Improved method for treatment of neovascularization

FIELD: medicine.

SUBSTANCE: invention proposes a method for inhibition of chorionic neovascularization. Method involves irradiation of undesirable novel vascular reticulum in combination with photosensitive agent (porphyrine) and an anti-angiogenic agent taken among antagonist of phospholipase A2, inhibitor of complex kappa B, inhibitor of the growth hormone, inhibitor of insulin-like growth factor-1, inhibitor of cyclooxygenase II, inhibitor of protein kinase C (stautosporin PKC 412) and inhibitor of angiotensin II. The claimed combined treatment provides potentiation of effect of adjunctive photodynamic therapy in combination with enhanced safety.

EFFECT: improved treatment method.

7 cl

 

The invention relates to an improved method for the treatment of subfoveal choroidal neovascularization (CNV) using photodynamic therapy (PDT) or phototherapy using antiangiogenic agent as a secondary drug.

The present method of treating age-related macular degeneration (AMD) using photodynamic therapy using the corresponding photosensitive agent allows you to get a very good short-term results in the treatment of CNV and has a significant advantage compared with laser photocoagulation. However, it was found that patients who were treated with PDT, is the resumption of choroidal neovascularization in the field, exposed to processing, and/or development of new lesions outside the scope of the initial damage (the so-called progressive development), which requires re-PDT. Therefore, it is very important to the development of the way pharmaceutical treatment, which can be used in combination with PDT and which prevents the growth of new blood vessels; it could be used for the treatment of CNV. Prevention of the development of new unwanted vascular network can reduce the required number of treatments using the DT for some patients. This method can also be used to treat other types of eye tissue, as well as in the treatment-induced neovascularization lesions of the retina.

Thus, one of the objects of the present invention is an improved method of treatment aimed at eliminating the patient's unwanted new vascular network, due to CNV, which provides:

(a) introduction to the patient an effective amount of antiangiogenic drugs;

(b) introduction to the patient an effective amount of a photosensitive agent; and

(C) exposure to unwanted new vascular network of light with a wavelength, which is the absorbance of the photosensitive agent.

The next object of the present invention is the use of antiangiogenic drugs in combination with a photosensitive agent to obtain a medicinal product intended for improved photodynamic treatment aimed at eliminating unwanted new vascular network, due to the CNV, the patient, preferably in humans.

Another object of the invention is the use of antiangiogenic drugs in combination with a photosensitive agent to obtain a medicinal product intended for improved photodynamic treatment the Oia, for elimination of unwanted new vascular network, due to the CNV, the patient, preferably in humans, and more effective photodynamic treatment involves the following stages:

(a) introduction to the patient an effective amount of antiangiogenic drugs;

(b) introduction to the patient an effective amount of a photosensitive agent; and

(C) exposure to unwanted new vascular network of light with a wavelength, which is the absorbance of the photosensitive agent.

In the claimed invention, it was found that the introduction of antiangiogenic drugs can be used in combination with photodynamic therapy for the treatment of a patient who developed unwanted new vascular network, due to CNV.

Treatment with PDT is widely known in this area, it typically involves applying a photosensitive agent that is activated by the laser. The preferred method of treatment with PDT using a photosensitive agent and the laser treatment Protocol described in granted European patent EP 680365 B1 and international patent application WO 97/33619. When PDT photosensitive agent make in ocular tissue, damaged CNV (i.e., eye the target tissue), and activate the laser with a wavelength which is absorbed by photocosmetic is the principal agent. According to the present invention antiangiogenic drug is administered before, after and/or simultaneously with the photosensitive agent used in the treatment using PDT. Treatment method, in which the use of PDT in combination with antiangiogenic drug, called adjunctive PDT.

Antiangiogenic drug, you can enter either sequentially or simultaneously with a photosensitive agent, while it is preferable to sequential introduction. Thus, in the context of the present description the term "in combination with" should be understood in accordance with the above definitions. For example, the sequential processing antiangiogenic drug, you can enter for 1-4 weeks, more preferably for 0.5 to 1.5 weeks before the introduction of the photosensitive agent for PDT. Alternatively, sequential processing antiangiogenic drug can be introduced through the 0-4 weeks, more preferably 0-1 through week after administration of the photosensitive agent for PDT. If necessary antiangiogenic drug can be entered consistently both before and after PDT according to the scheme described above. In contrast, the treatment is considered simultaneous if antiangiogenic drug is administered in conjunction with a photosensitive agent. For some patients may require several treatments using adjunctive PDT or treatments using adjunctive PDT using antiangiogenic drugs, and for individual treatments with adjunctive PDT may require repeated introduction of antiangiogenic drugs.

In the context of the present description, the concept of antiangiogenic drugs means drugs, the action of which causes a prevention, inhibition or reversal of the growth of new blood vessels that occur in the process, widely known as angiogenesis. Examples of antiangiogenic drugs, which can be used in adjunctive PDT are staurosporine, for example N-benzoylthiourea, somatostatin, such as octreotideand steroids, such as triamcinolone. Other antiangiogenic drugs, which can be used according to the present invention are inhibitors of VEGF (vascular endothelial growth factor), such as CGP 79987D, CGP V or CGP 53716

etc. Such antiangiogenic drugs are particularly suitable for ing is berbania resume re-opening, development and/or growth of blood vessels that occur in the process choroidal neovascularization, and greatly enhance the efficiency adjunctive PDT.

