, 416-644-2020; ashahi@renmarkfinancial.com