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KDev Oncology AB invests in GliGene AB

On February 14, 2012. GliGene AB, a new Swedish drug
development company focusing on cancer diseases, has received its first
financing through a new share issue directed to KDev Oncology AB, a wholly owned
subsidiary of Karolinska Development AB (Press release, GliGene, FEB 14, 2012, http://www.karolinskadevelopment.com/?cID=551&pid=600939&did=490625&y=2012&m=02 [SID1234516060]). The new share issue will enable GliGene
to advance the discovery of new antagonists to the Hedgehog pathway. KDev
Oncology’s investment at SEK 6.8m will result in an ownership in GliGene at
44%*.

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GliGene is an early stage drug development company that discovers, develops and
commercializes new targeted therapies for cancer patients. The discovery effort
is based on world class research at Karolinska Institutet by Prof. Rune Toftgård
and colleagues, who are co-founders of the company.

In developed countries approximately 35% of all deaths are caused by malignant
tumors. Cancer is usually treated with a combination of surgery, chemotherapy,
targeted therapy and radiotherapy. GliGene will focus its discovery activities
on the Hedgehog signaling pathway. This pathway is one of the key regulators of
animal development and plays a fundamental role in the control of cell
differentiation, growth, and proliferation. The Hedgehog signaling pathway
becomes reactivated in cancer, and is not likely to be required in most normal
adult tissues. Thus, inhibition of this pathway may provide a selective way of
treating cancer.

Dr. Carl Harald Janson, CEO, KDev Oncology AB, and Chairman of the Board,
GliGene AB:
"We are delighted to announce the start of GliGene and the first investment in
the company. We are very happy to have Prof. Rune Toftgård and his colleagues as
co-founders in the company. Their contribution will be of great importance for
our future success."

Prof. Rune Toftgård, Center for Biosciences, Karolinska Institutet:
"It is a pleasure to be part of GliGene and we look forward to see science
provide benefit to cancer patients. We appreciate the investment by KDev
Oncology and look forward to a fruitful relationship."

Dr. Torbjörn Bjerke, CEO, Karolinska Development AB:
"GliGene is the first investment by KDev Oncology, our newly formed, fully owned
oncology group. This marks the start of our enhanced effort in oncology, an area
of strategic importance to Karolinska Development. The cancer market is
currently valued at around USD 80bn and is one of the fastest growing segments
in the pharma industry. "

*Including indirect ownership through KCIF Co-Investment Fund at 3.9%.

For further information, please contact:
Carl Harald Janson, CEO, KDev Oncology AB, and Chairman of the Board, GliGene AB
Phone: +46 (0) 70 226 91 52, e-mail:
[email protected]

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0) 72 744 41 23, e-mail: [email protected]

(Press release, Cannabis Science, FEB 1, 2012, View Source [SID:1234505818])

Spectrum Pharmaceuticals In-Licenses a Novel, Long-Acting GCSF Drug in U.S. Clinical Trials from Hanmi Pharmaceuticals

On January 31, 2012 Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported that it has entered into a co-development and commercialization agreement with Hanmi Pharmaceutical Company for SPI-2012 (formerly known as "LAPS-GCSF"), a drug for the treatment of chemotherapy induced neutropenia based on Hanmi’s proprietary LAPSCOVERY Technology (Press release, Spectrum Pharmaceuticals, JAN 31, 2012, View Source [SID:1234508777]).

Granulocyte colony-stimulating factor (GCSF) stimulates the production of white blood cells by the bone marrow. A recombinant form of GCSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule. Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments. The worldwide market for GCSF-related drugs was over $5 billion in 2011.

LAPSCOVERY (Long Acting Protein/Peptide Discovery) is a platform technology that can be applied to various molecules including glycosylated proteins, modified or artificial peptides with unnatural amino acid sequences. LAPSCOVERY can select the optimal conjugation sites from the proteins or peptides to minimize the structural hindrance and maximize the pharmacological activity.

"We were very impressed by Hanmi’s platform technology and are delighted to add SPI-2012, our third biologic drug, to our mid-stage pipeline," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Early evidence suggests that there could be advantages of SPI-2012 over currently approved therapies in increasing the rate and intensity of neutrophil recovery. We believe this agreement is consistent with our strategy of acquiring promising drug candidates at reasonable upfront and developmental costs, while maintaining significant economics for our shareholders in the long-term."