Preferably antiangiogenic drug selected from the group including inhibitors of protein kinase C (PKC) (for example, N-benzoylthiourea), inhibitors of growth hormone and IGF-1 (e.g., octreotide), inhibitors of vascular endothelial growth factor (VEGF) (e.g., CGP 79787, N-benzoylthiourea ITSELF 781)inhibitors of cyclooxygenase II (for example, diclofenac, SOH 189), inhibitors of angiotensin II (e.g., valsartan), inhibitors of NF-K b and PLA2 antagonists, more preferably from the group comprising the inhibitors of the RCC, inhibitors of VEGF and inhibitors of growth hormone and IGF-1.

More preferably antiangiogenic drug is chosen from the group comprising the inhibitors of the RCC and VEGF, especially inhibitors of the RCC. The most preferred antiangiogenic drug is a compound from the group comprising N-benzoylthiourea, CGP 79787 and octreotide, primarily N-benzoylthiourea.

Preferably, the photosensitive agent is chosen from the group comprising chlorine, bacteriochlorin, phthalocyanine, porphyrin, purpurine, merocyanin, pheophorbide and psoralen.

The most preferred photoacustic inim agent is the agent, selected from the group of porphyrins, and it is normally the so-called green porphyrin or BPD-MA.

In the method according to the invention can be applied to any of the above-described photosensitive compounds. Obviously, you can apply a mixture of two or more photosensitive compounds; however, because the efficacy of treatment depends on the absorption of light of a photosensitive compound, when applied mixture, are preferred components having similar absorption maxima.

The nature of the composition used for the introduction of antiangiogenic drugs or photosensitive agent depends, in particular, on the route of administration and nature of the selected antiangiogenic drugs and a photoactive agent. You can use any pharmaceutically acceptable excipient or combination of excipients suitable for use in conjunction with a specific active substances. So, for example, photosensitive agents or antiangiogenic substance can be introduced in the form of aqueous compositions, compositions, penetrating through the mucous membrane, or transdermal compositions by injection into subtenancies space or intraocular injection or as an oral composition. The composition may also contain liposomes. Lipozone is oppozitsii are the most preferred in the case when the photoactive agent is a green porphyrin. Antiangiogenic drug is preferably introduced with the use of water media.

The above compounds can be entered in any of numerous ways, such as oral, parenteral or rectal, or you can enter them directly in the eye, or place on it. The photosensitive agent is preferably administered parenterally, for example intravenously, intramuscularly or subcutaneously. Most preferred is the introduction by intravenous injection. For the introduction of the antiangiogenic agent is preferred oral administration or introduction into the eye.

The dose of the above compounds may vary within wide limits depending on the route of administration, the compositions of which they are composed, for example in the form of liposomes, or whether they are associated with specific respect to the target ligand, such as an antibody or fragment having immunological activity. It is generally recognized that there is a relationship between the type photoactive agent, composition, route of administration and the dose level. Antiangiogenic drug is administered in such manner and in such quantity, which provide the impact of drugs on unwanted new vascular network. Fotos stitely agent enter in the quantity effective to ensure that unwanted blockage of a new vascular network.

Although for different photoactive agents require different doses, if the use of green porphyrins, as a rule, the dose is 0.1-50 mg/m2the surface area of the body, preferably approximately 1 to 10 mg/m2most preferably about 2-8 mg/m2.

Although various antiangiogenic compounds require different doses, as a rule, the dose of 1-500 mg/kg body weight, preferably approximately 10-250 mg/kg

Irradiation (laser power, duration of exposure) is carried out in accordance with the methods known from the existing art, for example in accordance with the Protocol processing light, described in WO 97/33619.

1. The improved method of treating unwanted new vascular network, due to the choroidal neovascularization (CNV) in a subject, which includes

(a) introduction to the patient an effective amount of antiangiogenic drugs, where antiangiogenic drug is selected from inhibitors of protein kinase C (CSWs), inhibitors of growth hormone and insulin-like growth factor 1 (IGF-1), inhibitors of vascular endothelial growth factor (VEGF), inhibitors of cyclooxygenase II, inhibitors of angiotensin II inhibitors the gender factor In Cannes (NF-kB) and antagonists of phospholipase A2 (PLA2);

(b) introduction to the patient an effective amount of a photosensitive agent and

(C) exposure to unwanted new vascular network of light with a wavelength, which is the absorbance of the photosensitive agent.

2. The method according to claim 1, where the antiangiogenic drug is administered in 1-4 weeks before the introduction of the photosensitive agent.

3. The method according to claim 1, where the introduction of antiangiogenic drugs and photosensitive agent is carried out at the same time.

4. The method according to claim 1, where the antiangiogenic drug is injected through 1-4 weeks after administration of the photosensitive agent.

5. The method according to claim 1, where the antiangiogenic drug is selected from inhibitorof PKS and VEGF, primarily from PKC inhibitors.

6. The method according to claim 1, where the antiangiogenic drug is selected from N-benzoylthiophene, 1-(4-chloroanilino)-4-(4-pyridylmethyl)phthalazine (CGP 79787) and octreotide, most preferably the agent is a N-benzoylthiourea.

7. The method according to claim 1, where the photosensitive agent is selected from a porphyrin and purpurine, most preferably the agent is a porphyrin.



 

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