On July 7, 2010 Cancer Research Technology (CRT)* and Medical Research Council Technology (MRCT)** reported it will ‘swap’ medical discoveries to accelerate the translation of early scientific research into patient benefit (Press release, Cancer Research Technology, JUL 7, 2010, View Source [SID1234523336]).

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CRT and MRCT can offer each other rights to manage, develop and license discoveries from research funded by parent charity Cancer Research UK and the government’s Medical Research Council. The arrangement will explore ways to make the most of each organisation’s expertise and speed up the licensing of potential products for patient benefit.

CRT can offer MRCT the opportunity to manage, develop and license certain intellectual property *** outside the field of cancer. And in return MRCT can offer CRT the opportunity to manage, develop and license certain intellectual property **** with an application in cancer.

Dr Keith Blundy, CEO Cancer Research Technology said: "This is in effect a two-way skills transplant between two organisations with expertise in different areas of medical research.

"It’s a win-win-win – for CRT, for MRCT and also for patients. CRT has a solid expertise in forming global networks with industry partners to turn cancer discoveries into exciting ways to treat cancer with aim to increase survival.

"In return the arrangement lets us hand over discoveries from our researchers that fall outside of cancer to the technology transfer leaders in specific disease research fields.

"Both organisations can contribute their skills and knowledge to bring the maximum patient benefit across a range of diseases as efficiently and quickly as possible."

Dave Tapolczay, CEO of MRC Technology, said: "The strengthening of this partnership is of strategic importance. The arrangement will allow both MRC Technology and Cancer Research Technology to use their core strengths to maximise translation of discovery to benefit public health. We are confident this arrangement will speed up delivery of life-changing healthcare treatments and bring further value and strength to UK science."

Both CRT and MRCT will share revenue resulting from the arrangement – agreed on a case by case basis.

Dr Keith Blundy, CEO Cancer Research Technology added: "As well as each organisation providing management commercialisation skills, each will use drug discovery expertise to translate drug targets into commercial opportunities

"This is an enormously important arrangement which will save both organisations and industry money and time and achieve our common goals of increasing survival from a wide range of diseases."

On July 6, 2010 BioMS Medical Corp. (TSX: MS) reported it has changed its name to Medwell Capital Corp. ("Medwell" or "the Company") (Press release, BioMS Medical, JUL 6, 2010, View Source [SID:1234510643]). Shares of Medwell will continue trading on the Toronto Stock Exchange under the symbol ‘MS’ until the end of the trading on July 7, 2010. On Thursday, July 8, 2010, Medwell will begin trading under the new symbol ‘MWC’.

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The name change was approved by shareholders at the Company’s annual meeting held on June 25, 2010.

About Medwell Capital Corp.

Medwell Capital Corp. is a Canadian-based service provider in the healthcare industry. For further information please visit www.medwellcapital.com.

This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

On July 6th, 2010 Molecular Templates reported that it has entered into a collaborative oncology drug discovery and translation research agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (Press release Molecular Templates, JUL 6, 2010, View Source [SID:1234500725]).
Under the terms of the agreement, Molecular Templates will identify Engineered Toxin Bodies (ETBs) against an undisclosed oncology target of interest selected by ImClone. ImClone will conduct preclinical studies utilizing the ETBs to evaluate their therapeutic potential in oncology. Upon completion of the evaluation of the ETBs, Molecular Templates and ImClone have the option to continue exclusive development of selected ETBs by ImClone for potential commercialization by Lilly. Molecular Templates will receive upfront, milestone and royalty payments if any of the ETBs are selected for further development and commercialization. Financial terms of the agreement were not disclosed. "We are excited to partner with a premier biologics innovator like ImClone," said Eric Poma, president and chief executive officer of Molecular Templates. "We look forward to collaborating with ImClone to identify novel oncology therapies by leveraging our ETB technology. Given ImClone’s depth in the oncology and biologics arena, we view this partnership as validation of our novel platform and its potential to be used to discover and develop the next generation of targeted biologic medicines."
ETBs represent a new class of small biologic therapeutics derived from modified bacterial toxins that retain the potent direct cell-kill properties, internalization capabilities, and predictable pharmacokinetics of the parent toxins, but have significantly reduced immunogenicity. These features confer a host of advantages over traditional biologic and small molecule approaches and allow for discovery of therapeutic targets that may be uniquely accessible by ETBs. Molecular Templates has created a vast library (>10^15) of ETBs, each with distinct binding affinities, that can be directly screened for cell-kill ability to rapidly identify promising therapeutic candidates based on both specificity and efficacy to a given target.

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Cancer, ovarian
It is in a Phase I/II tumor specific vaccination therapy for advanced/recurrent ovarian cancer using HLA-A*2402 restricted specific epitope peptides cocktail derived from tumor genome/tumor related angiogenetic factors genome (Clinical trial, Trial ID:UMIN000003862, UMIN, JUL 2, 2010, View Source [SID1234520548]). Advanced/recurrent ovarian cancer with the conditions of unremoval by surgery, or refractory, chemo-resistant disease. Objective 1: To elcidate the feasibility and efficacy of HLA-A*2402 restricted Specific Epitope Peptides Cocktail of FOXM1,MELK,HJURP,VEGFR(vaacular endotherial growth factor receptor)-1 and VEGFR2. Objective 2: Safety,Efficacy.

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On June 21, 2010 Pfizer Inc. reported the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer (Press release, Pfizer, JUN 21, 2010, View Source [SID1234634976]). The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

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Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.

Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.

Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.

A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.

"Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. "However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML."

As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.

Mylotarg is manufactured by New York City-based Pfizer.

For more information:

Pfizer: Mylotarg Withdrawal

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FDA: Access to Investigational Drugs

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