"Spectrum Pharmaceuticals has a proven history in in-licensing, developing and commercializing drugs. As a result, we expect this collaboration to help significantly advance SPI-2012 through the clinical and regulatory pathways, and commercial success," said Dr. Gwan-Sun Lee, Chief Executive Officer and President of Hanmi Pharmaceuticals.

CURIS ANNOUNCES FDA APPROVAL OF ERIVEDGE (VISMODEGIB) CAPSULE AS FIRST TREATMENT FOR ADVANCED BCC

On January 30, 2012 Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, reported that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation (Press release, Cancer Research Technology, JAN 30, 2012, View Source [SID1234523521]). Erivedge is the first and only FDA-approved medicine for people with advanced forms of the most common skin cancer. It is being developed and will be commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech.

GDC-0449, a first-in-class hedgehog pathway inhibitor, was initially identified as a developmentally related gene in drosophila at the London Research Institute (Phil Ingham in collaboration with Harvard scientists). CRT subsequently licensed Hedgehog IP to Curis in 1995.

Dr Keith Blundy, Cancer Research Technology’s CEO, said: "We’re delighted that Vismodegib has been approved by the FDA ahead of the March deadline. This announcement brings us a step closer to approval in Europe by the EMA.

"The target of this drug, a signalling pathway called hedgehog, was co-identified by a team of Cancer Research UK scientists in the 1990’s and it is a great example of how early basic research funded by the charity can be translated into patient benefit."

For more information, view the Curis press release.

CRT spins out company to develop cancer surgery machine to melt tumours

On January 26, 2012 Cancer Research Technology, the commercial arm of Cancer Research UK, reported it has launched Acublate Limited, a spin-out company which will develop a next-generation High Intensity Focused Ultrasound (HIFU) surgery device to treat a range of solid tumour types (Press release, Acublate, JAN 26, 2012, http://commercial.cancerresearchuk.org/crt-spins-out-company-develop-cancer-surgery-machine-melt-tumours [SID1234523125]).

HIFU is a highly precise non-invasive type of surgery which uses ultrasound energy to heat and destroy tumours while leaving surrounding healthy tissue intact. The treatment works with immediate benefit and has the potential to reduce side effects compared with current alternative treatments.

The Acublate device uses an advanced proprietary phased-array system – that is, it targets multiple points in the tumour at once. The system can be steered rapidly in 3D to target and destroy tumours.

It is expected that the device will significantly reduce HIFU treatment times and become a more effective and cheaper alternative to currently available HIFU therapies for the treatment of cancer and other chronic diseases.

Initially, the Acublate device will treat patients with bowel cancer that has spread to the liver. But the technology has the potential to treat a range of cancers.

Cancer Research UK, Imperial Innovations and Imperial College Healthcare NHS Trust funded the original research to develop the technology. The research was led by founding scientists physicist Professor Jeff Hand at Imperial College London and surgeon Professor Paul Abel at Imperial College London.

Cancer Research Technology, with others, has raised £145,000 to develop the clinical prototype which is expected to be ready within a year. Further funding will be required to run clinical trials of the equipment with the first clinical data expected within 24 months.

Cancer Research Technology, which owns the IP to the technology, is Acublate Limited’s major equity holder and will benefit from any future licence income

Tony Hickson, managing director technology transfer, at Imperial Innovations, said: "As the provider of commercialisation services to the Imperial College Healthcare Trust, Imperial Innovations is extremely pleased to see this cutting-edge treatment being developed by a Cancer Research UK spin-out, and, alongside the ICHT and CRT, has backed the idea, supporting the development of the prototype towards clinical trials."

Dr Keith Blundy, CRT’s CEO, said: "We’re delighted to be able to take the research into this exciting technology that Cancer Research UK helped fund onto the next stage. The HIFU technology currently approved for clinical use in the UK specifically targets prostate cancer but we hope the Acublate device will be able to treat most solid tumour types.

"It’s also expected to treat patients more quickly, more effectively and with fewer side effects than the current technology.

"We hope to have the first set of data from clinical trials using the equipment to treat bowel cancer that has spread to the liver, within two years."